A medical AI startup in Omaha, Neb., has received the FDA’s blessing to market software for diagnosing prostate cancer on MRI scans.

MRI technologists serving patients who have difficulty understanding English may need to budget additional scanner time—especially when image quality largely depends on patients’ compliance with breathing instructions.

The newly cleared device works like a traditional scale, but it captures more data than just the user's weight. 

“With increasing global rates of Lyme disease, providing a new option for people to help protect themselves from the disease is more important than ever,” says Annaliesa Anderson, PhD, senior vice president and head of vaccine research & development at Pfizer.

The FDA’s Center for Devices and Radiological Health (CDRH) has updated the status of two previously disaccredited mammography operations, rehabilitating the reputation of one while showing the other in limbo.

The presence of any or all of four factors can help ensure appropriate CT utilization in emergency settings: established diagnostic pathways, alternative test availability, involvement of specialists and feedback from referrers.

The deal brings together one of the biggest pharmaceutical companies in the United States with a biopharmaceutical company specializing in blood disorders.

News of the deal comes after reports that Signify Health is exploring strategic alternatives, including a sale.