Canada’s device agency plans to issue guidance on machine learning, and the FDA plans to release a draft guidance next year on lifecycle management and premarket submissions for AI devices.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

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 ...

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.

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.

Acme Revival’s business model aims to make repairs accessible and affordable, often offering repair quotes at-cost to help medical facilities, clinics, and other professionals maintain their equipment ...

As hospitals around the U.S. report IV fluid shortages, Baxter has increased supply allocations for direct customers and distributors. It plans to return to 90% to 100% allocation of certain supplies ...