The Intelligent Surgical Unit powers the Senhance surgical robot system. | Source: Asensus Surgical

Asensus Surgical Inc. today announced that it has entered into a non-binding letter of intent for medical device company Karl Storz SE to acquire it.

The agreement enables Karl Storz to engage in due diligence and negotiations over a potential acquisition of the surgical robot maker. Asensus and Karl Storz began ollaborating on plans for development and marketing just over a year ago.

Entry into the letter of intent (LOI) follows an extensive period of consideration of strategic alternatives, stated Asensus. That included potential collaborations and licensing transactions, a “go-it-alone” strategy reliant upon significant fundraising, a sale of the company, or additional development transactions.

Instead, the company’s board approved the LOI with Karl Storz, which includes a proposal to acquire 100% of the issued and outstanding shares of Asensus common stock at 35¢ per share in cash. That represents a 66.7% premium to the closing price of Asensus stock on April 2, 2024. Karl Storz said that the proposed price represents its “best and final offer.”

Asensus developing Senhance, Intelligent Surgical Unit

Research Triangle Park, N.C-based Asensus is developing the Senhance surgical robot. It has also developed the Intelligent Surgical Unit (ISU) for Senhance.

The company said it designed ISU as a real-time intraoperative surgical image analytics platform. It uses “augmented intelligence” to help reduce surgical variability.

Asensus unveiled its the next-generation LUNA robot in February 2023. The integrated digital system features a next-generation surgical platform and instruments, plus real-time intraoperative clinical intelligence. Its final component, a secure cloud platform, applies machine learning to deliver clinical insights.

The company suggested last year that it targeted 2025 for U.S. Food and Drug Administration (FDA) clearance for LUNA. In November, Asensus inked a manufacturing deal for its platform.

In January 2024, the company showed LUNA off to surgeons, conducting an in vivo lab evaluation of the next-generation surgical robot. 

More details on the LOI

The letter of intent provides that, during an exclusivity period of up to 10 weeks, Asensus won’t engage in negotiations for alternative transactions. During that period, Karl Storz intends to conduct diligence as the companies negotiate a merger. Both companies have the right to terminate pursuit of the proposed transaction.

In connection with the LOI, Asensus entered into a fully secured promissory note or bridge loan with Karl Storz. This allows the company to receive a loan of up to $20 million from Karl Storz to support operations through the exclusivity period and beyond.

The companies said they plan to work during the exclusivity period to negotiate and finalize a merger agreement. If agreed, Asensus said it would then plan to quickly secure stockholder approval.

Asensus said it can’t provide any assurances of a final agreement with Karl Storz.

Asensus Surgical to speak at Robotics Summit

Dustin Vaughan, vice president of robotics research and development at Asensus, will be speaking at the Robotics Summit & Expo, which takes place on May 1-2 at the Boston Convention and Exhibition Center.

His talk, “Leveraging Real-Time Data Insights in the Operating Room” will explore the development and introduction of cutting-edge technologies, sensing modalities, and real-time data collection capabilities of the LUNA Surgical Platform and the practical implementation of those capabilities.

The Robotics Summit & Expo focuses on the design, development, and scaling of commercial robots. WTWH Media, which also produces The Robot Report, said it expects a record 5,000 attendees and more than 200 exhibitors. The event will be co-located with DeviceTalks, an event focused on medical devices, and the inaugural Digital Transformation Forum. Registration is now open for the event.

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Editor’s Note: This article was syndicated from MassDevice, a sibling site to The Robot Report.

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Titan Medical’s Enos system can assist surgeons. | Source: Titan Medical

Titan Medical announced today that it entered into a definitive amalgamation agreement to combine with Conavi Medical.

The companies aim to combine in an all-stock transaction, focusing on commercializing Conavi’s Novasight Hybrid system. Conavi designed Novasight Hybrid to guide common minimally invasive coronary procedures.

This merger comes after more than a year of uncertainty around the future at Titan Medical. In late 2022, Titan suspended a special meeting of shareholders meant to vote on a share consolidation plan. Management decided to begin a strategic review, with a sale of the company considered a possibility. Titan also announced cost-cutting measures that included the furloughing of 40 employees.

In a news release, the company said it conducted outreach to more than 40 potential counterparties and halted the development of its ENOS surgical robot in February 2023. To avoid insolvency, the company began selling assets and licensed its IP. It struck deals on that front in May, June and August 2023, including licensing surgical robotics IP to market leader Intuitive Surgical.

Titan said it determined that merging with another surgical robotics company was “not a viable option.” It expanded its search and landed on Conavi.

“This merger is the result of a thoughtful and careful review of strategic options and reflects the continued commitment of our management team and board of directors to deliver value to shareholders,” said Paul Cataford, Titan’s interim CEO and board chair. “Conavi is an exciting commercial-stage company with groundbreaking technology and an accomplished management team. We are confident in their ability to continue to drive adoption of the Novasight Hybrid system.”

More about Conavi Medical

Conavi Medical designs, manufactures and markets imaging technologies for guiding minimally invasive cardiovascular procedures. Novasight Hybrid combines both intravascular ultrasound (IVUS) and optical coherence tomography (OCT) to enable simultaneous and co-registered imaging of coronary arteries.

