Memic Innovative Surgery partners with VirtaMed to develop robotic surgery VR training

Hominis humanoid-shaped arms inside the virtual reality simulation [Image courtesy of VirtaMed]VirtaMed and Memic Innovative Surgery announced today that they will work together to develop virtual reality simulations for surgeons training on Memic’s Hominis surgical system.

The FDA-authorized Hominis surgical robot features small humanoid-shaped arms that include shoulder, elbow and wrist joints to provide human-level dexterity and 360-degree articulation. The surgical robotics system has an indication for use in single-site, natural orifice laparoscopic-assisted transvaginal benign gynecological procedures including benign hysterectomy.

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Medtronic performs first procedure with Hugo surgical robot in Europe

[Image from Medtronic]Medtronic (NYSE:MDT) announced today that it performed the first clinical procedure in Europe with its Hugo robotic-assisted surgery system.

Dr. Alexandre Mottrie, head of urology at OLV Hospital in Aalst, Belgium, and CEO and founder of the Belgium-based ORSI Academy for training, R&D and data analysis for improving minimally invasive surgery best practices, performed the robotic prostatectomy. Hugo received CE mark approval for urologic and gynecologic procedures in October 2021.

Read: President of Medtronic’s surgical robotics business Megan Rosengarten shares the company’s excitement as Hugo clears European regulatory milestone.

“Performing Europe’s very first procedure with the Hugo RAS system is a career highlight for me,” Mottrie said in a news release. “With more than two decades and 4,000 robotic-assisted surgery procedures under my belt, I am intimately aware of the barriers that have kept th…

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Johnson & Johnson must face former Auris Health shareholders’ fraud lawsuit

[Image from Unsplash]A Delaware judge has denied Johnson & Johnson’s motions to dismiss a fraud lawsuit filed by former shareholders of Auris Health, who alleged that J&J executives misrepresented their intentions for the robotic surgery company when they acquired it for $3.4 billion in 2019.

Acting as the representative of the former Auris shareholders, Fortis Advisors sued last year after the medtech giant released reserves related to the additional $2.35 billion in milestone payments that were part of the agreement.

J&J, its Ethicon subsidiary and top corporate officers violated the merger agreement and made false promises during negotiations, according to the lawsuit.

Vice Chancellor Lori W. Will in Delaware, in a December 13 order, allowed more than half of Fortis Advisors counts against J&J to proceed, though she dismissed claims against individual J&J executives on jurisdictional grounds.

Surgical robotics is a hot sp…

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Intuitive wins FDA clearance for robotic stapler

Intuitive (NSDQ:ISRG) announced today that it received FDA clearance for its SureForm stapler and reloads for use in surgery.

Sunnyvale, California-based Intuitive designed its fully wristed, 8 mm SureForm 30 curved-tip stapler and reloads (gray, white and blue) for use in general, thoracic, gynecologic, urologic and pediatric surgery.

Its aim is to help surgeons better visualize and reach anatomy through a combination of the 8 mm diameter instrument shaft and jaws, 120-degree cone of wristed articulation and the curved tip. As the stapler fits through the 8 mm da Vinci surgical robot instrument cannula, it allows different angles for surgeons to approach patient anatomy.

The 8mm SureForm 30 curved-tip stapler also integrates SmartFire software for optimizing staple line performance by measuring tissue compression before and during stapling.

According to a news release, the company expects to launch the 8 mm SureForm 30 stapler in the U.S. in 2022…

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Supply chain, manufacturing issues slow Medtronic’s Hugo launch, ramp-up expected next fiscal year

Medtronic’s Hugo robot-assisted surgery system [Image courtesy of Medtronic]

Medtronic (NYSE:MDT) Chairman & CEO Geoff Martha confirmed that the launch of the Hugo surgical robot platform is slightly off-schedule.

Speaking on the company’s second-quarter earnings call today, Martha said the launch of the platform, which the company has developed to challenge Intuitive Surgical in the surgical robotics space, is “not on-schedule but not off-track” at this stage.

Hugo received CE mark approval last month and the company is gearing up to conduct its FDA investigational device exemption (IDE) clinical trials in the U.S., with more on the company’s stateside efforts still to come, President of Medtronic’s surgical robotics business, Megan Rosengarten, told MDO recently.

The launch that followed is currently in what Martha called a “limited-release phase” as the c…

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Johnson & Johnson hits snag in Ottava surgical robot development

Johnson & Johnson (NYSE:JNJ) today confirmed that it experienced a “temporary setback” with its Ottava surgical robotic system.

Speaking on the company’s third-quarter earnings call, transcribed by SeekingAlpha, J&J EVP Joseph Wolk said that, while the company maintains its commitment to developing a general surgery offering with Ottava, the platform’s development timeline has been pushed back about two years due to multiple factors.

The initial expectation was to begin the verification and validation processes for Ottava in 2021, followed by enrollment in clinical trials for the device in 2022.

“We recorded a partial in-process R&D charge for $900 million in the third quarter,” Wolk said. “The accounting for this charge contemplates a first-in-human delay of approximately two years from our earlier projections of the second half of 2022, reflecting technical development challenges and COVID-19-relate…

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Intuitive responds to FDA alert on robot-assisted mastectomies

The FDA is warning patients and health care providers that some clinical studies using robotically-assisted surgical devices for mastectomies may not have the proper regulatory supervision.

