De Novo

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...