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FDA de novo

By Emily Olsen | 12:43 pm | November 17, 2021
The news comes about a week after AppliedVR announced it raised $36 million in Series B funding.
By Dave Muoio | 10:45 am | September 23, 2020
The company said that its tool was "highly accurate" in a 425-participant study conducted across 14 U.S. sites.
By Dave Muoio | 05:38 pm | February 07, 2020
Caption Health's tool instructs non-expert medical staff on how best to produce high-quality diagnostic images in real time.
By Dean Koh | 06:29 am | July 24, 2019
Australian digital health company PainChek recently announced that the United States Patent Office has issued a Notice of Allowance for its pain assessment invention.
By Dean Koh | 11:40 pm | May 28, 2019
Theranica, an Israel-based biomedical technology company focused on developing advanced electroceuticals for migraine and other prevalent diseases, announced on May 28 that the U.
By Dave Muoio | 04:18 pm | February 19, 2019
The Tandem Diabetes Care t:Slim X2 can work in tandem with other blood sugar management devices, or on its own.
By Laura Lovett | 11:25 am | January 08, 2019
FDA Comissioner Dr. Scott Gottlieb announced a new Digital Health Innovation Action Plan, Pre-Cert Test Plan for 2019 and a Working Model. 
By Jonah Comstock | 05:10 pm | September 13, 2018
The announcement has drawn questions about novelty and claims of coziness with the FDA.
By Jonah Comstock | 09:56 am | January 26, 2015
The old Dexcom Share, with charging cradle.