The Novasight Hybrid system has FDA 510(k) clearance and regulatory nods in other geographies like Canada, China and Japan.

With Titan Medical, Conavi expects the combined company to become a commercial-stage leader in hybrid intravascular imaging.

“This planned merger comes at a pivotal moment in the evolution of our company as we continue to advance the Novasight Hybrid system, which provides simultaneous and complementary data with which to better inform patient care, while offering providers a more cost- and space-effective option when purchasing intravascular imaging equipment,” said Conavi CEO Thomas Looby. “Gaining access to the public capital markets will enhance our financial strength and fuel our growth strategy, enabling us to unlock the full potential of our hybrid imaging technology in the United States and globally.”

More details on the Titan Medical-Conavi Medical merger

Under the terms of the agreement, Titan plans to acquire all issued and outstanding shares of Conavi. In exchange, Conavi shareholders, receive common shares of Titan. The deal constitutes a reverse takeover of Titan. In connection with the merger, Titan expects to delist its common shares from the Toronto Stock Exchange. Instead, they will be listed on the TSX Venture Exchange.

The companies expect the transaction to close on or around July 15, 2024.

Titan plans to effect a consolidation of its shares. As a condition to the completion, Conavi plans to complete a concurrent financing of subscription receipts. The companies anticipate minimum gross proceeds of $15 million with a maximum of $20 million.

Following the consolidation and concurrent financing, a wholly-owned Titan subsidiary will amalgamate with Conavi. Oustanding post-consolidation Titan shares then go to Conavi shareholders. The companies value Conavi at $69.84 million and the deal includes an allocation of $5 million in the pre-transaction valuation of Titan.

Titan plans to hold a special and annual meeting of shareholders to approve a number of conditions within the deal. That includes the change of the name from Titan Medical to Conavi Medical, or such other name as approved by their boards. Other conditions include the consolidation and a new equity incentive plan.

Editor’s Note: This article was syndicated from The Robot Report’s sister site MassDevice. 

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MIRA features a small, self-contained surgical device that can perform abdominal surgeries. | Source: Virtual Incision

Virtual Incision announced that the FDA granted marketing authorization to its MIRA miniaturized surgical robotic system.

The FDA gave the nod for the use of the miniRAS (robotic-assisted surgery) system in adults undergoing colectomy procedures. MIRA went through the FDA’s de novo classification process, with findings based on an investigational device exemption (IDE) study.

Virtual Incision’s MIRA system features a small, self-contained surgical device. Inserted through a single midline umbilical incision in the patient’s abdomen, it allows for complex, multi-quadrant abdominal surgeries. The system also uses existing minimally invasive tools and techniques that are familiar to surgeons. Altogether, MIRA weighs about two pounds.

According to the company, the system’s tray-to-table design could provide the advantages of robotic surgery without requiring them to organize the operating room around the device — a current challenge with surgical robots.

“Today marks a turning point in surgical robotics as we have hit a significant milestone in making miniaturized robotic surgery a reality,” said Virtual Incision President and CEO John Murphy. “For more than a decade, our team has been dedicated to our core mission of making every operating room robot-ready. I’m incredibly proud to see our efforts come to fruition. We extend our gratitude to the FDA for its thoughtful review of MIRA’s technology and our clinical evidence.

“Whether as a complement to the existing mainframes or as a stand-alone platform, miniaturization has the potential to accelerate the adoption of robotic-assisted surgery.”

Hear from Virtual Incision during the Surgical Robotics Week series next month.

How the Virtual Incision MIRA system got here

A surgeon holds the miniature MIRA surgical robot. | Source: Virtual Incision

The MIRA platform received IDE approval in October 2020, followed by approval for an IDE supplement in April. Virtual Incision submitted MIRA to the FDA for de novo review in May 2023. Notably, MIRA went to space last month, with NASA awarding a grant to use the system on a 2024 technology demonstration mission.

In November 2021, Virtual Incision completed a $46 million Series C financing round to support the robotic surgery platform. Virtual Incision then raised $30 million more in September 2023.

Virtual Incision plans to begin commercialization of MIRA through a first access program across select U.S. centers. It plans to ramp up production and expand to additional sites over time. The company also hopes to pursue additional indications, including gynecology, general surgery, urology and other soft tissue and solid organ surgery.

It plans for gynecological procedures in 2024. Additionally, the company has a new iteration of the technology tailored for general surgery in its design stage. It expects first-in-human uses outside the U.S. later this year.

Editor’s Note: This article was syndicated from The Robot Report’s sister site MassDevice. 

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The ROSA Shoulder System for robot-assisted surgery. | Source: Zimmer Biomet

Zimmer Biomet announced last week that it received FDA 510(k) clearance for its ROSA Shoulder System, which it claimed is the first surgical robot for shoulder replacement. It is also the fourth application for the Robotic Surgical Assistant, which includes the ROSA Knee System for total knee arthroplasty and the ROSA Hip System for total hip replacement.

“We are proud and excited to be the first company in the world to deliver a robotic surgical assistant for anatomic and reverse shoulder-replacement surgery,” said Ivan Tornos, president and CEO of Zimmer Biomet, in a release. “ROSA Shoulder represents a novel advancement intended to help surgeons leverage the power of robotics and data analytics to perform highly complex shoulder procedures with accuracy and efficiency.”

