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. Intuitive created the robotic surgery ...

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.

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 ...

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

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 ...