There should be no more excuses to the adoption of renal denervation (RDN) as a treatment for hypertension given the recent approval by the U.S. FDA of two technologies and a range of guidelines recommending the therapy, delegates heard at the EuroPCR conference in Paris. In a discussion on the technology, panelists argued that on the back of solid evidence, RDN should be offered as a treatment given that the therapy is a safe method to reduce high blood pressure.

The FDA’s Jeff Shuren appeared on a May 14 webinar to discuss operations at the Center for Devices and Radiological Health (CDRH), but he had some choice words for what he suggested is a widespread do-more-with-less mentality. Shuren said that expectations of CDRH’s capacity are in defiance of what he suggested is a modest volume of revenues the center receives each year, a predicament he said demonstrates that “a lot of people are running around stupid” about the realities at the FDA’s device center.

A pair of co-published filings from Naples, Fla.-based Aerwave Medical Inc. describe apparatus and ultrasound-based methods for bronchial denervation, ablating smooth muscle or goblet cells, and emphysematous tissue remodeling in the treatment of respiratory conditions such as asthma and chronic obstructive pulmonary disease.

The U.S. FDA issued a May 9 warning letter to Cue Health Inc., of San Diego, following what may have been a routine inspection, but the inspection disclosed that the company had made changes to a COVID test that was granted market access via the emergency use authorization program.

Profound Medical Corp. received U.S. FDA 510(k) clearance for its second transurethral ultrasound ablation (TULSA) module using artificial intelligence. When used with Profound’s TULSA-Pro system, the Contouring assistant helps physicians more quickly and accurately segment prostate imaging and design treatments.