With more than 90 years of experience, Zimmer Biomet said it offers an integrated suite of digital and robotic technologies that use data, data analytics, and artificial intelligence. The Warsaw, Ind.-based company has operations in over 25 countries and sales in over 100 countries.

Zimmer Biomet adds to portfolio

Zimmer Biomet said ROSA Shoulder joins its shoulder-implant portfolio, which includes the Identity Shoulder System. The robot also joins the ZBEdge Dynamic Intelligence platform, which is intended to enhance the Zimmer Inc. unit‘s digital technologies, robotics, and implants. 

The company said it designed ROSA Shoulder to give surgeons flexibility and to enable precise placement for improved outcomes. It is one of the only systems that can reproduce humeral head resectioning, asserted Zimmer Biomet.

ROSA can also ease the insertion of instruments into incisions by requiring no pin in the center of the glenoid during procedures, it explained.

As with other ROSA applications, the shoulder system supports data for physician decision-making based on unique anatomies, said Zimmer Biomet. Pre-operatively, it integrates with the newly released Signature ONE surgical planning system. Signature ONE uses a 3D image-based approach to visualization, surgical planning, and patient-specific guide creation.

During the surgery, the platform provides surgeons with real-time, intra-operative data to help them control, execute, and validate personalized plans for glenoid and humeral placement. Zimmer Biomet said this is in pursuit of the goal of reducing complications for patients.

ROSA Shoulder will work with the mymobility Digital Care Management Platform, adding to the ZBEdge Dynamic Intelligence portfolio for patients undergoing shoulder-replacement surgery.

ROSA gives Mayo Clinic data before and during surgeries

“One of the challenging aspects of performing a shoulder replacement is accurate glenoid and humeral placement, which is a critical factor for post-operative function and long-term implant survival,” stated John W. Sperling, M.D., MBA, and a professor of Orthopedic Surgery at Mayo Clinic.

“This innovative approach is designed to allow surgeons to virtually walk through a procedure before making any resections, and then receive live feedback and the ability to control glenoid ream depth and intra-operatively validate cut resections during the procedure,” he said.

Mayo Clinic has a financial interest in Zimmer Biomet’s technology and said it will use any revenue it receives to support its not-for-profit mission in patient care, education, and research. 

Zimmer Biomet said ROSA Shoulder will be commercially available in the U.S. in the second half of 2024.

Editor’s note: This article was syndicated from The Robot Report sibling site MassDevice. 

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Researchers at the Wyss Center work on the Synapsuit exosuit project. | Source: Wyss Center

Researchers at the Wyss Center have an ongoing project to develop AI algorithms that use brain signals to control a lightweight exosuit.

The Synapsuit project aims to develop high-performance algorithms that decode complex brain signals. In turn, these signals control a lightweight, soft, wearable exosuit that supports arm and hand movement in real-time. The Wyss team collaborates with local and international partners on this project aimed at accelerating neuro-rehabilitation.

“Neuroscience is rapidly merging with AI, allowing us to discover important patterns hidden inside seemingly chaotic brain signals,” said Dr. Kyuhwa Lee, principal investigator, Wyss Center. “Using cutting-edge machine learning approaches, we aim to translate movement intentions into action for people living with movement disorders following spinal cord injury and stroke.”

Wyss plans to continue partnering to explore “new standards of neuro-AI technologies.” The group aims to assist people living with severe upper-limb motor disabilities to produce arm and hand movements. To achieve this, the team plans to gather large amounts of clinical data using flexible, high-density ECoG electrodes and develop new AI algorithms to decode the movement intentions of people experiencing motor disability.

More about the Wyss Center exosuit project

The components that make up the Synapsuit. | Source: Wyss Center

One partner in the exosuit project is Nuerosoft Bioelectronics, a brain-computer interface (BCI) technology maker.

“At Neurosoft Bioelectronics, we are committed to pushing the boundaries of BCI technology,” said CEO Dr. Nicolas Vachicouras. “Our cutting-edge, soft implantable electrodes offer a novel way to record signals from previously unexplored brain regions. By integrating these electrodes into the Synapsuit project, we aim to significantly improve the decoding of movement intentions, thereby taking a critical step towards restoring functional mobility to those who need it most.”

Combining the algorithms with a brain-controlled exosuit could accelerate neuro-rehab methods, Wyss says, by supporting the movement of those suffering from stroke and spinal cord injury.

The team records brain signals using soft, foldable, and flexible electrodes that conform to any neural tissues. They then feed the signals into the neuro-AI decoder that sends a command to the fully flexible, soft exosuit. The exosuit sends an electrical current through transcutaneous neurostimulation, controlling the muscle that directly moves the arm and the hand.

Combined with a special material called electrostatic clutch (ES-clutch), the exosuit allows the arm and hand to hold posture on demand without causing fatigue.

“We want to develop a highly usable, practical exosuit that can be used in daily life by people living with motor disability,” said Dr. Yun-Jae Won, principal investigator, Korea Electronics Technology Institute.

