FDA

The system delivers its results to a companion app in about 20 minutes, according to the agency.

Industry regulatory leaders outline the best approaches for digital health companies looking to make sense of FDA's long-in-the-tooth enforcement discretion guidelines.

An article in NEJM reports that pulse oximeters missed occult hypoxemia in more Black patients than white.

Also: docdok.health rolling out COVID-19 vaccination study app; IBM Watson Health partners with Humana.

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

Also: FDA pushes back on Nanox's "digital X-ray" 510(k) and clears B-Secur's ECG algorithms.

Also: Cleo names three new leadership positions. 

Quantib and Ezra's automated tools support diagnosis and measurement of the prostate and prostate lesions, while Aidoc's algorithm acts as an always-on catch net for unsuspected blockage of pulmonary arteries.

More expertise will be necessary if the regulator is to keep up with the constant evolution of real-world evidence, privacy and other data-driven challenges, Dr. Hahn said.

Bradley Merrill Thompson, an FDA-watcher, lawyer and occasional MobiHealthNews guest contributor, joins the MobiHealthNews team for a closer look at what the FDA has been up to around digital health and AI.