Emergency Guidance Clears Way For COVID-19 Blood Clot Detection Devices

The US FDA says PFAS used in medical devices are safe and that there’s no reason to restrict them in device production. An environmental group finds the agency’s assertion questionable.

EU4Health, the main funding instrument for EU health initiatives, has put renewed emphasis on orphan devices in its 2025 work program, published in July.

The US FDA has authorized around 107 devices with Predetermined Change Control Plans in place, with PathAI's AISight Dx digital pathology image management system one of the latest. Medtech Insight talks to Eric Walk, chief medical officer, to find out about the process and its benefits.

The Centers for Medicare and Medicaid Services has launched a new program the agency says will allow patients easier access to their health data. More than 60 companies have already signed on.