September 22, 2026 By Skyler Rivera FDA third-party reviewer audit policies are ‘missing key details,’ GAO report says
September 10, 2026 By Julia Rock-Torcivia Oura discloses pay packages for top executives ahead of IPO
August 31, 2026 By MDO Contributors Network How to make smarter polymer choices for disposable drug delivery devices
August 18, 2026 By Jim Hammerand Qosina launches regulatory services for device developers and manufacturers
July 21, 2026 By MDO Contributors Network AI is moving inside the device. Who owns the clinical risk?
July 17, 2026 By Skyler Rivera Noninvasive sepsis SaMD developed at Johns Hopkins offers early warnings
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
July 1, 2026 By Skyler Rivera FDA device decision timelines get longer as approvals climb, report finds
June 26, 2026 By Jim Hammerand What’s UpDoc? The SaMD developer says it’s the first FDA-cleared clinical AI platform
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
June 11, 2026 By Jim Hammerand A boy’s death is a tragic example of foreseeable risk in device design
