In a rare move, the FDA is taking steps to ban electrical stimulation devices (ESDs) for self-injurious or aggressive behaviors. Owen Faris, acting director of the Office of Product Evaluation and Quality (OPEQ) in the FDA’s Center for Devices and Radiological Health, announced the proposal this week, marking the second attempt by the agency to […]
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FDA approves next-gen Evolut TAVR system from Medtronic
Medtronic announced today that the FDA approved its next-generation Evolut FX+ transcatheter aortic valve replacement (TAVR) system. The FDA’s approval covers the treatment of symptomatic aortic stenosis. Medtronic says the latest version of the Evolut valve maintains the performance of the Evolut platform with a design that facilitates coronary access. Evolut FX+ TAVR offers larger […]
Edwards Lifesciences’ chair Michael Mussallem retires from board
Edwards Lifesciences announced that Chair Michael Mussallem is retiring from the board of directors a year after stepping down as CEO. Mussallem became a non-executive chair of the Irvine, California-based company after he retired from his CEO post on May 11, 2023. He is expected to be succeeded by independent director Nicholas Valeriani, who will […]
Shockwave Medical is reportedly a J&J acquisition target
Shockwave Medical could get acquired by Johnson & Johnson , according to a Wall Street Journal report. WSJ cited people familiar with the matter. They said the acquisition talks, if successful, could result in a finalized deal in the coming weeks. Another suitor could also seek a merger with Santa Clara, California–based Shockwave. The WSJ […]
NeuroOne begins neuroablation system launch in U.S.
NeuroOne Medical Technologies (Nasdaq:NMTC) announced today that it initiated a limited commercial launch for its OneRF ablation system. The Eden Prairie, Minnesota–based company said its initial rollout comes earlier than it previously expected. It picked up FDA 510(k) clearance for the OneRF system just over three months ago in December 2023. Indications cover the creation […]
Fast Company names 10 medtech companies as most innovative of 2024
Fast Company recently named 10 medical device companies as some of the most innovative companies of 2024. Each year, Fast Company releases its list of the world’s most innovative companies. The list covers 58 industries and sectors, ranging from advertising to video. Companies on the “Most Innovative” list apply to be included, and then Fast […]
Abbott wins CE mark for insertable cardiac monitor
Abbott announced today that it received CE mark approval for its Assert-IQ insertable cardiac monitor (ICM). The ICM provides a new option for diagnostic evaluation and long-term monitoring in people experiencing abnormal heartbeats. It can detect hard-to-spot irregularities in heartbeats and help physicians determine the best treatment course. Assert-IQ received FDA clearance in May 2023, […]
FDA clears Neuronetics’ neurostim for adolescents with depression
Neuronetics (Nasdaq:STIM) announced today that it received FDA clearance for the use of its NeuroStar therapy for adolescent patients. Clearance covers the use of NeuroStar as an adjunct treatment of major depressive disorder (MDD) in adolescent patients aged 15-21. Neuronetics said clearance makes NeuroStar the first and only transcranial magnetic stimulation (TMS) treatment cleared for […]
J&J’s Biosense Webster submits Varipulse pulsed field ablation system for FDA approval
Johnson & Johnson MedTech’s Biosense Webster announced today that it submitted its Varipulse platform to the FDA for premarket approval. The company supported its PMA submission for the pulsed field ablation (PFA) system with results from the admIRE study. It aims to garner approval for the treatment of paroxysmal AFib. If approved, Varipulse would become […]
Masimo looks to separate consumer business two years after $1 billion buyout
Masimo will move forward with a proposal by Chairman and CEO Joe Kiani to separate the medtech developer from its consumer business. Kiani would remain chair and CEO of Irvine, California–based Masimo and serve as chair of the new consumer company, which includes Sound United parent company Viper Holdings that Masimo bought for $1.025 billion […]
Former Neuropace CEO takes the helm at Revamp Medical
Revamp Medical this week announced it appointed Mike Favet as CEO, effective immediately. Favet joins the Netanya, Israel–based heart failure congestion management company with more than 20 years of executive-level experience. He most recently was CEO of Neuropace, where he led a commercial expansion and took the company public in 2021. “Mike brings a distinguished […]