By reframing security as an investment rather than a cost, MDMs can reduce risk exposure, improve compliance readiness, and ...

AI medical device companies face major reimbursement hurdles when trying to secure coverage, CPT codes, and payment from ...

Integrating Git version control with validation systems automates medical device software traceability, ensuring instant ...

Drug & Device Team provides recommendations based on Food & Drug Administration (FDA) draft guidance on Quality Management System ...

The burgeoning field of Software as a Medical Device (SaMD) offers opportunities for innovation in healthcare monitoring and delivery through mobile apps. Regulatory focus by the FDA on "device ...

In June 2025, the US Food and Drug Administration (FDA) issued a final guidance titled Cybersecurity in Medical Devices: Quality System ...

Caranx Medical ("Caranx"), a French medical device company specializing in the development of an autonomous robot to democratize access to Transcatheter Aortic Valve Implantation (TAVI), a lifesaving ...

Withings announced that its multi-function medical device BeamO has received clearance from the FDA. BeamO contains sensors to perform an electrocardiogram, a stethoscope and a thermometer. The ...

Caranx Medical ("Caranx"), a French medical device company specializing in the development of an autonomous robot to democratize access to Transcatheter Aortic Valve Implantation (TAVI), a lifesaving ...

Nandita Vijayasimha, Bengaluru Wednesday, November 19, 2025, 08:00 Hrs [IST] ...

The liability, safety, and accuracy questions underlying one creative proposal, in this week's AI Prognosis newsletter.

A DevOps-based framework integrates automation, continuous integration, and agile methodologies to enhance medical device software development. By embedding compliance verification, automated testing, ...