On Thursday, the FDA Center for Devices and Radiological Health released updated final guidance for its Breakthrough Devices Program, aimed at verifying medical devices on the market are safe and effective, and improve healthcare inequities.
The final guidance defines the FDA's interpretation of "more effective" as encompassing all the information about the device, including the risks and...
Pear Therapeutics announced Monday it had received Breakthrough Device Designation from the FDA for its prescription digital therapeutic aimed at treating alcohol use disorder, reSET-A.
The news comes just ahead of the company’s planned merger with a special purpose acquisition company, Thimble Point Acquisition Corp., which will allow it to trade publicly. Pear already has FDA-cleared digital...
Digital therapeutics (DTx) startup Swing Therapeutics has been granted FDA Breakthrough Device Designation for its smartphone-administered fibromyalgia management program.
The FDA’s Breakthrough Devices Program gives medical device manufacturers an expedited regulatory review process while offering them the chance to coordinate with the agency throughout. It intends to speed up the time it takes...
Digital mental health company Woebot Health has landed FDA Breakthrough Device Designation for its postpartum depression digital therapeutic, WB001.
WB001 combines cognitive behavioral therapy and elements of interpersonal psychotherapy with the company’s conversational chatbot, Woebot, to deliver treatment directly through patients’ phones.
Designed as a prescription digital therapeutic, the...
