SafeHeal Set To Bring Colovac Colonic Bypass Sheath Into Clinical Trials
SafeHeal, a collaboration between an inventor-surgeon and Paris-based medtech accelerator MD Start, has enough funding to achieve a CE mark, and is looking for a partner to help it earn a 510(k) from US FDA.
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OUS Approvals Analysis: November Product Go-Aheads Headlined by LimFlow, Abbott, Creavo
The number of medical device approvals reported outside the US rebounded in November after a very slow October. There were 14 CE marks, three approvals in Japan, and three in Canada last month, covering nine different product categories.
Medtronic Earns CE Mark For Affera Ablation System, Touts New PFA Results
Results of the PULSED AF trial confirm that Medtronic’s PulseSelect pulsed field ablation is safe and effective for atrial fibrillation ablation. The company will likely incorporate PulseSelect into its Affera cardiac mapping and ablation system, which will soon be available in Europe.
News We’re Watching – FDA Nixes Neuralink Trials, Layoffs at J&J, Novel Knee Implants
This week, we learned that the US FDA thinks Elon Musk’s Neuralink brain interface device isn’t ready for human trials. Additionally, J&J cut about 300 medtech jobs, Stryker launched a knee implant, and Active Implants’ meniscus replacement device made it to the FDA’s advisory panel calendar.