Editor’s Note: This article was syndicated from The Robot Report’s sister site Medical Design & Outsourcing. 

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Medical Microinstruments announced today that it raised $110 million in a Series C financing round to help commercialize its surgical robot.

Fidelity Management & Research Company led the round. Medical Microinstruments said in a news release that it marks the largest-ever investment in microsurgery innovation.

The company plans to use the funds to support the commercialization of its Symani surgical system in high-growth markets. Other uses include the continued investment in studies that generate clinical evidence and enable indication expansion. The company also expects to use funds to accelerate advanced technology capabilities to enable the scaling of global operational capabilities.

Pisa, Italy-based Medical Microinstruments’ Symani received CE mark in 2019, and the company continues to work on U.S. commercialization. It also has eyes on the Asia Pacific region. The first-of-its-kind robotic technology enables expanded adoptions for patients in need of soft tissue open surgical procedures.

The Symani system aims to address the challenges of microsurgery with its NanoWrist instruments. These instruments help to access and suture small, delicate anatomies. That includes veins, arteries, nerves and lymphatic vessels as small as 0.3mm in diameter. It provides motion scaling and tremor reduction to allow precise micro-movements.

Medical Microinstruments and its existing investors say they see “considerable opportunity” for rapid growth. All of those existing investors contributed to the Series C. The company has brought in more than $200 million in funding to date, including a $75 million Series B in 2022.

“Against a backdrop of plateauing investments in medical robotics, this support builds on our confidence in a new, less invasive solution for open surgery, a significant market that can benefit from the smallest wristed microinstruments,” said Mark Toland, CEO of MMI. “Our Symani Surgical System is uniquely positioned to expand patient access to care by accelerating the number of surgeons able to perform complex, delicate procedures.

“With the support of our investors, we will continue to advance our technology through a growing body of clinical evidence and expanded hospital partnerships.”

Editor’s Note: This article was syndicated from The Robot Report’s sister site MassDevice. 

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The Mako robotic-assisted surgery system. | Source: Stryker

Stryker Corp. has announced plans to showcase new joint-replacement technology and updates to its Mako surgical robotic platform.

This week, the orthopedic giant is displaying new advances like myMako and Triathlon Hinge at AAOS in San Francisco.

Stryker said in a release that it wants to extend a surgeon’s Mako SmartRobotics experience in and beyond the operating room. To execute this, it developed the myMako app for Apple Vision Pro and iPhone. When used on Apple Vision Pro, myMako allows surgeons to visualize and review patients’ Mako surgical plans anytime, anywhere.

The Mahwah, N.J.-based company called the update to its robot-assisted surgical system “a brilliant, immersive visual experience.” Stryker said it plans to continue developing Mako’s capabilities this year.

About a year ago, Stryker suggested that the robotic platform would have significant application expansions in 2024. The company said it expected a Mako Spine launch in the second half of 2024, with Mako Shoulder out by the end of 2024. Stryker also launched Mako Total Knee 2.0 in March 2023 and rolled out a direct-to-patient marketing campaign in August 2023.

Another Mako update comes in the form of the company’s Direct Anterior Reconstructive Technology (DART). Stryker said it aims to reduce intra-operative fluoroscopy in certain hip-replacement procedures.

Mako SmartRobotics, as part of the DART ecosystem, demonstrated accuracy in surgical planning for total hip arthroplasty without the use of fluoroscopy, the company said.

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Stryker shows other developments

Stryker plans to unveil Triathlon Hinge, the latest release in its Triathlon brand. The company called it a “significant advancement in the continuum of care for revision patients, especially rings true in complex cases involving bone loss or soft-tissue challenges.”

Triathlon Hinge builds on the versatility of the Triathlon Revision Baseplate, claimed Stryker. It features multiple intraoperative and post-operative revision knee-implant options. The company said this allows for seamless conversion to any of its revision procedures.

According to the company, Triathlon Hinge reduces the procedural steps of a Triathlon revision-to-Hinge conversion during surgery. It offers a streamlined workflow and simplified instrumentation, addressing common revision challenges and providing surgical efficiency.

“Building on the legacy of the Triathlon brand, the Triathlon Hinge is a testament to our dedication to surgical excellence and innovation,” stated Lisa Kloes, vice president and general manager of Stryker’s Knees business. “Our goal has been to simplify revision, and we are excited to see how this innovation will impact our surgeons and how it will help their patients get back to the things they love.”

Editor’s note: This article was syndicated from The Robot Report sibling site MassDevice. 

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The TMINI robotic surgical system features a wireless handpiece that assists surgeons in performing total knee replacements. | Source: THINK Surgical

THINK Surgical Inc. has announced two new collaborations involving surgical robotics and implants for total knee arthroplasty, or TKA.

The company signed deals with Maxx Orthopedics and b-ONE Ortho Corp. over the past week. These deals came just days after THINK Surgical announced a partnership with Waldemar Link on the same front.

First, in collaboration with Maxx, THINK Surgical plans to add Maxx’s implants to its TMINI miniature surgical robotic system. The deal brings the Freedom knee system for TKA to THINK Surgical’s ID-HUB.

ID-HUB serves as a proprietary database of implant modules for use with TMINI. The database already includes five implant systems from other manufacturers, including the one added from Link this week.

