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The Intuitive da Vinci 5 (high left), Sony microsurgery help robotic (high proper), Stryker Mako (backside left) and Globus Medical ExcelsiusGPS (backside proper) are all featured within the high surgical robotics tales of 2024 thus far. | Photographs courtesy of the businesses
Editor’s Word: This text was syndicated from The Robotic Report’s sibling website MassDevice.
Surgical robotics has been a sizzling matter inside the medtech area, and it doesn’t seem to be it’s stopping any time quickly.
Over the course of 2024, we’ve seen every kind of tales throughout surgical robotics. From regulatory nods and product launches to recollects and warning letters, plus some M&A in between, the surgical robotics area has been lively over the previous 9 months.
At DeviceTalks West, co-located with RoboBusiness, in Santa Clara, California, Oct. 16-17, a variety of robotic applied sciences will likely be featured. (Study extra in regards to the occasion and register at West.DeviceTalks.com.)
If you happen to want a refresher, here’s a list of 10 surgical robotics companies you need to know, printed again in February. (Word: As you’ll learn beneath, lots has occurred since then.)
Forward of DeviceTalks West, let’s check out the surgical robotics tales which have garnered MassDevice’s readers’ consideration in 2024:
Globus Medical faces FDA warning letter over surgical robotics platform
The Excelsius GPS system. | Supply: Globus Medical
In August, shares of Globus Medical took a hit after the FDA published a warning letter alleging violations at a Pennsylvania facility.
In line with the FDA letter, the inspection centered across the firm’s Excelsius GPS surgical robotic and related interbody backbone and cranial modules. Excelsius GPS’ makes use of embody finding anatomical constructions and for the spatial positioning and orientation of an instrument holder or information tube for use by surgeons for navigating and/or guiding appropriate surgical devices in open or percutaneous procedures supplied that the required fiducial markers and inflexible affected person anatomy may be recognized on CT scans or fluoroscopy.
The FDA inspection revealed that the gadgets “are adulterated,” or not in conformity with present good manufacturing follow necessities. Particularly, the FDA discovered a failure to submit a report back to the FDA no later than 30 calendar days after the agency obtained or in any other case grew to become conscious of data that moderately advised that the gadget in query could have triggered or contributed to a loss of life or severe harm.
Globus Medical issued an announcement saying “We’re assured that we’ve got the info and documentation to assist swift decision on this matter.”
Intuitive particulars da Vinci 5 launch plans following FDA nod
The Intuitive Surgical da Vinci 5 tower. | Supply: Intuitive Surgical
Intuitive, the longtime chief in surgical robotics, additional cemented its place atop the area with FDA clearance for its next-generation robotic this 12 months.
In March, the corporate won FDA 510(k) clearance for the da Vinci 5, including it to a portfolio that options the multiport X and Xi methods and the single-port SP. The corporate additionally has Ion, its robotic-assisted platform for minimally invasive biopsy within the lung.
New options of the da Vinci 5 embody up to date surgeon controllers and highly effective vibration and tremor controls, next-generation 3D show and picture processing capabilities, and Pressure Suggestions expertise, amongst different enhancements.
Shortly after selecting up FDA clearance, company officials outlined their launch plans for the new robot. Intuitive expects its restricted rollout to proceed into 2025 to optimize manufacturing and provide chain forward of a full launch. (Medical Design & Outsourcing explored what the da Vinci 5 launch plans could teach other device developers. And here’s more about the da Vinci 5’s design.)
Karl Storz acquires Asensus Surgical
The Luna surgical robotics platform. | Supply: Asensus Surgical
Asensus, previously TransEnterix, made waves within the surgical robotics area when it agreed to be acquired by Karl Storz in June for 35¢ per share in money.
Following some scrutiny over a lack of disclosures, Analysis Triangle Park, North Carolina–primarily based Asensus said it would file for bankruptcy protection if shareholders didn’t approve the Karl Storz merger. Nevertheless, in August, the corporate’s shareholders gave the green light for the deal to go ahead and the acquisition closed in August.
Karl Storz believes the deal enhances its portfolio and market presence inside the surgical robotics area. The corporate significantly highlighted the continuing growth of Asensus Surgical’s next-generation Luna platform.
Asensus additionally develops the Senhance surgical robotic platform. It additionally develops the Clever Surgical Unit (ISU) for Senhance. Asensus designed ISU as a real-time intraoperative surgical picture analytics platform. It leverages augmented intelligence to assist scale back surgical variability.
