Regulation

The Analytic for Hemodynamic Instability tool can identify hemodynamic instability with 96% sensitivity and detects stable patients with 85% specificity.   

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.

The process aims to ensure tools meet NHS standards.

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

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

The move has been lauded by the GMDN Agency as a “valuable resource for the UK healthcare sector”.

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.

AppliedVR's EaseVRx landed an FDA Breakthrough Device designation for its tool that combines VR and cognitive behavioral therapy. 

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.