Neuros Medical Inc.’s Altius direct electrical nerve stimulation system significantly reduced pain in 30 minutes and continued to reduce pain for a year, a study published Sept. 24, 2024, in Neuromodulation: Technology at the Neural Interface found.

The U.S. FDA’s inspection of two facilities run by San Francisco-based Irhythm Technologies Inc., illuminated some of the usual problems with corrective and preventive action. The agency indicated that problems with skin irritation associated with the company’s Zio device should have been handled as medical device reports, a view the company apparently did not share.

The U.S. FDA announced a class I recall declared by Baxter Healthcare Corp., of Deerfield, Ill., for the automated compounding inlets used with the company’s Exactomix compounding systems due to the risk of particulate matter in the inlets.

Joe Kiani’s reign at Masimo Corp. abruptly ended following a vote at the annual shareholders meeting on Sept. 19 that saw Kiani, Masimo’s founder and CEO, ousted from the board as part of a hard-fought battle with activist investor Politan Capital Management. Michelle Brennan, a Politan nominee and former Johnson & Johnson senior executive who won her board seat last year, was named interim CEO.

The U.S. Court of Appeals for the Federal Circuit remanded a patent case to district court after finding that a patent applicant need not invoke identical terminology when describing a central feature of a catheter technology across multiple patents.

Michelle Tarver, the acting director of the U.S. FDA’s device center appeared on a Sept. 24 webinar to discuss her priorities for the agency going forward, one of which is global health equity.

Route 92 Medical Inc. sped past its series F goal, raising an additional $50 million in an extension to the oversubscribed round. The extension brings the total for the series F to $82 million, which the company plans to use to accelerate commercialization of its neurovascular reperfusion and access systems.

The U.S. FDA wrapped up the pilot version of the Accreditation Scheme for Conformity Assessment (ASCA) and reported the formation of a permanent ASCA program, which has been seven years in the making.

Researchers from UCLA’s Department of Cardiac Surgery filed for protection of a smart multistage peripherally inserted cannula with active fixation for temporary cardiopulmonary support which simultaneously drains both sides of the heart.

Azon Medical LLC, a supplier of medical products such as durable medical equipment, is on the hook for slightly more than $1 million for promoting the P-Stim device as eligible for Medicare coverage.