Swing Therapeutics’ Fibromyalgia Software Designated Breakthrough Device

San Francisco startup Swing Therapeutics has received the FDA’s Breakthrough Device designation for its 12-week smartphone-based fibromyalgia management software.

The software, which provides a form of cognitive behavioral therapy, expands upon an online program developed at the University of Manitoba that was shown to improve function and symptoms for people living with fibromyalgia.

The company has completed a pilot study of the software and is now planning a pivotal trial to support an application for 510(k) marketing clearance.