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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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.
The company is running a pilot program to allow glioblastoma patients who use Novocure’s Optune Tumor Treating Fields device to download data from the device at home.
The company is sponsoring research on how the blood oxygen sensor feature on its Apple Watch 6 could be applied to specific health problems.