Policy & Regulation

Teal Health reached a significant milestone in its mission to bring a prescription-based, at-home, self-collect cervical cancer screening device to market.

The Netherlands’ Central Committee on Research Involving Human Subjects is gauging sponsor demand for a new scientific advice service for clinical trials, which is for now free of charge.

UK devices regulator signals near-term progress on PMS statutory instrument, policy statement on international recognition and input into IMDRF project to update  global diagnostics guidance.

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.

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.