THINK Surgical also added b-ONE’s implants, including the Mobio total knee system.

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THINK Surgical makes flexibility a priority with TMINI

TMINI received clearance from the U.S. Food and Drug Administration in May 2023. The system includes a wireless, robotic handpiece that assists surgeons in performing total knee replacements.

Following a CT-based, three-dimensional surgical plan, the TMINI robotic handpiece automatically compensates for the surgeon’s hand movements to locate bone pins along precisely defined planes. Cutting guides are then connected to the bone pins for accurate bone resection, explained THINK Surgical.

The Fremont, Calif.-based company said that adding more implants to the database will enhance the customers’ options when using TMINI.

“We are delighted to welcome Maxx Orthopedics to the TMINI platform,” stated Stuart Simpson, president and CEO of THINK Surgical. “Their commitment to delivering creative and efficient solutions to customers complements THINK Surgical’s mission to provide customers with greater choice in patient treatment options.”

He also commented on the b-ONE partnership with THINK Surgical.

“b-ONEs’ commitment to improving the experience of both patients and surgeons through innovative technologies aligns well with our value proposition for the TMINI system,” Simpson said. “We look forward to providing customers further choice in patient treatment through our collaboration.”

TPLAN software helps surgeons create individualized plans 

Along with the TMINI system, THINK Surgical offers TPLAN, a software platform that assists surgeons in creating individualized three-dimensional surgical plans from patient CT scans. 

The software converts a patient’s CT scans into three-dimensional surface models of the bones. The surgeon then uses the TPLAN workstation to select an implant. Using displayed axes of the bones and anatomical landmarks, the surgeon then places the chosen implant components in optimal positions. 

The surgeon determines the positions for fit and alignment with the patient’s anatomy. Before surgery, TPLAN creates a pre-operative surgical plan based on the surgeon’s choices. 

Editor’s note: This article was syndicated from The Robot Report‘s sibling site MassDevice.

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CMR Surgical’s Versius surgical robotics system in action. | Source: CMR Surgical

CMR Surgical Ltd. yesterday announced that it has launched vLimeLite, an integrated fluorescence imaging system that works with its Versius Plus surgical robot. It is intended to help surgeons perform visual assessment of blood flow, vessels, and related tissue perfusion, as well as biliary anatomy, it said.

vLimeLight enables visualization of ICG (Indocyanine green) and offers options for viewing mode, asserted the Cambridge, U.K.-based company. Surgeons can choose overlay in greyscale or overlay in full color, and they can choose green or cyan for ICG color. 

“With 3D HD visualization, surgeons already have a fantastic view of their operating field at our Versius console,” said Supratim Bose, CEO of CMR Surgical. “But now, with vLimeLite, they can see beyond what the eye can see, allowing them to clearly visualize critical anatomy during their operations.”

“This is the most significant update of Versius since it launched back in 2019,” he added in a release. “We have listened to the needs of surgeons, and I’m delighted that we have been able to give them what they want — a best-in-class ICG product that we know will make a real difference for their patients.”

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CMR says it can help surgeons see the invisible 

Versius Plus is the first CE-marked surgical robot to offer this type of integrated ICG system, claimed CMR Surgical. The company also said it marks the first in a series of product releases planned for 2024.

“I think what is really special is the overlay mode option, which means Versius surgeons will be able to use our integrated ICG system while continuing to view in full color with the same video quality,” stated Mark Slack, co-founder and chief medical officer of CMR Surgical. “vLimeLite truly allows surgeons to see what was once invisible to them.”

Versius is designed to fit into most operating rooms and easily integrate into existing workflows, CMR Surgical explained. The system combines a portable and modular form factor for minimal access surgery (MAS). It also includes small, fully wristed instruments; a variety of ergonomic working positions; and an open surgeon console, as well as data collection for continual learning, the company noted.

Gloucestershire Royal Hospitals NHS Trust in the U.K. is the first hospital to install vLimeLite. Its upper GI team plans to begin cases with the system next month.

CMR Surgical gears up for another year of growth 

Boes recently spoke about CMR’s plans. He said the surgical robotics company is set for more growth. In 2023, the installed base for Versius grew 50% to 160, and its annual surgical procedure numbers grew 60% to 17,000.

This year, CMR said it is rolling out enhancements in vision technology, instrumentation, and digital products to further strengthen Versius’ value. This latest announcement seems to be only the beginning of the company’s plans this year. 

Bose maintained that CMR Surgical has an offering that can navigate between where Intuitive’s da Vinci is and where it will go. Just weeks ago, Intuitive announced that it is seeking FDA clearance for its next-gen da Vinci 5.

Editor’s note: This article was syndicated from MassDevice, a sibling site to The Robot Report.

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A screen grab from a NASA broadcast shows a Northrop Grumman Cygnus cargo spacecraft on its way to the International Space Station on Jan. 30, 2024 with the spaceMIRA from Virtual Incision onboard. | Source: NASA

Virtual Incision’s MIRA surgical robot system has made it to the International Space Station (ISS).

