The FDA announced today that it has designated a Boston Scientific recall of its Obsidio conformable embolic as Class I, its most serious level of recall. The Obsidio embolic is a premixed embolic agent that is delivered in a minimally invasive way through a catheter-based system to block or occlude blood flow to specific blood […]
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Viz.ai, NICO collaborate to improve intracerebral hemorrhage treatment
Viz.ai today announced a collaboration with NICO Corporation to help improve the lives of patients with intracerebral hemorrhages. Intracerebral hemorrhage (ICH) is caused by bleeding in the brain tissue and is a life-threatening type of stroke. It accounts for up to 15% of all strokes and has high morbidity and mortality rates. Viz-ai’s technology can […]
Spark Neuro names Mayo Clinic neurologist medical director
Spark Neuro announced that it appointed longtime Mayo Clinic neurologist Dr. Richard J. Caselli as its new medical director. Caselli spent 35 years at the Mayo Clinic, a leading U.S. hospital system. He brings expertise and leadership in neurology and cognitive aging to Los Angeles-based Spark Neuro. Spark Neuro develops brain health assessment services propelled […]
Allurion closes $48 million financing
Allurion (NYSE:ALUR) announced today that it closed a financing of convertible senior secured notes worth $48 million. The company entered into the financing with certain entities managed by RTW Investments. It intends to use proceeds to repay obligations under its existing term loan with Fortress Credit Corp. This reduces the company’s interest expense and increases […]
Outset Medical inks deal to expand home hemodialysis in the U.S.
Outset Medical announced today that it partnered with U.S. Renal Care to accelerate home hemodialysis in the U.S. The company entered into a multi-year agreement with U.S. Renal Care, the country’s largest privately held kidney care provider. They aim to utilize the Outset Tablo hemodialysis system as a home dialysis option in the 33 states […]
Abbott increases guidance on strong Q1 results, reports progress on Volt PFA system
Abbott shares fell this morning despite first-quarter results that came in ahead of the consensus forecast. Shares of ABT fell more than 4% to $104.75 apiece as the market opened today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — dipped by 0.2%. The Abbott Park, Illinois-based medtech […]
Ypsomed, ten23 health collab on YpsoDose patch injector
Ypsomed announced today that it entered into a partnership with ten23 health to commercialize its YpsoDose wearable injector. Burgdorf, Switzerland-based Ypsomed designed YpsoDose for the subcutaneous self-injection of large-volume doses. ten23 health, a Swiss CDMO, offers drug development, filling and device assembly expertise to contribute to the product offering. The strategic collaboration sees both parties […]
CVRx has more data supporting long-term benefits of Barostim
CVRx (Nasdaq:CVRX) announced the publication of post-market data highlighting long-term, sustained benefits with its Barostim device. Minneapolis-based CVRx published results from the BeAT-HF trial in the European Journal of Heart Failure. Data supported Barostim treatment in heart failure patients with reduced ejection fraction. Barostim delivers electrical pulses to baroreceptors in the wall of the carotid […]
Cardiawave names new CEO
French non-invasive ultrasound therapy (NIUT) device developer Cardiawave announced today it appointed Olivier Pierron as its new CEO. Levallois-Perret, France-based Cardiawave develops its Valvosoft NIUT device for the treatment of severe symptomatic calcific aortic stenosis. As CEO, Pierron holds responsibility for overseeing the deployment of Valvosoft in the European market and U.S. clinical trials. He […]
FastWave Medical wins patent for laser-IVL tech
FastWave Medical announced today that it received a fourth utility patent to strengthen the IP foundation of its IVL platform. Minneapolis-based FastWave develops laser-based intravascular lithotripsy (IVL) technology for treating calcific artery disease. Its platform offers durable and fast energy delivery with enhanced sonic output to navigate complex arterial anatomy through a high-performing catheter. FastWave’s […]
Smiths Medical issues urgent field safety notice for some Portex tracheotomy tubes
ICU Medical’s Smiths Medical this week issued an urgent field safety notice for some of its Portex Blue Line siliconized PVC tracheotomy tubes. The company issued the warning due to an issue related to the neck plate or flange of the Portex Blue Line siliconized PVC tracheotomy tubes. The failure mode can happen during use […]