September 22, 2026 By Skyler Rivera FDA third-party reviewer audit policies are ‘missing key details,’ GAO report says
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July 17, 2026 By Skyler Rivera Noninvasive sepsis SaMD developed at Johns Hopkins offers early warnings
July 8, 2026 By Skyler Rivera FDA releases draft MDUFA VI agreement outlining proposed legislation and program changes
July 2, 2026 By MDO Contributors Network Cleared for every child, covered for none, priced for the parents who can pay
July 1, 2026 By Skyler Rivera FDA device decision timelines get longer as approvals climb, report finds
June 8, 2026 By MDO Contributors Network Three ways that decentralized trial design strengthens the regulatory case for CNS devices
June 3, 2026 By MDO Contributors Network FDA rules, regulations and resources for artificial intelligence in medical devices
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
