NightWare

FDA grants De Novo clearance to prescription Apple Watch app for nightmare disorder

By Dave Muoio 02:47 pm November 9, 2020

The FDA granted Minneapolis-based NightWare a De Novo clearance on Friday for its Apple Watch and iPhone app designed to improve the sleep quality of those experiencing nightmare disorder and nightmares related to PTSD. The digital therapeutic – which received breakthrough designation from the agency last year – uses the Watch's sensors to track the heart rate and movement of users as they sleep...

Apple Watch app for nightmare disorder receives FDA breakthrough designation, opens enrollment for two RCTs

By Dave Muoio 03:48 pm May 21, 2019

Minneapolis-based NightWare — maker of a smartwatch therapeutic for people with nightmare disorder and PTSD-driven nightmares — has received breakthrough therapy designation for its in-development product. In addition, the company is launching two new placebo-controlled randomized clinical trials for its digital intervention, one of which is being conducted within Department of Veterans Affairs...