Lincoln, Nebraska–based Virtual Incision received a grant in 2022 for the MIRA platform to be used in a technology demonstration aboard the ISS. The National Aeronautics and Space Administration (NASA) awarded the grant to use the miniaturized robotic-associated surgery (RAS) platform on the 2024 technology demonstration mission.

The company said its spaceMIRA device sat aboard a Northrop Grumman Cygnus cargo spacecraft carried by a SpaceX Falcon 9 rocket. It says the robot will assess the impact of zero gravity when performing simulated surgical tasks. During a portion of the experiment, the company plans for a surgeon operator at its Nebraska headquarters to remotely control the robot.

Virtual Incision believes the miniaturization of RAS could offer a breakthrough in remote robotic surgery. The company feels it could simplify workflows at the patient site. Its MIRA device offers a small form factor RAS option roughly 1,000 times lighter than existing technologies.

“As thrilling as it is to have our technology in space, we expect the impact of this research will be most notable on Earth,” said John Murphy, president and CEO of Virtual Incision. “The introduction of miniRAS has the potential to revolutionize healthcare by making every operating room robot-ready. We are taking a significant step by developing MIRA, an investigational device currently under review by the FDA. The testing with spaceMIRA will tell us more about the future potential of miniRAS as it might be applied to remote surgery applications.”

More about the Virtual Incision MIRA platform

The MIRA surgical robot. | Source: Virtual Incision

MIRA includes a small, self-contained surgical device inserted through a single midline umbilical incision in the patient’s abdomen. It allows for complex, multi-quadrant abdominal surgeries. The system also uses existing minimally invasive tools and techniques that are familiar to surgeons. Altogether, MIRA weighs about two pounds.

The platform received IDE approval in October 2020, followed by approval for an IDE supplement in April. Virtual Incision submitted MIRA to the FDA for de novo review in May 2023.

In November 2021, Virtual Incision completed a $46 million Series C financing round to support the robotic surgery platform. Virtual Incision then raised $30 million more in September 2023.

“When we started this work at the University of Nebraska, we shared a collective vision that miniRAS could make robotic-assisted surgery available to any patient, any time, anywhere,” said Shane Farritor, co-founder and chief technology officer at Virtual Incision and professor of mechanical engineering at the University of Nebraska. “Exploring the use of miniRAS in extreme environments helps our teams understand how we can remove barriers for patients.”

The rocket that carried MIRA to the ISS also carried GITAI’s latest robotic system, S2. S2 is the Torrance, Calif.-based company’s dual-armed robotic system. Now that it has been delivered, the ISS crew will mount S2 on the Nanoracks Bishop Airlock, and the robot conduct an external demonstration of in-space servicing, assembling, and manufacturing (ISAM).

NASA broadcasted the launch of the spacecraft carrying MIRA. Watch here:

Editor’s Note: This article was syndicated from our sister site MassDevice.

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Lifeward, formerly ReWalk Robotics, offers a portfolio of exoskeletons for those with spinal cord injuries, brain injuries, multiple sclerosis, and more. | Source: Lifeward

ReWalk Robotics yesterday unveiled new corporate branding to officially begin operating as “Lifeward.” Beginning today, the company’s shares begin trading under the “LFWD” ticker on the Nasdaq Stock Market.

Lifeward has developed wearable systems for rehabilitation, recovery, and more to address physical limitations or disability. Its offerings include the ReWalk Personal Exoskeleton, ReStore Exo-Suit, and MyoCycle FES systems.

Founded in 2001, the company has offices in Marlborough, Mass.; Berlin; and Yokneam Illit, Israel.

Lifeward pivots following AlterG acquisition

The branding change follows the August acquisition of AlterG. Fremont, Calif.-based AlterG provides “anti-gravity” systems for use in physical and neurological rehabilitation. The transaction added its current and future product lines to ReWalk’s portfolio of neurorehabilitation products. 

Lifeward also said it expects AlterG to significantly expand its customer-facing capabilities and advance future growth opportunities.

“With the recent addition of innovative solutions like the AlterG Anti-Gravity systems to our portfolio, we have surpassed the vision of our original name,” stated Larry Jasinski, CEO of Lifeward. “The transformation of ReWalk Robotics into Lifeward speaks to the broader goal of the company to be the driving force to elevate the standard of care in overcoming physical limitations and disabilities to empower individuals to do what they love.”

Chief Sales Officer Charles Remsberg added that the newly combined commercial team now represents the company‘s full portfolio.

“We believe this will allow us to drive growth for our business through better support of our customers across the rehabilitation spectrum,” he said. “We have a portfolio of innovative solutions designed to assist individuals in achieving their goals through improved functional and health outcomes – in the clinic as well as in the community.”

ReWalk solidified Medicare coverage

In November 2023, then-ReWalk Robotics announced that the Centers for Medicare & Medicaid Services (CMS) finalized a rule benefitting its exoskeleton technology. 

Earlier in 2023, CMS released a proposal to establish a new regulatory definition of “brace” that could allow people to gain faster access to systems like Lifeward’s. The rule was finalized in November and went into effect at the beginning of 2024.

In it, CMS said the exoskeleton changes can expedite coverage and payment for newer technology and powered devices. In particular, it could help those with disabilities associated with muscular and/or neural conditions. 

