FDA

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

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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.

Dascena's COViage system uses demographic and vital-sign data pulled from a COVID-19 patients' EHR to calculate their risk of hemodynamic instability or respiratory failure.

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

Although still a work in progress, the new center will reportedly help coordinate digital health projects within the agency while providing expertise to external stakeholders.