The Feb. 25 proposed rule amends regulations on acceptance of data from medical device clinical trials done outside the U.S. to support any submission to FDA to comply with good clinical practice standards.
FDA is requiring that medical device clinical studies conducted outside the United States to support any submission to FDA be conducted with good clinical practices, including review and approval of the study by an independent ethics committee and documenting human subjects’ informed review of the study.
The Feb. 25 proposed rule is “intended to update the standards for FDA acceptance of data from clinical...
BioWales in London 2025 showcased the efforts healthtech innovators are making to meet investors on their own turf, illustrating changing attitudes and evolving needs.
Ahead of the 11 June UK spending review and its anticipated funding uplift for healthcare and life sciences, the MHRA announced an expansion of its digital expertise by creating a dedicated hub in Leeds, a renowned center of medtech excellence.
The $10m seed extension funding round will be used to launch the second-generation wearable headband with the added SmartSleep AI operating system.
