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Apple selected to FDA pilot program to fast-track medical tech

September 26th, 2017 at 4:31 PM
Apple Watch heart rate tracking

Bloomberg reported today that Apple has joined a Food and Drug Administration program to fast-track the development of medical technology. The FDA selected nine companies in total for its program, which will allow companies to avoid some of the regulations that surround health products.

“We need to modernize our regulatory framework so that it matches the kind of innovation we’re being asked to evaluate,” FDA Commissioner Scott Gottlieb told reporters.

Apple, Fitbit, and Samsung are the three big tech companies on the list, with Verily Life Sciences — a division of Google parent Alphabet, Johnson & Johnson and Roche Holding AG also included. Apple has hinted before at products to monitor blood glucose levels non-invasively, and its new Apple Watch has a pilot program for continuous heart rate monitoring in order to detect heart abnormalities.

“Historically, health care has been slow to implement disruptive technology tools that have transformed other areas of commerce and daily life,” Commissioner Gottlieb said in July, when unveiling the program.

Under the terms of the program, the FDA will scrutinize prospective products to ensure they’re going to meet quality standards, and using robust metrics and data. The agency also wants a system in place to audit results from devices. Provided those terms are met, the FDA will limit other regulatory hurdles that medical devices normally have to go through.




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