The FDA action follows the finalisation of a 'reflection paper' by the EMA last year, setting out the EU regulator's thinking on the use of AI in the medicinal product lifecycle. Medical device ...

The Food and Drug Administration (FDA) published new guidance for AI-enabled medical devices on January 7, 2025. These are nonbinding and not for implementation. The public comment window for ...

Perimeter Medical Imaging AI, Inc. (TSXV: PINK) (OTCQX: PYNKF) ("Perimeter" or the "Company"), a commercial-stage medical technology company, today announced the submission of a Premarket Approval ...

Avant Technologies, Inc. (OTCQB: AVAI) ("Avant" or the "Company"), and its partner, Ainnova Tech, Inc., (Ainnova), a leading healthcare technology company focused on revolutionizing early disease ...