As Fitbit shifts to clinical technology, FDA likely to add scrutiny

After finding success with a series of fitness trackers, Fitbit is looking to make the next step and transform itself into a digital health company that relies less on fitness consumers and more on the healthcare industry. The transitional push could draw the attention of the Food and Drug Administration, according to Bloomberg.

Competition for Fitbit has stiffened recently, and the company's new products are not selling as swiftly as planned. The company faces pressure from investors for growth as shares have fallen by more than 40 percent this year.

Fitbit CEO James Park told Bloomberg the next natural step for Fitbit is to enter into clinical technology. The nine-year-old company has more than quintupled its research and development budget to $150 million. Fitbit researchers and engineers are working to create more advanced sensors and move product development in the direction of medical-grade technology. Fitbit could eventually produce products that monitor blood sugar, blood pressure and potentially offer diagnostic capabilities.

Some have called the accuracy of the company's sensors into question. A class action lawsuit filed by consumers has alleged that the devices heart-monitoring sensors are wildly inaccurate.

"People need to use common sense. It's not a medical-grade device; it's a consumer device. In that setting, it works incredibly well. You should probably follow your doctor's advice and use whatever device they prescribe to you. Just use your judgment," Mr. Park told Bloomberg when asked about the suit. The company plans to strongly contest the claims.

Some experts think the Fitbit move makes sense in the long run, but could present the company with some immediate challenges.

Steven Wardell, a digital health analyst at Leerink Partners, told Bloomberg, "The healthcare market is still early-stage and is going to be more expensive to develop for than the consumer market...if they choose to make clinical claims and seek FDA approval, then they'll probably find that it will cost more and take longer."

Mr. Park expressed little concern over the potential hurdles created by federal regulation, saying, "I think we've had a pretty open policy with regulators...I've been out to D.C. multiple times already. We want to work together with the government to find the right balance."

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