FDA Pre-Cert Dropouts? NightWare for Nightmares. Amazon wearable.

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This is the third issue of the E&O weekly newsletter for paying subscribers. Topics include FDA Pre-cert, Amazon’s wearable plans, NightWare’s breakthrough FDA clearance and more.

Issue 003. FDA Pre-Cert Dropouts? Amazon wearable.

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FDA wants more Pre-Cert participants

In something of a surprise move, the FDA announced this week it would open its Pre-Cert program up to new participants who will be accepted on a rolling basis for what it's calling the 2019 Test Plan. The first batch of Pre-Cert participants had to show they were planning to apply for a De Novo clearance, but this new call for volunteers seeks both De Novo and 510(K) applicants. One industry insider (and longtime Pre-Cert detractor) wondered whether the news means some of the original nine participants dropped out. As a reminder, those included: Apple, J&J, Fitbit, Pear Therapeutics, Phosphorous, Roche, Samsung, Tidepool, and Verily.

Rock Health follow-up analysis to its Q1 funding report

"Since Q1 2018, the top five deals each

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FDA Pre-Cert Dropouts? NightWare for Nightmares. Amazon wearable.

FDA wants more Pre-Cert participants

Rock Health follow-up analysis to its Q1 funding report

Paying Subscribers Only

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