The FDA’s Suzanne Schwartz said at The Medtech Conference that addressing legacy devices is a “work in progress” and a problem that regulators and industry need to work on together.

Robert Ford’s comments come as new CGMs and insulin pumps continue to roll out in the diabetes tech space, including over-the-counter glucose sensors.

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Canada’s device agency plans to issue guidance on machine learning, and the FDA plans to release a draft guidance next year on lifecycle management and premarket submissions for AI devices.

Gynesonics’ transcervical system uses ultrasound guidance and radiofrequency energy to ablate fibroids without the need for an incision.

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.

From pulsed field ablation to diabetes tech and surgical robots, the updates will provide an early look at how key medtech markets performed last quarter.

Johnson & Johnson’s medtech acquisitions over the past year have fueled growth for its cardiovascular group, offsetting challenges in businesses like orthopedics and surgery.

B. Braun and Fresenius Medical Care said they will make more crucial products as the U.S. faces shortages following Hurricane Helene’s damage to a Baxter manufacturing facility.

Ryan Egeland, former CEO and co-founder of Crossfire Medical, rounds out the leadership team for the 3M spinoff.

As medtech companies, experts and regulators gather in Toronto, FDA leadership changes and the upcoming U.S. presidential election loom over the industry.

The company reported the enrollment milestone alongside news that it received clearance to sell its Advisor HD Grid X Mapping Catheter and started a trial of its Tactiflex Duo Ablation Catheter.