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These 9 companies made it to the FDA’s pilot digital health program (Updated)

The picks span telecom giants to medtech companies but also include smaller companies with novel technologies such as digital therapeutics developer Pear Therapeutics and Tidepool — an open source technology developer to support diabetes management, .

By Stephanie Baum on September 26, 2017

This article has been updated with more information about companies selected for the program

The U.S. Food and Drug Administration has selected nine technology companies for the pre-certification pilot program to streamline the digital health regulation process. FDA Commissioner Dr. Scott Gottlieb announced the nine businesses in his keynote address at the AdvaMed MedTech Conference in San Jose on Tuesday. They were whittled down from more than 100 applicants.

The picks reflect some unsurprising choices such as telecom giants Apple and Samsung and medtech companies Johnson & Johnson and Roche. But it also included relatively young businesses such as Pear Therapeutics, which recently secured 510(k) clearance for the first digital therapeutic to treat substance abuse.

By taking a closer look at the companies developing the technology and evaluating the processes they use to review systems for software design, validation and maintenance, the regulator hopes to determine whether the company meets quality standards and pre-certify those businesses.

In an interview at the AdvaMed MedTech conference, Bakul Patel, associate director of digital health at FDA’s Center for Devices and Radiological Health, was asked why the nine companies were selected.

“The nine represent a flavor of tech, traditional device, and small companies,” he said. “The fundamental thing was where can we learn the most from.”

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The full list includes:

  • Apple in some ways has had a significant influence on digital health developers based on the rules it has set down for its app store. It has also set out to deepen the relevance of its smartphone and smartwatch for healthcare, not only through CareKit and ResearchKit to support studies but also with its heart monitoring sensors through studies with Stanford University.
  • Fitbit has also sought to position itself as more than just a fitness device but also as a wearables and health tech business striving to move the needle on reducing obesity and improving chronic conditions in wellness programs.
  • Johnson & Johnson digital health activities span its health and wellness solutions business as well as collaborations through its subsidiary businesses Ethicon in surgery tech and Lifescan for diabetes management.
  • Pear Therapeutics was the first company to get cleared for a digital therapeutic so it’s fair to say this business has earned its stripes balancing innovation with the rigors of regulatory approval.
  • Phosphorus The diagnostics company performs genetic tests through its CLIA-certified lab, but it also develops analytics tools to support these tests.
  • Roche has been increasing its collaboration with digital health companies which culminated in its acquisition of interactive diabetes management app developer mySugr in June.
  • Samsung Among the company’s more interesting projects is its use of virtual reality in clinical settings. It is collaborating with other companies, such as Applied VR, to reduce pain and anxiety for children and adults and to reduce reliance on opioids. The company is also interested in bringing artificial intelligence to stroke care.
  • Tidepool is a nonprofit developing open-source tools developer in support of people with Type 1 diabetes.
  • Verily Given how secretive the life science arm of Alphabet is, Verily’s participation in the FDA’s pre-certification pilot program is particularly interesting. As part of the program, participants have agreed to provide access to measures they currently use to develop, test and maintain their software products, including ways they collect post-market data, according to the news release. Although Verily hasn’t altogether shifted away from its ambitious moonshots, its 10,000 volunteer Project Baseline in collaboration with Stanford Medicine and Duke University School of Medicine will be a four-year medical study to search for new predictors of disease through a combination of clinical tests and passive monitoring with wearables. The company’s recruitment of former FDA commissioner Robert Califf also makes more sense in this context.

Arundhati Parmar contributed to this story

Photo: Jirsak, Getty Images