Business Wire

BioCardia Receives FDA Breakthrough Device Designation for CardiAMP Cell Therapy System for Heart Failure

SUNNYVALE, Calif.--(BUSINESS WIRE)--BioCardia®, Inc. (Nasdaq: BCDA), a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announced ...
Yahoo Finance

US FDA Medical Device Quality System (QSR) Compliance Course: Design Controls, Verification & Validation (Online Event: Oct 27th - Oct 28th, 2025)

Dublin, Sept. 22, 2025 (GLOBE NEWSWIRE) -- The "US FDA Medical Device Quality System (QSR) Compliance: Design Controls, Verification & Validation (Oct 27th - Oct 28th, 2025)" training has been added ...
BioWorld

FDA renews plan to align quality management rules with ISO standard

The FDA’s multiyear effort to rewrite the Quality System Regulation (QSR) to align with ISO 13485 could significantly ease the regulatory burden for device makers in multiple markets, but that effort ...
Business Wire

NeuroPace Receives FDA Breakthrough Device Designation for RNS System for Idiopathic Generalized Epilepsy

MOUNTAIN VIEW, Calif.--(BUSINESS WIRE)--NeuroPace, Inc. today announced that the company has received Breakthrough Device Designation status from the U.S. Food and Drug Administration (FDA) for the ...