Senseonics (NYSE:SENS) shares dipped after hours on fourth-quarter results that came in ahead of the consensus forecast. The company also reported an “imminent” submission of its latest, longest-lasting continuous glucose monitoring (CGM) technology. Shares of SENS fell 3.5% to 69¢ apiece after the market closed today. MassDevice’s MedTech 100 Index — which includes stocks of […]
Implants
Affluent Medical has positive biomimetic mitral valve data
Affluent Medical today announced positive findings in a clinical evaluation of its Epygon device for replacing mitral valves. The Aix-en-Provence, France-based company designed Epygon to replace mitral valves in those with mitral insufficiency. Epygon is the first biomimetic transcatheter mitral valve to mimic the native mitral valve and restore the natural vortex of blood flow […]
Onward wins FDA breakthrough nod for use of neurostim with brain-computer interface
Onward Medical announced today that the FDA granted breakthrough device designation for its ARC-BCI system that uses brain-computer interface (BCI) technology. ARC-BCI uses BCI technology in conjunction with ARC-IM neurostimulation. It aims to restore thought-driven lower limb mobility after spinal cord injury (SCI). The BCI system uses AI to decode brain signals and translate them […]
Medtronic asks ITC to stop Axonics’ sales of neuromod devices
Medtronic today announced that it filed a complaint to the U.S. International Trade Commission (ITC) to block the sales of certain Axonics (Nasdaq:AXNX) devices. The complaint to the ITC runs parallel to action in the U.S. District Court for the District of Delaware. Medtronic wants to block Axonics from “improperly importing and selling products that infringe […]
FDA clears sacroiliac joint fusion device from Nevro
Nevro (NYSE:NVRO) announced today that the FDA cleared its sacroiliac (SI) joint fusion device without the need to include an accompanying screw. Redwood City, California-based Nevro plans to market this device as Nevro1, without the need for the NevroFix screw. The system aims to immediately transfix the SI joint, allowing the opportunity for long-term fusion. […]
BlueWind reports first patient treated in study of neuromod for urinary incontinence
BlueWind Medical announced today that a doctor treated the first patient in the RESTORE study of its Revi iTNM device. Dr. Osvaldo Padron of Florida Urology Partners in Tampa, Florida, treated the first patient. The prospective, multi-center, open-label, post-market, randomized controlled trial aims to recruit 150 patients across up to 20 U.S. centers. BlueWind designed Revi […]
Smith+Nephew sales are up 7% as 12-point plan progresses
Smith+Nephew shares dipped today on fourth-quarter results that included nearly 7% sales growth year-over-year. Shares of SNN fell 2% to $27.97 apiece in late-afternoon trading. The London-based orthopedic giant posted sales of $1.458 million in the quarter. That marked 6.8% growth compared to the same period a year ago. Smith+Nephew says it continues to make […]
Mainstay Medical raises $125M for neurostim tech
Mainstay Medical announced an equity financing worth $125 million set to support the commercial growth of its neurostimulation technology. The company plans to put its new funds toward commercializing its ReActiv8 system in the U.S., Europe and Australia. It also has eyes on using the money for post-market clinical studies and research, plus general operations. […]
Elon Musk says first Neuralink patient can control mouse with thoughts
Reuters reports that the Elon Musk-backed Neuralink brain-computer interface (BCI) venture has positive early clinical trial results. Musk reportedly said as much in a “Spaces” event on X (the social media website previously known as Twitter and now owned by Musk). The company won a regulatory nod in May for a first-in-human implant, and in September […]
Enovis stock rises on Street-beating Q4, return to profit
Enovis shares got a boost today on fourth-quarter results that landed ahead of the consensus forecast. Shares of ENOV rose 7.4% at $64.72 apiece in mid-afternoon trading today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — ticked up 0.5%. The Wilmington, Delaware-based company — one of the […]
UroMems has positive results for first-ever female implant of smart urinary sphincter system
UroMems announced today that it successfully met the six-month primary endpoint for the first female patient implanted with UroActive. Grenoble, France-based UroMems designed its smart UroActive implant to treat stress urinary incontinence (SUI). The company says it’s the first smart, automated artificial urinary sphincter (AUS) to treat SUI. Powered by a MyoElectroMechanical system (MEMS), UroActive […]