FDA Selects Nine Companies to Test Fast-Track Approval for Health Technology (Sep 26, 2017)

The US Food and Drug Administration has pushed forward with plans to test a fast-track process for approving technological approaches to healthcare problems, and has selected nine companies to be part of its pilot program, including Apple, Fitbit, Samsung, and Alphabet’s Verily life sciences unit. Apple has long said that the need to get FDA approval for health-related products would likely dissuade it from entering that market directly, though it’s managed to serve that market indirectly through partners taking advantage of its ResearchKit and other programs. Both Apple and Fitbit have been pursuing health-related applications for their devices, and Samsung launched a virtual doctor service as part of its Galaxy S8 launch earlier this year, so this is clearly a hot area for these consumer tech companies. The FDA deals mostly with products with diagnostic or treatment applications, which is why so much health and wellness tech tends to stop short of those categories and merely provide data and alerts. But the potential for doing more is already clear, and with faster FDA approval we could well see these companies go deeper into this field. It’s still early in this process, and there might still be other downsides including the potential for leaks while approval is being sought, which is likely to give Apple in particular pause, but this is a positive step for both the industry and for end users.

via Bloomberg

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• Alphabet
• Apple
• Apple Watch
• Fitbit
• Samsung
• Verily

• Healthcare
• Regulation
• Wearables

• Wearables are Struggling

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