Brixton Biosciences Inc. closed a $33 million series B funding round that it plans to immediately use to pursue two clinical trials to evaluate the use of its Neural Ice nerve block for knee pain. The injectable product received U.S. FDA breakthrough device designation in October.

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.