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.

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 ...

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

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.

The latest investment extends an earlier funding round, bringing the total raised to $82 million. Novo Holdings, the controlling shareholder of Novo Nordisk, joined returning investors. Route 92 has ...

The Food and Drug Administration has proposed changing antigen, antibody and nucleic acid-based hepatitis B virus (HBV) assays to a lower-risk classification. Currently, the tests are class III, or ...

Recalled heart devices often lack clinical testing, researchers found in a study published last week in the Annals of Internal Medicine. Heart devices account for one-third of Class I recalls, the ...

The Protecting Access to Medicare Act (PAMA) of 2014 tied laboratory payment rates to market data for diagnostic tests, resulting in three rounds of reimbursement cuts. ACLA and other industry groups ...