Digital therapy program for fibromyalgia receives FDA breakthrough device designation – TechCrunch

"Swing Therapeutics, a digital therapeutics startup, has received an FDA breakthrough device designation for their 12-week smartphone-assisted fibromyalgia management program. This is the company’s first breakthrough designation, and precedes a deluge of clinical trials scheduled for this year.

Swing Therapeutics was founded in 2019 and has raised a total of $9 million in seed funding led by JAZZ Venture Partners. The company is focused on managing chronic pain, and specifically fibromyalgia.

This FDA breakthrough designation was awarded to the company’s smartphone adaptation of an acceptance and commitment therapy (ACT) program originally designed and tested at the University of Manitoba. Swing Therapeutics has exclusively licensed the program, and adapted it to form their own phone-based version.

“We basically used [The University of Manitoba program] as a basis for our program and then really built on top of it, and adapted it to a sort of experience that would work great for a modern-day smartphone interface,” says Mike Rosenbluth, the founder and CEO of Swing Therapeutics.

This FDA designation will allow Swing Therapeutics expedited review at the FDA as the company conducts a series of clinical trials on the product..." Lire la suite