Medtronic advances its surgical robotics choices
The Hugo robotic surgical procedure system. | Supply: Medtronic
Medtech big Medtronic continues to plug forward with its Hugo surgical robotic, a possible rival to da Vinci down the road. In Could, the corporate introduced the initiation of additional clinical studies for Hugo to develop its indications to hernia and gynecology.
The research are underway to assist a deliberate submission to the FDA for the Hugo system. Hugo, first unveiled in September 2019, is a modular, multi-quadrant platform designed for numerous surgical procedures with wristed devices, 3D visualization and surgical video seize choices in Contact Surgical procedure Enterprise. It already has set up bases rising throughout 25 nations exterior the U.S.
Along with the developments for Hugo, Medtronic introduced its new Live Stream function for the Touch Surgery ecosystem of digital technologies in July. Contact Surgical procedure Dwell Stream contains 14 new AI algorithms designed to reinforce its digital capabilities inside post-operative evaluation. The algorithms ship AI-powered surgical insights for laparoscopic and robotic-assisted surgical procedure.
As the corporate pushes forward in surgical robotics, it has a brand new determine serving to to steer the trouble. In September, the corporate introduced that Dr. James Porter joined the company as chief medical officer of Robotic Surgical Technologies and Digital Technologies. Medtronic expects Porter to play a key function in driving deal with sufferers and robotic and digital innovation.
Medrobotics places its surgical robotics property up on the market
The Flex 360 robotic surgical procedure system from Medrobotics. | Supply: Tiger Group
In Could, Tiger Group and Liquidity Providers announced the availability of all surgical robotics assets from a Medrobotics plant at public sale.
They made out there all property from the corporate’s absolutely furnished, 40,000-square-foot plant in Raynham, Massachusetts. That included the acquisition or lease of the constructing. Property, together with surgical robotics platforms utilized by practically 30 hospitals world wide, had been made out there in a turnkey sale.
Medrobotics boasted an FDA-cleared, CE-marked surgical robotic platform for several years. The corporate designed its minimally invasive Flex system to entry hard-to-reach anatomy for otolaryngology, colorectal and gastroenterology procedures.
Nevertheless, the corporate hit a lot of obstacles over the previous a number of years — together with a major IP case loss — resulting in the sale of those property.
Mendaera enhances its medical robotics choices with the acquisition of Avail’s expertise
The Avail Medsystems telepresence console can beam video, audio, and knowledge to laptops and tablets. | Supply: Avail Medsystems
Avail Medsystems, an organization aiming to ascertain digital connections between medical gadget gross sales reps and working rooms, shut down last November due to lack of funding. In March, the now-shuttered firm discovered a house for its expertise.
Medical robotics startup Mendaera agreed to buy the Avail expertise and employed a few of its workers. The deal included “considerably all” of Avail’s property.
Avail’s system consisted of a 6-ft-high tower outfitted with high-resolution cameras, monitor and sound that linked events separated by toes, miles or oceans. The corporate’s cameras supplied a crisp and clear view of surgical suites. The built-in audio system enabled seamless dialog between surgeons and out of doors events engaged on a proprietary laptop computer interface.
Along with the acquisition of Avails’ property, Mendaera continued its stable exit from stealth mode by closing a $73 million Series B financing round in September. Mendaera’s platform underneath growth contains robotics, AI, real-time imaging, and digital connectivity. The corporate designed it for accessibility throughout specialties and websites, serving to to satisfy the rising demand for needle-based interventions.
Johnson & Johnson to pay important damages in Auris shareholder go well with
A Delaware judge ruled in September that Johnson & Johnson must pay $1 billion in damages to Auris Well being shareholders.
The ruling claimed that J&J breached its settlement to accumulate Auris, which went through for $3.4 billion in February 2019. The deal additionally included as much as an extra $2.35 billion in funds to shareholders primarily based on numerous milestones.
J&J failed to have the suit dismissed in 2021, resulting in a choice from Vice Chancellor Lori Will of the Delaware Courtroom of Chancery. Will dominated that J&J breached the settlement and didn’t assist the acquired iPlatform expertise. In line with the report, this is able to have led to elevated funds to Auris shareholders.
Reuters says Will’s ruling acknowledged that J&J breached the settlement “nearly instantly after closing.” The decide deemed that J&J declined to place sources towards advancing iPlatform and as an alternative pitted it towards its personal Verb gadget that it developed in partnership with Google sibling firm Verily.
