SS Innovations today issued an update on the FDA approval timeline for its Mantra surgical robotic system following meetings with the agency. Earlier this year, the company completed its first interactive pre-submission meeting with the FDA for SSi Mantra. It said in a news release that it received feedback to help it proceed with a […]
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Stryker adds newly acquired products to Foot & Ankle portfolio
Stryker announced today that it added two new products to its Foot & Ankle portfolio after acquiring them from 4WEB Medical. Portage, Michigan–based Stryker recently acquired the Osteotomy Truss System (OTS) and Ankle Truss System (ATS) from 4WEB. It plans to feature both systems, plus other products, this week at the American Orthopaedic Foot & […]
Smith+Nephew launches Total Ankle patient-matched guides
Smith+Nephew announced that it launched its Total Ankle patient-matched guides for planning and performing replacement procedures. The London-based orthopedic giant engineered the guides using 3D Systems‘ VSP surgical planning workflows. It aims to provide surgeons with a predictable, efficient option for planning and performing total ankle replacement (TAR) procedures. All-in-one Total Ankle patient-matched guides help […]
Boston Scientific warns on Avvigo+ multi-modality guidance system software anomaly
Boston Scientific issued an urgent field safety notice to warn of a software anomaly that may occur with its Avvigo+ multi-modality guidance system. Avvigo+, a next-generation system, provides intravascular ultrasound (IVUS) and fractional flow reserve (FFR). It uses advanced software and hardware to provide high-quality IVUS vessel imaging and physiology experience. The system’s uses include […]
NeuroOne touts breakthrough case with neuroablation system
NeuroOne Medical Technologies (Nasdaq:NMTC) today announced a breakthrough patient procedure using its OneRF ablation system. The OneRF system picked up FDA 510(k) clearance in December 2023 for the creation of radiofrequency (RF) lesions in nervous tissue for functional neurosurgical procedures. This technology uses already-implanted sEEG electrodes to record brain activity and enable the ablation of […]
Surgical robotics veteran Dr. Fred Moll joins SS Innovations’ board
SS Innovations announced today that it appointed Dr. Frederic Moll to its board of directors, naming him vice chair. Moll, the founder of surgical robotics leader Intuitive Surgical, brings decades of experience to the board at SS Innovations. Labeled the “father of surgical robotics” by SS Innovations, he co-founded Intuitive in the 1990s and oversaw […]
J&J MedTech updates brand identity, renames five businesses
Johnson & Johnson MedTech today announced several of its medical technologies businesses will be renamed. The Ethicon, DePuy Synthes, Biosense Webster, Abiomed and Cerenovus businesses will now go by the J&J MedTech name. Johnson & Johnson said the rename is part of its updated brand and visual identity update, which was announced in September last […]
Apple introduces new sleep apnea, hearing aid features on Watch, AirPods
Apple today unveiled new sleep and hearing health features for its Apple Watch and AirPods Pro 2, expanding its health metrics offerings. The Apple Watch now offers sleep apnea notifications, utilizing the tech giant’s new breathing disturbances metric. Apple says it expects FDA authorization soon, along with approval in other geographies. The company plans to […]
Edwards expects lower EPS after layoffs, Critical Care sale
Following recent developments at Edwards Lifesciences , the company is expecting lower earnings per share in 2025 compared to its 2024 forecast. Analysts at Wells Fargo reduced their price target for the company in response to that as CEO Bernard Zovighian played down negative reactions by investors, speaking at the Wells Fargo Healthcare Conference last […]
DeepWell DTx wins FDA clearance of software development kit, with first indications for stress reduction and hypertension
DeepWell Digital Therapeutics (DTx) has won FDA 510(k) clearance of technology to be used in immersive media like video games for stress reduction and as an adjunctive treatment for high blood pressure. The digital therapeutics developer plans to make its biofeedback software development kit (SDK) available to video game developers and media companies to embed […]
Procyrion adds Silk Road Medical exec to its board
Procyrion — developer of the catheter-deployed Aortix percutaneous mechanical circulatory support device — has a new board member. Lucas Buchanan is the COO of Sunnyvale, California–based Silk Road Medical. Boston Scientific is in the process of acquiring Silk Road and its technology to prevent stroke in patients with carotid artery disease in a $1.16 billion […]
