Regulation

Professional health organizations make statements on the new administration. 

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.

This week's top stories include HHS requiring hospitals to report flu data, Americans wanting mental healthcare via telehealth, and Clover Health joining the public market by merging with Social Capital SPAC.

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.

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.

Panelists at DTx East discuss the difference between 510(k) clearances and enforcement discretions, and why research should go beyond the FDA threshold. 

Dr. Amy Abernethy, principal deputy commissioner at the U.S. FDA, discusses the FDA's role in balancing innovation, regulation and safety during the coronavirus pandemic.