Exact Sciences expects to launch the updated test, which has higher specificity than its predecessor, with Medicare coverage and guideline inclusion in 2025.

Smiths has grappled with multiple quality issues and recalls over the past few years. Two recent recalls focus on problems with portable ventilators.

The company said it received 170 reports of hyperglycemia and 11 reports of diabetic ketoacidosis in the U.S. that could be linked to the problem.

The settlement terms are confidential, BD said. The company disputes the lawsuit’s allegations and backs its product designs.

Philips is asking customers to immediately install a software update to address several new and previously reported safety issues, the FDA said.

As access challenges to the site continue, Baxter has limited purchases of certain products to avoid stockpiling, manage inventory and minimize disruption to patient care.

After making nearly $550 million worth of acquisitions in the past few years, the medical device contract manufacturer will use proceeds from the sale to pay down debt.

The FDA has now approved the 3D elements, which feature a 50-degree wide-angle technology. Siemens said the angle is the widest available. The mammography system has a scan time of around five seconds ...

More than 2,500 people work at the facility, which is Baxter’s largest manufacturing site. The company is still working to fully assess the damage.

PSN Labs called for a jury trial, claiming Philips is attempting to deflect attention away from its own “failures, negligence, concealment and recklessness.” ...

The software turns coronary CT angiography images into 3D models that quantify and classify plaque morphology to improve predictions of heart attack and stroke risk.

Regulators say Medicare needs more data and oversight to avoid fraud and misuse. Digital health advocates argue the service is still crucial for managing chronic conditions.