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Canada’s device agency plans to issue guidance on machine learning, and the FDA plans to release a draft guidance next year on lifecycle management and premarket submissions for AI devices.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

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

Medtronic has received Food and Drug Administration approval to study its Affera mapping and ablation system and Sphere-9 catheter to treat sustained ventricular tachycardia, an abnormal rhythm of the ...

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.

From Philips’ massive recall of respiratory devices to ongoing health risks with breast implants, medical devices tied to patient harm have put a focus on product safety. The FDA approved an early ...

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

Orion Innovations, a healthcare technology platform company, announced the expansion of its innovative product, MedLite ID, ...

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 ...

The facility also has access to water and power. Baxter expects to share production plans over the next two weeks.

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.