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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 to this point. | Pictures courtesy of the businesses
Editor’s Notice: This text was syndicated from The Robotic Report’s sibling website MassDevice.
Surgical robotics has been a sizzling subject inside the medtech house, and it doesn’t seem to be it’s stopping any time quickly.
Over the course of 2024, we’ve seen all types 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 house 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 might be featured. (Be taught extra concerning the occasion and register at West.DeviceTalks.com.)
Should you want a refresher, right here’s an inventory of 10 surgical robotics corporations it is advisable to know, printed again in February. (Notice: As you’ll learn under, quite a bit 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 successful after the FDA printed a warning letter alleging violations at a Pennsylvania facility.
In accordance 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 embrace 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 offered that the required fiducial markers and inflexible affected person anatomy might be recognized on CT scans or fluoroscopy.
The FDA inspection revealed that the gadgets “are adulterated,” or not in conformity with present good manufacturing apply necessities. Particularly, the FDA discovered a failure to submit a report back to the FDA no later than 30 calendar days after the agency acquired or in any other case turned conscious of data that moderately advised that the gadget in query might have brought on or contributed to a demise or critical damage.
Globus Medical issued an announcement saying “We’re assured that we’ve got the information 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 house with FDA clearance for its next-generation robotic this 12 months.
In March, the corporate received FDA 510(okay) 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 embrace up to date surgeon controllers and highly effective vibration and tremor controls, next-generation 3D show and picture processing capabilities, and Power Suggestions know-how, amongst different enhancements.
Shortly after selecting up FDA clearance, firm officers outlined their launch plans for the brand new robotic. 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 may educate different gadget builders. And right here’s extra concerning 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 house when it agreed to be acquired by Karl Storz in June for 35¢ per share in money.
Following some scrutiny over a scarcity of disclosures, Analysis Triangle Park, North Carolina–based mostly Asensus mentioned it might file for chapter safety if shareholders didn’t approve the Karl Storz merger. Nevertheless, in August, the corporate’s shareholders gave the inexperienced gentle for the deal to go forward and the acquisition closed in August.
Karl Storz believes the deal enhances its portfolio and market presence inside the surgical robotics house. The corporate significantly highlighted the continued improvement 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 large Medtronic continues to plug forward with its Hugo surgical robotic, a possible rival to da Vinci down the road. In Might, the corporate introduced the initiation of further medical research 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 varied 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 international locations exterior the U.S.
Along with the developments for Hugo, Medtronic launched its new Reside Stream operate for the Contact Surgical procedure ecosystem of digital applied sciences in July. Contact Surgical procedure Reside Stream consists of 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 hassle. In September, the corporate introduced that Dr. James Porter joined the corporate as chief medical officer of Robotic Surgical Applied sciences and Digital Applied sciences. Medtronic expects Porter to play a key position in driving give attention to 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 Might, Tiger Group and Liquidity Providers introduced the provision of all surgical robotics property from a Medrobotics plant at public sale.
They made out there all property from the corporate’s totally furnished, 40,000-square-foot plant in Raynham, Massachusetts. That included the acquisition or lease of the constructing. Belongings, together with surgical robotics platforms utilized by almost 30 hospitals world wide, had been made out there in a turnkey sale.
Medrobotics boasted an FDA-cleared, CE-marked surgical robotic platform for a number of 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 various hindrances over the previous a number of years — together with a big IP case loss — resulting in the sale of those property.
Mendaera enhances its medical robotics choices with the acquisition of Avail’s know-how
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 final November on account of lack of funding. In March, the now-shuttered firm discovered a house for its know-how.
Medical robotics startup Mendaera agreed to buy the Avail know-how 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 geared up with high-resolution cameras, monitor and sound that related events separated by ft, miles or oceans. The corporate’s cameras offered 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 Sequence B financing spherical in September. Mendaera’s platform beneath improvement consists of 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 vital damages in Auris shareholder swimsuit
A Delaware choose dominated in September that Johnson & Johnson should pay $1 billion in damages to Auris Well being shareholders.
