Policy & Regulation

The designation makes the watch's AFib history feature the first digital health tool to be qualified under the US FDA’s Medical Device Development Tools program, meaning it can be used in research during the development of certain cardiac devices.

Johns Hopkins professor Tinglong Dai says a subscription model for AI is the most sustainable model for reimbursement. 

A novel robotic-assisted therapy could improve the lives of men with benign prostatic hyperplasia, real-world data presented at the annual meeting of the American Urological Association suggests.

AdvaMed is hopeful that legislation at the US federal and state levels will temper third-party litigation funding, which is wreaking havoc on the judiciary system and fostering mistrust of medical devices, it says.

This week, Philips Respironics reached a $1.1b settlement affecting CPAP and other breathing devices. Toku announced it received US FDA breakthrough device designation for its MyKidneyAI technology. This May, the FDA will hold its REdI conference focusing on innovation in medical product development and hold another townhall focusing on considerations for selecting a sterilization modality.

UK pursues light-touch regulation as it forges ahead with its own approach to regulating AI but with one eye on international convergence.

Data privacy lawyer says the comprehensive, bipartisan law is “catching a lot of people’s ears.”

There are new EU regulations on medtech’s horizon following votes this month by the European Parliament. There are also unknowns when it comes to future leadership and the direction it will take as industry advocates for much-needed change.