What will the industry face or achieve in 2025? These trends will be critical in medical device cybersecurity.

An important facet of AI regulation is where in the supply chain AI should be regulated—specifically, whether to regulate the ...

The Centers for Medicare and Medicaid Services ("CMS") published a final notice outlining the processes and procedures for the Transitional ...

MDR Certification Strengthens Resyca’s Leadership in Soft Mist Drug-Device Combination Products ENSCHEDE, NL / ACCESS ...

EQS-News: aap Implantate AG / Key word (s): Regulatory Approval/Miscellaneous Progress in the MDR process - aap receives MDR certificate 27.01.2025 / 14:00 CET/CEST The issuer is solely responsible ...

New documents clarify how the FDA plans to regulate AI-enabled devices, experts say, but several important questions remain ...

With each new year comes a new set of accompanying challenges, from tackling the latest innovations to new incarnations of old issues. 2025 will be ...

CMS has accepted EBR's WiSE cardiac resynchronisation therapy (CRT) system into the fast-track TCET reimbursement pathway. ..

DUBLIN--(BUSINESS WIRE)--The "The Role of the Person Responsible for Regulatory Compliance (PRRC) Under the MDR (Medical Device Regulation) and IVDR (In-Vitro Diagnostic Regulation) Training ...

Research spanning more than 20 years has led the UPV/EHU's Neurochemistry and Neurodegeneration group under Dr. Rafael Rodríguez-Puertas to discover a promising avenue for the development of new ...