The FDA said it is “aware of allegations that clinical studies are being conducted using RAS devices to perform mastectomies for the prevention or treatment of cancer without the FDA oversight required for such significant risk studies.”

The agency has cleared robotically-assisted surgical devices for use in hysterectomies, prostatectomies and colectomy based on 30-day follow-ups with patients, but cautioned that it “has not evaluated the safety or effectiveness of RAS devices for the prevention or treatment of cancer, based on cancer-related outcomes such as overall survival, recurrence, and disease-free survival.”

Get the full story on our sister site Medical Design & Outsourcing. 

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Explorer Surgical expands offerings into robotic surgery space

Explorer Surgical announced today that will expand its cloud-based digital platform into the robotic surgery space.

As a result of the foray into surgical robotics, medical robotics companies will now be able to leverage the Explorer Live digital platform and procedural playbook, video capabilities and data collection offerings to improve workflow and performance.

Chicago-based Explorer Surgical said in a news release that the Explorer Live platform offers surgical teams and medical robotics companies access to all images, PDFs and videos about the system, surgical techniques and a step-by-step workflow for each team member in the operating room, with the digital playbook customized to the clinical team’s role, procedure type and surgeon preferences.

Additionally, surgeons can broadcast in real-time to provide clinical education, remote collaboration or demonstrations to potential users, while the platform can capture video and procedural data for …

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Stryker acquires OrthoSensor and its knee surgery sensor tech

Stryker (NYSE:SYK) announced today that it has bought privately-held OrthoSensor and its Verasense intraoperative sensor tech that could further enhance the ortho giant’s Mako robots.

The financial terms of the deal were not disclosed.

Stryker officials in a news release noted that Verasense since 2011 has proved itself to be a  unique knee balancing solution in Stryker’s Triathlon knee system, providing feedback to surgeons on soft tissue. They think the sensor tech will further boost Mako surgical robotics systems, enhancing workflow through one complete data-driven feedback mechanism.

Additionally, OrthoSensor’s MotionSense remote patient monitoring wearables and mobile application combined with the OrthloLogIQ cloud-based data platform could up Stryker’s data analytics capabilities.

“Smart devices and implants will play a big role in orthopaedics and we are excited for OrthoSensor to join Stryker as we continue to innovate an…

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Intuitive Surgical sales down more than a fifth in Q2

Intuitive Surgical (NSDQ:ISRG)  posted second-quarter results today that beat Wall Street expectations — but the results still showed how much the COVID-19 pandemic has damaged sales for surgical robotics companies.

The Sunnyvale, Calif.-based robot-assisted surgery company — the dominant player in the space — reported profits of $68 million, or $0.57 per diluted share, on sales of $852 million for the three months ended June 20, 2020. The results represented a bottom-line decline of 79% and a top-line slide of 22% compared with Q2 2019.

Adjusted to exclude one-time items, earnings per share were 80¢, 17¢ ahead of The Street, where analysts were looking EPS of 63¢ on sales of $665 million.

“The surge of COVID in communities that represent our core markets, either from initial spread or secondary growth, is occurring now. Add to the significant anecdotal evidence of delayed diagnostic visits for non-COVID illness, and we expect that the recovery tal…

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Johnson & Johnson to take its time on general surgery robot

Johnson & Johnson (NYSE:JNJ)  has decided not to follow a 510(k) clearance pathway for its planned general surgery robot — with a goal to start first-in-human studies with the system by the second half of 2022.

That was one of the major pieces of information to come out of the New Brunswick, N.J.–based company’s quarterly earnings call yesterday.

Before the COVID-19 pandemic struck, the U.S., J&J had been planning some kind of robotic surgery reveal in May. The medtech giant has been working on combining technologies that came out of its previous Verb Surgical collaboration with the Alphabet (NSDQ:GOOGL) life sciences unit Verily — as well as its $3.4 billion purchase of Auris Health and its FDA-cleared Monarch platform.

Robot-assisted surgery is presently a hot area in medtech — with J&J, Medtronic and others seeking to take on Intuitive Surgical (NSDQ:ISRG), the dominant company in the space.

“We continue to be impressed …

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Smith+Nephew launches next-gen surgical robotics system

The Cori surgical system [Image courtesy of Smith+Nephew]

Competition continues to heat up in the robotic orthopedic surgery space, with Smith+Nephew (LON:SN) today announcing the launch of its next-gen Cori surgical system.

Cleared by FDA and available for both total and unicompartmental knee arthroplasty, the handheld Cori robotics platform is meant to be faster than S+N’s previous Navio system. On top of Cori, the British medtech giant is also launching its Real Intelligence suite of digital surgery solutions that are meant to improve patient engagement, pre-operative planning, digital and robotic surgery, post-operative assessment and outcomes measurement.

“The Real Intelligence brand is a statement of how Smith+Nephew thinks, innovates,and reimagines surgery,” said Skip Kiil, president of Orthopaedics for Smith+Nephew.

“The introduction of the Cori surgical system’…

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