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.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Medici Medical, Morgan Scientific, Nanovibronix, Nova Biomedical, Paindrainer, Terumo Blood, Translumina, Vitalograph.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Genetesis, Piur Imaging, Rhythm AI.
The draft Medicare physician fee schedule for calendar year 2025 provoked a strong backlash from physician societies due to a net cut in physician pay. Device makers have their own concerns, including the latest in a series of controversies over coverage of skin substitutes.