In this week’s roundup: The US Senate unveils its draft FDA user fee bill, including comprehensive VALID Act reforms to regulation of diagnostics, while the House moves its user fee bill out of committee. EU regulatory updates including MedTech Europe preps for the IVD Regulations, more progress on standards recognition, and more MDR bottleneck data from notified bodies. Also, Google taps Bakul Patel, GAO looks at FDA COVID test efforts, and more global medtech policy updates.
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Movano's strategy from the outset was to position itself as a medical device company and to seek FDA clearance for its wearable products. Read our interview with CEO John Mastrototaro inside. Neuroelectrics CEO Ana Maiques talks about developing her company's precision brain stimulation therapy and the need for greater diversity in the medtech C-suite. Plus a look at Sonder Capital, a VC firm with deep roots in the device industry, and profiles of CurvaFix, EvoEndo, and Onera Health.
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March's most-read articles: Edwards Lifesciences exec roundtable, 20 diabetes companies to watch, Magnus Medical's depression treatment, the diagnostics industry post-COVID, and Alva Health's wearable stroke monitor.