Medtech regulation outlook in 2023: Faster approvals among priorities as AI moves to fore

For medical device makers – and the patients who rely on them – 2023 is poised to be a year of challenge and change for regulation.

A post-COVID-19 surge in applications for review and the burgeoning role of artificial intelligence and machine learning — combined with swift advances in monitoring technology and wearable sensors — have pushed digital health to the fore.

That’s forcing the Food and Drug Administration to conceive of new ways to address the safety of devices that are continuously updating or even learning on the job.