Regulation
Dr. Yuri Maricich, chief medical officer at Pear Therapeutics, speaks on his company's experience bringing a digital therapeutic product through the regulator's experimental program for health software.
Somryst, a prescription digital therapeutic combining cognitive behavioral therapy and personalized sleep restriction, is the first software product to put the FDA's early Precertification Program framework through its paces.
The Auto Ejection Fraction Tool and the Auto Bladder Volume Tool both employed AI to help Butterfly iQ users more easily evaluate the patient's condition.
Nurx, Carbon Health and Everlywell have officially halted their mail-order testing-kit services. But at least one startup is still moving to secure an Emergency Use Authorization for its at-home rapid serology diagnostic.
The temporary policy also extends to some clinical decision support software used in conjuction with these remote monitor devices.
The company plans to roll out a corresponding app this Spring.
Experts will work with social media giants to curb the spread of misleading and deceiving claims.
Elizabeth Warren (D-MA), Richard Blumenthal (D-CT) and Dr. Bill Cassidy (R-LA) sent a follow-up letter to Ascension CEO Joesph Impicciche regarding privacy concerns about Project Nightingale.
The software can be used on a clinician's smartphone or tablet.
Trade association raises concern that new regulatory system is not ready to support the transition of technology.