The U.S. FDA granted 510(k) clearance for Clew Medical Ltd.’s artificial intelligence (AI)-based solution that can predict hemodynamic instability in ICU patients eight hours in advance of deterioration. The system continuously monitors and stratifies patients by risk level to enable optimization of ICU resources.

U.S. FDA warning letters have been a staple of regulatory life since the late 1990s, but James Boiani, a regulatory attorney with Epstein, Becker & Green P.C., said it’s no stretch of the imagination that warning letter volumes will jump in 2021. This is to some extent because the volume of warning letters dropped significantly over the past four years, and Boiani advised that all FDA-regulated industries will see more warning letters unless they are communicative with the agency about inspectional findings.

The U.S. FDA is still struggling to keep up with the volume of diagnostic emergency use authorizations (EUAs), but it is not for want of effort. Tim Stenzel, director of the FDA’s Office of In Vitro Diagnostics and Radiological Health (OIR), said on the Feb. 3 testing town hall that the agency is processing nine such applications per day, a big jump over the rate of one per day in the early weeks of the COVID-19 pandemic.