September 22, 2026 By Skyler Rivera FDA third-party reviewer audit policies are ‘missing key details,’ GAO report says
July 10, 2026 By Skyler Rivera What’s next for stroke telesurgery developer Sentante and the endovascular robotics field?
July 8, 2026 By Skyler Rivera FDA releases draft MDUFA VI agreement outlining proposed legislation and program changes
June 25, 2026 By Skyler Rivera FDA warns it will reject test results from three third-party labs due to ‘unreliable’ data
June 16, 2026 By Skyler Rivera FDA device shortage update includes bloodlines, biopsy needles and more
April 23, 2026 By Skyler Rivera FDA, CMS unveil accelerated Medicare coverage pathway for breakthrough devices
April 22, 2026 By Skyler Rivera FDA warns device manufacturers of nitrosamine impurities that could cause cancer
March 30, 2026 By Skyler Rivera Recall for devices that ‘exploded’ reminds us patients aren’t the only ones at risk
