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

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 ...

Called Flyrcado, the radiopharmaceutical could help improve cardiac imaging accuracy in patients with a high body mass index and women, the company said.

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.

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.

SYLKE® was developed by Dr. M. Mark Mofid, a faculty member of The Johns Hopkins School of Medicine and a practicing plastic surgeon for more than 20 years. Dissatisfied with outcomes, he conducted ...

The American Clinical Laboratory Association welcomed the reprieve but said long-term reform of the Medicare payment system is still needed.

The FDA plans to move the assays from higher-risk class III devices to class II, making them eligible for the 510(k) pathway.

Fred Moll, founder of surgical robotics firms Intuitive Surgical and Auris Health, participated in in the financing round, along with previous Auris investors.

Masimo’s leadership transition brings a two-year boardroom feud to a close, but questions remain about the path forward in the wake of CEO Joe Kiani’s exit. Kiani resigned after losing his board seat ...