Editor’s note: This article was syndicated from MassDevice, a sibling site to The Robot Report.

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The da Vinci SP surgical robot system. | Source: Intuitive Surgical

Intuitive Surgical said today that it has received CE mark certification for its da Vinci SP surgical robot. The Sunnyvale, Calif.-based company’s single-port system joins its existing X and Xi surgical ecosystem in Europe.

Beginning with urology and transoral otolaryngology procedures, European clinicians can use the robot for additional procedures over time, including endoscopic abdominopelvic, thoracoscopic, transanal colorectal, and breast surgeries.

“Surgeons in Europe have long been at the forefront of robotic-assisted surgery and led the adoption of innovative care that offers meaningful patient benefits,” said Dirk Barten, senior vice president and general manager of Intuitive Europe, on LinkedIn. “With the introduction of the da Vinci SP system, Intuitive continues to provide the latest technology to surgeons and hospitals across Europe.”

The announcement followed Intuitive Surgical’s fourth-quarter earnings call, which mentioned that the company has submitted its next-generation da Vinci 5 multiport surgical robot to the U.S. Food and Drug Administration (FDA) for clearance.

da Vinci SP offers precision, says Intuitive Surgical

Intuitive Surgical claimed that da Vinci SP gives surgeons the ability to deliver robotic-assisted surgery through a single port, opening the door to “the next era of surgical innovation.”

The surgical system features three multi-jointed, wristed instruments and a fully wristed 3D high-definition camera. The instruments and camera emerge through a single cannula and triangulate around the target anatomy at the distal tip. This helps to avoid external instrument collisions that can occur in narrow surgical workspaces, explained Intuitive Surgical.

The da Vinci SP’s patient cart design adds to instruments optimized for single-port surgery. The cart provides 360° of anatomical access, Intuitive Surgical noted.

Its single-arm design eliminates the possibility of external collisions and arm clashing, said the company. Through one port, the system allows clinicians to reach anatomy in all four quadrants of the abdomen without redocking.

The system also offers advanced vision to perform procedures with a range of complexity. da Vinci SP’s flexible endoscope allows visualization above, below, and around anatomy during a procedure, according to Intuitive Surgical.

Surgical innovators to speak at the Robotics Summit

The 2024 Robotics Summit & Expo, the world’s leading robotics development event, will include the Healthcare Robotics and Engineering Forum track. Speakers from Asensus Surgical, AiM Medical Robotics, Medtronic, and more will share insights into the latest innovations in the field of surgical robotics.

The event will take place at the Boston Convention and Exhibition Center on May 1-2. Register now to attend

Editor’s note: This article was syndicated from MassDevice, a sibling site to The Robot Report.

Learn from Agility Robotics, Amazon, Disney, Teradyne and many more.

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Senhance is designed to keep time and cost per procedure down. Source: Asensus Surgical

Asensus Surgical Inc. today announced that Nagoya University Hospital in Japan agreed last month to lease its Senhance surgical robot. This is the first pediatric installation in Japan and the fourth globally for Senhance in 2023, said the company.

“The Senhance System is specifically equipped to meet the demands of pediatric surgery, and we are excited to work with Nagoya University Hospital,” said Anthony Fernando, president and CEO of Asensus Surgical, in a release.

“With its specialized instrumentation and advanced clinical intelligence, the system offers a unique advantage for pediatric patients, reducing invasiveness and increasing precision in a way that sets it apart,” he said. “Our experience in Europe and the U.S. has shown success in various pediatric procedures, and we’re eager to extend these benefits in Japan.”

Asensus develops Senhance, LUNA to improve outcomes

Asensus Surgical claimed that its combination of machine vision, augmented intelligence, and deep-learning capabilities could improve healthcare outcomes. The company designed Senhance for use in general laparoscopic and laparoscopic gynecological procedures.

It won clearance from the U.S. Food and Drug Administration (FDA) in 2017. Since then, Asensus has secured expanded indications, deals with Google and Nvidia, and hospital placements around the world.

Nagoya University Hospital, Japan, initiated a Senhance Surgical System dedicated to pediatric procedures. Source: Asensus Surgical

Senhance became the first digital laparoscopic surgery system for children when the FDA cleared its pediatric indication in March, according to Asensus.

While the system encountered a recall because of “unintended movement,” Senhance is currently available in the U.S., EU, Japan, Russia, and other countries.

Asensus added that it has built on digital laparoscopy and the Senhance Surgical System to develop LUNA, a next-generation robot whose Intelligent Surgical Unit is designed to increase surgeon control and reduce surgical variability. It recently conducted an in vivo lab evaluation of LUNA.

Fourth deployment in Japan aimed at children

The Nagoya University Hospital deployment marked the continued expansion for Asensus in Japan. Over the past year or so, company has placed Senhance systems at Kashiwa and Kitakyushu General Hospital. In addition, Saiseikai Shiga Hospital in Ritto, Japan, agreed to lease a surgical robot.

“The Senhance System provides a valuable solution for pediatric surgery,” stated Dr. Hiroo Uchida of the Department of Pediatric Surgery at Nagoya University Hospital. “Designed with smaller patients in mind, the reusable 3 mm [0.11 in.] instruments offer a distinct advantage.”

