Medtronic today announced FDA approval of its Percept RC deep brain stimulation system, the latest member of its Percept line of DBS devices. The medtech giant describes the Percept RC as the first DBS sensing-enable rechargeable device. In a presentation at the J.P. Morgan Healthcare Conference earlier today, CEO Geoff Martha called it a “game-changing” […]
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LivaNova to wind down advanced circulatory support unit, focus on cardiopulmonary, neuromod
LivaNova announced today that it intends to begin winding down its advanced circulatory support (ACS) business unit. The orderly wind-down is part of an effort to focus on the company’s core cardiopulmonary (CP) and neuromodulation units. ACS generated approximately just 4% of LivaNova’s net revenue for the nine months ended Sept. 30, 2023. The company […]
FDA clears next-gen handheld ultrasound from Butterfly Network
Butterfly Network (NYSE:BFLY) announced today that it received FDA clearance for its next-generation handheld ultrasound system. BFLY shares were up more than 23% to $1.25 apiece on the news. MassDevice‘s MedTech 100 Index was up more than 1%. The Butterfly iQ3 point-of-care ultrasound (POCUS) system marks the third iteration of the company’s technology. Burlington, Massachusetts- […]
Boston Scientific to acquire Axonics for $3.7B
Boston Scientific announced today that it agreed to acquire Axonics (Nasdaq:AXNX) in a deal worth approximately $3.7 billion. Shares of AXNX skyrocketed before the market opened today, rising 21.1% to $69.72 apiece. Shares of BSX stayed even. Marlborough, Massachusetts-based Boston Scientific priced the acquisition at $71 in cash per share. It amounts to an equity […]
Asensus Surgical shows off its next-gen robot to surgeons
Asensus Surgical (NYSE:ASXC) announced today that it conducted an in vivo lab evaluation of its next-generation Luna surgical robot. This evaluation marks the latest milestone for the company’s new system over the past year. Asensus first unveiled the next-generation robot in February of last year. The integrated digital surgery solution features a next-generation surgical platform […]
Endotronix submits pulmonary artery sensor for FDA premarket approval
Endotronix announced today that it submitted a premarket approval (PMA) application to the FDA for its Cordella system. Cordella, a pulmonary artery (PA) sensor system, enables proactive, data-driven heart failure (HF) management. It engages patients, reduces and prevents congestion and improves outcomes. The Cordella system delivers proactive PA pressure data and non-invasive vital health data […]
Medtronic wins CE mark for next-gen Micra leadless pacemakers
Medtronic announced today that it received CE mark approval for its next-generation Micra AV2 and Micra VR2 miniature, leadless pacemakers. CE mark follows FDA approval for both devices in May of last year. The pacemakers — which Medtronic labels as the world’s smallest — provide longer battery life and easier programming than earlier versions. Micra […]
Stanford Biodesign co-founder joins Sofinnova Partners
Sofinnova Partners — a prominent life sciences venture capital firm based in Paris, London, and Milan — has added Stanford Biodesign co-founder and director Dr. Joshua Makower as an advisory venture partner. It’s been 23 years since Makower co-founded Stanford Biodesign alongside Dr. Paul Yock. They were instrumental in devising “The Biodesign Process” — used […]
Nanowear wins FDA nod for AI-enabled wearable blood pressure monitor
Nanowear announced today that its SimpleSense nanotechnology-enabled wearable and software platform received FDA 510(k) clearance. The AI-enabled noninvasive, cuffless, continuous blood pressure monitor and diagnostic offers a tool in the diagnostic management of hypertension. It adds to the wearable platform’s previously cleared cardiopulmonary diagnostics. The FDA cleared it as software as a medical device (SaMD). […]
CVRx is one of the best performing stocks out of Minnesota
CVRx (Nasdaq:CVRX) reached near the top of a list of Minnesota S&P 500 companies with best-performing stocks. With a 71% return in 2023, CVRx was No. 4 among the Minnesota “Fantastic Four” stocks, according to an analysis in the Star Tribune of Minneapolis. For comparison, the S&P 500 was up 24%. The maker of the […]
Nalu Medical raises $65M for neurostim tech
Nalu Medical announced today that it closed a $65 million equity financing to support its minimally invasive neurostimulation product. Carlsbad, California–based Nalu had its round led by new investor Novo Holdings. All existing significant investors — including Gilde Healthcare, MVM Partners, Endeavor Vision, Decheng Capital, Longitude Capital, Advent Life Sciences, Pura Vida and Aperture Venture […]