The ruling claimed that J&J breached its settlement to accumulate Auris, which went by for $3.4 billion in February 2019. The deal additionally included as much as an extra $2.35 billion in funds to shareholders based mostly on varied milestones.
J&J didn’t have the swimsuit dismissed in 2021, resulting in a call from Vice Chancellor Lori Will of the Delaware Court docket of Chancery. Will dominated that J&J breached the settlement and didn’t assist the acquired iPlatform know-how. In accordance with the report, this may 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 choose deemed that J&J declined to place assets towards advancing iPlatform and as an alternative pitted it in opposition to its personal Verb gadget that it developed in partnership with Google sibling firm Verily.
In accordance with Reuters, J&J mentioned it disagrees with the ruling and is contemplating an enchantment. The corporate additionally mentioned this ruling has no bearing on its present robotics program, which incorporates the much-anticipated Ottava system. J&J stays on observe 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 up to date platform to allow using its Velys robotic in backbone procedures.
Sony desires a stake within the surgical robotics market
Sony developed a microsurgery help robotic that’s able to automated surgical instrument trade and precision management. | Supply: Sony
Sony put its hat within the surgical robotics ring, unveiling its microsurgery help robotic in Might.
The Tokyo-based firm mentioned its microsurgery help robotic is able to automated surgical instrument trade and precision management. It developed the robotic to help in microsurgical procedures through the use of a microscope to work on extraordinarily small tissues, corresponding to veins and nerves. The system tracks the actions of a surgeon’s fingers 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 accordance with the corporate, the system addresses sensible challenges in typical surgical assistant robotics, corresponding to interruptions and delays attributable to manually exchanging surgical devices. Sony’s R&D crew developed the system to permit for the automated trade of components by 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 few 12 months in the past, Stryker advised that the robotic platform would have vital utility expansions in 2024. It mentioned it anticipated a Mako Backbone launch within the second half of 2024, with Mako Shoulder out by the top of 2024. Each launches have but to begin forward of the ultimate three months of 2024, although.
Stryker additionally launched Mako Complete Knee 2.0 in March 2023 and rolled out a direct-to-patient advertising marketing campaign in August 2023.
This 12 months, the corporate mentioned it desires to increase a surgeon’s Mako SmartRobotics expertise in and past the working room. To execute this, it introduced the myMako app for Apple Imaginative and prescient Professional 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 “an excellent, immersive visible expertise.” It marks the newest 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 know-how (DART). Stryker goals to cut back intra-operative fluoroscopy in direct anterior hip alternative procedures. Mako SmartRobotics, as a part of the DART ecosystem, demonstrated accuracy in surgical planning for complete hip arthroplasty with out using fluoroscopy.
Suppose Surgical inks numerous collaborations for its surgical robotics platform
Suppose Surgical’s TMINI miniature robotic system. | Supply: Suppose Surgical
Fremont, California–based mostly Suppose Surgical develops the TMINI system, which acquired FDA clearance in Might 2023. TMINI incorporates a wi-fi, robotic handpiece. It assists surgeons in performing complete knee alternative.
In June, the corporate made maybe its most noteworthy deal when it entered right into a restricted distribution settlement with Zimmer Biomet. Dr. Nitin Goyal, Zimmer Biomet’s chief science, know-how, and innovation officer, mentioned on the time that the deal made the corporate the primary to supply two complementary robotic methods for surgeons trying to incorporate robotic help whereas performing a knee alternative. (Zimmer Biomet additionally gives the flagship Rosa platform. Rosa, which lately expanded into shoulder alternative, has 4 functions, together with the knee.)
The collaboration bore fruit in September, when the FDA cleared the miniature surgical robotic to be used with the orthopedic large’s Customized Knee System. Clearance makes Suppose 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.
Suppose 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 brand new software program in July. The corporate has since added various implant choices to its system. That features collaborations with Maxx Orthopedics, b-ONE Ortho and Signature Orthopaedics.