“Having our experience in laparoscopic surgery, we find the system very adaptable, such as instinctive camera control and haptic feedback with crucial safety features,” he said. “In addition, we believe the system offers economic value. This represents a significant step forward aligning with our goal of providing the best care for our young patients.”

Editor’s note: This article first appeared on MassDevice, a sibling site to The Robot Report.

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Source: EndoQuest

EndoQuest Robotics Inc. and Omnivision have partnered to integrate Omnivision’s CameraCubeChip into EndoQuest’s surgical robotic system.

Santa Clara, Calif.-based Omnivision develops semiconductor systems, including advanced digital imaging and touch display technology.

Houston-based EndoQuest designed its system to address unmet needs in gastrointestinal and other endoluminal surgeries. The company said its proprietary technology navigates within the body’s lumina spaces such as the intestine. This provides the precision and flexibility for minimally invasive interventions, which can improve patient outcomes, it said.

EndoQuest added that its platform allows therapeutic endoscopists and surgeons to operate through a trans-oral or trans-anal approach. Last month, the company raised $42 million. Last week, the U.S. Food and Drug Administration’s Safer Technologies Program (STeP) accepted the surgical robotic system.

Omnivision to enable clearer surgical visualization

Omnivision designed the CameraCubeChip visualization system with its PureCel Plus-S pixel technology.

PureCel Plus-S enables “high full-well capacity, zero blooming and lower power consumption with crisp, clear, life-like images,” said Tehzeeb Gunja, director of medical marketing at Omnivision. He added that the compact, medical-grade offering could take patient care and surgical visualization “to the next level.”

“We are excited to be able to incorporate Omnivision’s market-leading sensor technology into the visualization component of our first-of-its-kind platform,” said Kurt Azarbarzin, CEO of EndoQuest Robotics, in a release. “We recognize that advanced imaging is essential to enhancing physician capabilities, especially inside the lumen of the gastrointestinal (GI) tract. Omnivision’s newest technology is ideal for our flexible robotic system.”

EndoQuest expects STeP to accelerate access

STeP provides a streamlined development and market review process for eligible medical devices with the goal of accelerating patient access without compromising safety and efficacy. The FDA launched STeP in 2021, modeling the program on its breakthrough devices designation program.

STeP covers devices that could improve the safety of treatments or diagnostics. They must be designed to treat underlying diseases or conditions considered less serious than those treated or diagnosed by devices eligible for breakthrough designation.

“We believe that our unique robotic platform will enhance physician control, precision, and efficiency, enabling safer and more effective minimally invasive treatments,” stated Azarbarzin. “We look forward to working with the FDA to bring the Flexible Robotic System to market and provide physicians and patients a new, scar-free approach for a wide variety of medical conditions and procedures.”

Editor’s note: This article was syndicated from MassDevice, a sibling site to The Robot Report.

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The Luna surgical robotics platform. Source: Asensus Surgical

Asensus Surgical announced Friday that it conducted an in vivo lab evaluation of its next-generation Luna surgical robot.

This evaluation marks the latest milestone for the company’s new system over the past year. Asensus first unveiled the next-generation robot in February of last year. The integrated digital surgery solution features a next-generation surgical platform and instruments, plus real-time intraoperative clinical intelligence. Its final component, a secure cloud platform, applies machine learning to deliver clinical insights.

Luna features a dextrous 5mm TrueWrist instrument range, a unique surgeon console and ergonomic benefits. It has up to four independent robotic manipulator arms for procedural flexibility, alongside a unique instrument drive system supporting various advanced instrumentation options.

In August, Asensus outlined a timeline for Luna, which includes expected FDA clearance in 2025. The company inked a manufacturing deal for the platform in November as well.

President and CEO Anthony Fernando told MassDevice in an interview that Luna enables Asensus’ vision of performance-guided surgery.

More about the latest milestone for the Asensus Luna platform

During the week of Dec. 11, 2023, Asensus hosted a surgeon lab in Research Triangle Park, North Carolina. Surgeons conducted an in vivo evaluation of Luna’s hardware, software and instruments in porcine models. The lab allowed nine participating surgeons to look at the system’s functionality through 13 different procedures. Those procedures ranged across gynecology, urology and general surgery.

Dr. Amit Trivedi, chair of the Dept. of Surgery at Pascack Valley Medical Center in New Jersey, highlighted the system’s “impressive arm range of motion and instrument dexterity” in a news release.

Trivedi said doctors saw an “essential” level of surgical precision, with the TrueWrist instruments’ strength and reliability standing out. Additionally, Trivedi highlighted the ergonomic design and easy patient access.

“The surgeon lab represents a crucial phase in the Luna development journey,” Fernando said. “The positive response from the participating surgeons reaffirms our commitment to further developing and delivering a surgical robotic system that not only meets but exceeds expectations. The insights gathered will contribute to the refinement of this late-stage engineering prototype, moving us closer to a finalized product.

“We will provide further details on Luna’s development and regulatory submission timeline during our upcoming earnings call to be scheduled to report on the fourth quarter and year-end 2023.”

Asensus provided a video of the Luna system in use:

Editor’s Note: This article was syndicated from our sister site MassDevice.

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