SS Innovations announced today that it commenced the process of applying for regulatory approvals for its surgical robot device. Fort Lauderdale, Florida-based SS Innovations plans to apply for FDA approval and CE mark for its flagship SSi Mantra device. It retained regulatory and quality compliance firm Elexes for support through the approval process. The company […]
Surgical
Integra Lifesciences expects to resume manufacturing in Boston
Integra LifeSciences (NASDAQ: IART) recently announced that it plans to resume manufacturing in its Boston facility by the end of the fourth quarter. Just two months before, Integra voluntarily recalled all tissue-related products made in Boston and distributed between March 1, 2018 and May 22, 2023. The recalled products included SurgiMend, PriMatrix, Revize and TissueMend. […]
Vicarious Surgical plans for in-human surgical robot trials next year, posts Q2 EPS miss
Vicarious Surgical (NYSE:RBOT) shares dipped this morning on second-quarter results despite a positive update on its surgical robot. Shares of RBOT fell 2.9% to $1.69 apiece in midday trading today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — stayed even. The company failed to beat Wall Street […]
Surgical visualization company Proprio raises $43M Series B
Proprio announced today that it secured $43 million in a Series B funding round that included new and existing investors. The capital infusion aids the company’s commercialization efforts for its AI-driven surgical navigation platform in the U.S. and overseas. Seattle-based Proprio designed its Paradigm surgical navigation platform to replace traditional surgical navigation technologies. Using an […]
Asensus Surgical announces $10M offering
Asensus Surgical (NYSE:ASXC) announced today that it entered into a definitive agreement for the purchase and sale of $10 million in common stock. Research Triangle Park, North Carolina-based Asensus’ offering includes just over 23.8 million shares of common stock. It also includes warrants to purchase the same amount of shares in a registered direct offering. […]
Baxter launches PerClot absorbable hemostatic powder
Baxter announced today that it launched the PerClot absorbable hemostatic powder in the U.S. PerClot, a passive, absorbable hemostatic powder, received FDA approval in May. Artivion developed the powder and transferred full ownership to Baxter as part of a sale agreement struck in July 2021. Artivion designed PerClot to control mild bleeding in specific surgical […]
Intuitive stock dips despite Street-beating Q2, increased da Vinci volumes
Intuitive Surgical shares took a hit even though its second-quarter results topped the consensus forecast. Shares of ISRG fell more than 3% to $337.17 apiece by the afternoon today — the day after Intuitive released results. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — was up slightly. […]
FDA clears MediView augmented reality visualization, navigation platform
MediView XR announced today that it received FDA 510(k) clearance for its XR90 augmented reality-based visualization and navigation platform. The company designed the surgical platform for adjunctive use in minimally invasive ultrasound and CT-guided needle-based procedures. Cleveland-based MediView said in a news release that its uses include procedures for soft tissue and bone. “This is […]
Former Medtronic exec joins ForSight Robotics as CFO
ForSight Robotics announced today that it appointed Sharon Levita as its chief financial officer (CFO), effective Sept. 1, 2023. Yokneam Illit, Israel-based ForSight Robotics said it plans for Levita to lead its strategic and financial operations. Her focuses center around driving business strategies, expanding strategic partnerships and managing financial and growth objectives. Levita offers more […]
Leading U.S. hospital begins pediatric program with Asensus surgical robot platform
Asensus Surgical (NYSE:ASXC) announced today that an unnamed leading U.S. hospital initiated a pediatric program with its Senhance platform. Research Triangle Park, North Carolina-based Asensus picked up a pediatric indication for Senhance from the FDA in March. Senhance, Asensus’ flagship offering for its Performance-Guided Surgery, is a first-of-its-kind digital laparoscopic surgical robot. It uses augmented intelligence […]
Study backs Olympus iTind for treating enlarged prostate
Olympus today announced positive study data for its minimally invasive iTind treatment for symptoms of enlarged prostate. The iTind procedure involves the placement of a temporary implanted nitinol device that reshapes the prostatic urethra. It does this without burning or cutting the prostate. Device placement can occur in an outpatient setting or physician’s office. The […]