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Fitbit part of FDA pilot program +4
Fitbit is one of 9 companies that the FDA has selected, from more than 100 candidates, for a pilot program to kick off a broader digital health initiative. According to Bloomberg:
the FDA will scrutinize digital health companies’ software and will inspect their facilities to ensure they meet quality standards and can adequately track their products once they’re on the market. If they pass the agency’s audits, the companies would be pre-certified and may face a less stringent approval process or not have to go through FDA approval at all.I see this as a major, albeit long-term, positive. Fitbit has some of the broadest data, and now some of the best sensors. This move by the FDA should further blur the line between data-gathering and diagnosis, thereby helping to fast-track the partnerships that I think will be important for sustained success.