FDA Breakthrough designation

A close-up of a person holding a tablet
By  Emily Olsen 12:39 pm November 22, 2021
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...
Nerve cells affected by Alzheimer's disease
By  Dave Muoio 03:04 pm April 1, 2021
Those keeping an eye on the digital therapeutics industry over the last several years likely remember the name Dthera Sciences. The startup and its CEO Ed Cox became one of the developing space's many standard bearers around 2018. During that timeframe it landed a Breakthrough Device designation from the FDA for its Alzheimer's symptoms treatment, with Cox chairing a handful of industry...
By  Laura Lovett 12:10 pm October 21, 2020
Virtual reality company AppliedVR has landed an FDA Breakthrough Device designation for its technology designed to treat fibromyalgia and chronic lower back pain. The tool, named EaseVRx, combines a VR headset with visual and audio programs that deliver cognitive behavioral therapy (CBT), relaxation, and mindfulness training, as well as other behavioral methods to give what it calls “self-...