Former CDRH leader Jeff Shuren told an audience at The Medtech Conference that Michelle Tarver “will make an excellent center director, and quite frankly, the best is yet to come.” ...
identifeye HEALTH, a medical diagnostics company at the forefront of AI and automation, is proud to announce the launch of the identifeye System, a retinal imaging camera designed to bring retinal ...
The FDA’s Suzanne Schwartz said at The Medtech Conference that addressing legacy devices is a “work in progress” and a problem regulators and industry need to work on together.
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Canada’s device agency plans to issue guidance on machine learning, and the FDA plans to release a draft guidance next year on lifecycle management and premarket submissions for AI devices.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.
The FDA approved an early feasibility study of Medtronic’s Affera mapping and ablation system and Sphere-9 catheter in patients with ventricular tachycardia, an abnormal heart rhythm.