FDA Commissioner Robert Califf and two colleagues warned that the “scale of effort” needed to repeatedly evaluate AI models “could be beyond any current regulatory scheme.” ...
Canada’s device agency plans to issue guidance on machine learning, and the FDA plans to release a draft guidance next year on lifecycle management and premarket submissions for AI devices.
Johnson & Johnson’s medtech acquisitions over the past year have fueled growth for its cardiovascular group, offsetting challenges in businesses like orthopedics and surgery.