De Novo

The company was also the first to receive emergency use authorization for its home COVID-19 test in 2021.

The tool uses virtual reality to modify media content in order to help children boost their visual acuity. 

The eXciteOSA strengthens tongue muscles through electrical stimulation, and comes with a companion app for tracking and sharing progress.

As the agency's workload swells with the weight of a public health emergency, digital health companies on a timeline should consider whether their products truly warrant a regulatory submission, writes Epstein Becker & Green's Bradley Merrill Thompson.

Mahana Therapeutics' Parallel is a three-month digital treatment that logs patients' symptoms to deliver relevant guidance and teach them condition-management skills.

NightWare's digital therapeutic monitors a wearer's heart rate and movement to detect disturbances during sleep, and delivers gentle vibrations to interrupt a nightmare without waking the user.

The company said that its tool was "highly accurate" in a 425-participant study conducted across 14 U.S. sites.

The long-awaited decision is the first regulatory authorization for Akili, and the first game-based therapeutic that the FDA has greenlit for any condition.

Caption Health's tool instructs non-expert medical staff on how best to produce high-quality diagnostic images in real time.

The clearance of Tandem Diabetes Care’s Control-IQ Technology opens the door for new algorithms enabling hybrid closed-loop diabetes management systems.