FDA Grants Breakthrough Device Designation to Dthera Sciences's DTHR-ALZ
August 23, 2018 at 09:05 am
Dthera Sciences announced that the U.S. Food and Drug Administration (the FDA) has granted Breakthrough Device designation to the Company's development-stage product, DTHR-ALZ. Under the Breakthrough Devices program, a provision of the 21st Century Cures Act, the FDA works with medical device developers to expedite regulatory review in order to give patients more timely access to a Breakthrough Device.