De Novo

By  Dave Muoio 12:09 pm February 8, 2021
The FDA has granted De Novo authorization to what will be the first device treatment for obstructive sleep apnea (OSA) that is used while the patient is awake. Called eXciteOSA, the prescription tongue muscle stimulation device is intended for those aged 18 years or older to reduce mild sleep apnea and snoring. Patients use the device for 20 minutes once per day over a six-week period, and...
Motor vehicles stalled in a traffic jam
By  Bradley Merrill Thompson 09:35 am December 23, 2020
It’s been quite a year: COVID-19, a change in administration and a year of transition for FDA digital health policy. In light of all the change and uncertainty, many digital health companies are struggling to decide upon a regulatory strategy for 2021. My advice? If at all possible, stay away from FDA. They have enough to do right now. The people I know at FDA have been working 12- and 15-hour...
A green traffic light
By  Dave Muoio 03:50 pm December 8, 2020
Editor's note: This story has been updated with quotes and additional information from Mahana's CEO and cofounder. The FDA has granted a De Novo clearance to San Francisco-based Mahana Therapeutics' Parallel, a prescription digital therapeutic for patients with irritable bowel syndrome (IBS) that delivers cognitive behavioral therapy (CBT). The agency made its decision on November 25, according...
Images of the NightWare app on Apple Watches
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...
By  Dave Muoio 09:45 am September 23, 2020
Cognoa, a digital health company developing software tools for children with autism and other behavioral health conditions and their families, signaled today that it will be moving ahead with a De Novo FDA regulatory submission for its digital autism spectrum disorder (ASD) diagnostic. The tool, which received a Breakthrough Device Designation from the agency in late 2018, is designed to help...
By  Dave Muoio 05:39 pm June 15, 2020
After years of waiting, Akili Interactive has finally received FDA De Novo marketing authorization for EndeavorRx, its video-game digital therapeutic for children aged 8 to 12 years with ADHD. This is the first game-based therapeutic that the FDA has greenlit for any condition, the regulatory agency noted in its announcement. It is also the first authorization for Akili, which has a handful of...
By  Dave Muoio 04:38 pm February 7, 2020
The first artificial intelligence-enabled cardiac ultrasound software has received De Novo marketing authorization, the FDA announced today. Developed by Caption Health, the Caption Guidance tool guides medical professionals through a heart disease diagnostic test that normally requires an ultrasound expert. “Echocardiograms are one of the most widely-used diagnostic tools in the diagnosis and...
By  Dave Muoio 02:13 pm December 16, 2019
The FDA announced Friday a De Novo clearance for an interoperable automated glycemic controller device for use in a hybrid closed-loop diabetes management system. Tandem Diabetes Care’s Control-IQ Technology acts as a new feature for the company’s t:slim X2 insulin pump (which was also cleared by the FDA back in February). The controller algorithm allows the pump and its connected system to...