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 ...

After expanding in global markets, the U.K.-based company will challenge Intuitive Surgical in the U.S., starting with gallbladder removal procedures.

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Canada’s device agency plans to issue guidance on machine learning, and the FDA plans to release a draft guidance next year on lifecycle management and premarket submissions for AI devices.

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.

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

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.

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

Startups notched 110 deals in the third quarter, compared with 133 in the second quarter. But average deal size held steady, suggesting investors are making “fewer, more focused bets,” according to ...