While AI adoption in GMP settings is still evolving, regulatory agencies emphasize explainability and validation of AI models.

Three of AAMI’s most notable sterilization guidance documents were ... were all recently updated by AAMI, and FDA recognition is an important validation of the new editions’ usefulness for ...

The justices handed a win, for now, to the Food and Drug Administration in its rejection of applications from makers of ...

The Company's 510(k) submission included performance data and validation ... FDA issues an AI request, the 90-day review clock is paused. The Company has reviewed the AI request and is in the ...

and is seeking feedback on the guidance through consultation. In addition to releasing the draft merger process guidelines, the ACCC has also published a simpler quick guide for business and others ...

NightOwl is now widely available across the United States. Individuals interested in NightOwl should speak with their healthcare provider for more information. To learn more, visit: https://www.resmed ...

Biosensors are changing how we monitor health, but rapid innovation raises tough questions around privacy, regulation, and ...