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FDA speeds approval for Apple, other tech companies

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Apple, Alphabet and Samsung’s future forays into medical software could get speedier FDA approval thanks to a new program announced Tuesday.

The FDA is launching a pilot program that will give vetted tech companies pre-approval to work on medical software. The government agency oversees drug and medical device approval, in addition to food and health products. It has already pre-certified nine companies, including Apple, Samsung, Alphabet’s Verily, FitBit, Roche and Johnson & Johnson.

The program is a slight departure from how the process usually works. It is focused on approving companies themselves instead of each individual product. Getting FDA approval for individual products can be a lengthy and expensive process. This could allow companies more leeway to innovate quickly.

Related: Apple’s newest gadgets include iPhone X and Apple Watch Series 3

“Our method for regulating digital health products must recognize the unique and iterative characteristics of these products,” said Scott Gottlieb, the FDA commissioner, in a statement. “We need to modernize our regulatory framework so that it matches the kind of innovation we’re being asked to evaluate.”

The FDA will use to the program to determine if its possible for companies to submit less information to the agency when seeking pre-market approval for a product, or if some products can skip the step all together.

Apple has shown interest in the medical space for years, most recently with Heart Study, a new trial that uses the Apple Watch to detect atrial fibrillation. The company said it was working with the FDA on the program. Verily, Alphabet’s life sciences division, is working on biomedical medicine, smart contact lenses and glucose monitoring products.

More smartphones and wearables are cramming in sensors that can handle medical monitoring, like heart rate, body temperature and activity levels. It makes sense that the companies would consider making the leap from wellness to medical applications.

Apple had no comment on the announcement.



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