The 510(k) decision clears the device for use with ultra-rapid-acting insulins from Eli Lilly and Novo Nordisk.

The full financial impact of the price hikes could exceed $67 million each year in two dozen markets, according to the new ...

Johnson & Johnson’s Abiomed has sent an urgent medical device correction about a malfunction risk linked to 22 reports of ...

Pulsed field ablation has fueled strong sales growth for the firm’s electrophysiology business over the past two years.

Spending on the tests, which analyze genetic material from both people and pathogens, rose 20% year over year in 2024, the ...

The purchase will give Medtronic a larger presence in the cath lab, with a tool to help diagnose and treat coronary artery ...

Amid the upheaval, Grail continued to run studies to assess the ability of its Galleri blood test to detect a range of ...

Abbott needs to conduct more performance testing to ensure its FreeStyle Libre devices are accurate, FDA inspectors found.

Stryker expects the robot, called Mako RPS, to bring in new customers, including more ambulatory surgery centers.

From M&A to surgical robotics and user fee negotiations, the medical device industry has a busy year ahead. Check out MedTech ...

The letter, which the FDA has not yet published, does not affect Beta Bionics’ ability to market, manufacture or distribute ...

With nine new procedures cleared for the da Vinci 5 robot, Intuitive’s strategy includes working with a limited number of U.S ...