In line with Reuters, J&J mentioned it disagrees with the ruling and is contemplating an attraction. The corporate additionally mentioned this ruling has no bearing on its present robotics program, which incorporates the much-anticipated Ottava system. J&J remains on track to submit the Ottava surgical robotic for FDA investigational gadget exemption (IDE) within the second half of this 12 months. In the meantime, the corporate’s DePuy Synthes unit launched an updated platform to enable the use of its Velys robot in spine procedures.
Sony needs a stake within the surgical robotics market
Sony developed a microsurgery help robotic that’s able to automated surgical instrument alternate and precision management. | Supply: Sony
Sony put its hat within the surgical robotics ring, unveiling its microsurgery assistance robot in May.
The Tokyo-based firm mentioned its microsurgery help robotic is able to automated surgical instrument alternate and precision management. It developed the robotic to help in microsurgical procedures through the use of a microscope to work on extraordinarily small tissues, similar to veins and nerves. The system tracks the actions of a surgeon’s palms and fingers utilizing a extremely delicate management gadget. Actions are then replicated on a small surgical instrument that operates equally to the motion of the human wrist.
In line with the corporate, the system addresses sensible challenges in typical surgical assistant robotics, similar to interruptions and delays brought on by manually exchanging surgical devices. Sony’s R&D crew developed the system to permit for the automated alternate of components by means of miniaturization.
Sony’s researchers hope to make use of the robotic assistant in all kinds of surgical procedures.
Stryker continues to develop the Mako platform
The Mako robotic-assisted surgical procedure system. | Supply: Stryker
A couple of 12 months in the past, Stryker suggested that the robotic platform would have significant application expansions in 2024. It mentioned it anticipated a Mako Backbone launch within the second half of 2024, with Mako Shoulder out by the tip of 2024. Each launches have but to start forward of the ultimate three months of 2024, although.
Stryker additionally launched Mako Total Knee 2.0 in March 2023 and rolled out a direct-to-patient marketing campaign in August 2023.
This 12 months, the corporate mentioned it needs to increase a surgeon’s Mako SmartRobotics expertise in and past the working room. To execute this, it announced the myMako app for Apple Vision Pro and iPhone in February. When used on Apple Imaginative and prescient Professional, myMako permits surgeons to visualise and assessment sufferers’ Mako surgical plans anytime, wherever.
The corporate calls the brand new innovation “a superb, immersive visible expertise.” It marks the most recent potential innovation for Mako, which the corporate expects to proceed increasing because the 12 months goes on.
One other Mako replace comes within the type of the corporate’s direct anterior reconstructive expertise (DART). Stryker goals to cut back intra-operative fluoroscopy in direct anterior hip substitute procedures. Mako SmartRobotics, as a part of the DART ecosystem, demonstrated accuracy in surgical planning for complete hip arthroplasty with out using fluoroscopy.
Assume Surgical inks numerous collaborations for its surgical robotics platform
Assume Surgical’s TMINI miniature robotic system. | Supply: Assume Surgical
Fremont, California–primarily based Assume Surgical develops the TMINI system, which received FDA clearance in May 2023. TMINI contains a wi-fi, robotic handpiece. It assists surgeons in performing complete knee substitute.
In June, the corporate made maybe its most noteworthy deal when it entered into a limited distribution agreement with Zimmer Biomet. Dr. Nitin Goyal, Zimmer Biomet’s chief science, expertise, and innovation officer, mentioned on the time that the deal made the corporate the primary to supply two complementary robotic methods for surgeons seeking to incorporate robotic help whereas performing a knee substitute. (Zimmer Biomet additionally presents the flagship Rosa platform. Rosa, which recently expanded into shoulder replacement, has 4 purposes, together with the knee.)
The collaboration bore fruit in September, when the FDA cleared the miniature surgical robot for use with the orthopedic giant’s Personalized Knee System. Clearance makes Assume Surgical the one firm providing a robotic system offering each an implant-exclusive choice with the Persona Knee system and an open implant platform to be used with implants from a number of different producers for complete knee arthroplasty.
Assume Surgical says it goals to supply surgical robots that assist implants from a number of producers. The Zimmer Biomet clearance follows FDA clearance for TMINI with Medacta knee methods in August, plus clearance for new software in July. The corporate has since added a lot of implant choices to its system. That features collaborations with Maxx Orthopedics, b-ONE Ortho and Signature Orthopaedics.
