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Also: Pear Therapeutics receives FDA SteP designation for its product candidate focused on acute and chronic pain, and Carbon Health launches its diabetes management program.
SAN FRANCISCO, Calif. (PRWEB) February 03, 2022 -- (February 3, 2022) Lover, the digital therapeutic app for improving users’ sex lives and treating sexual
Falls Church, VA (PRWEB) December 01, 2021 -- Special Pathways for Innovative Devices: A Guide to the FDA’s Breakthrough Device and Safer Technologies
/PRNewswire/ -- MCRA, LLC, a leading medical device, in-vitro diagnostic, and biologics advisory firm and clinical research organization (CRO) integrating U.S....
Med Device Online - March 10, 2021 The pandemic year of 2020 presented FDA with many enormous challenges, including how to use emergency authorizations to approve diagnostic tests, personal protective equipment, and therapies, how to conduct remote inspections, and what accommodations should be made for clinical trials disrupted by COVID-19. On top of that, FDA found itself facing an enormous and unprecedented amount of political pressure, with its actions, or lack thereof, potentially altering the presidential election. Yet through it all, the agency continued to largely fulfill its core res...