Banyan Biomarkers picked up the approval after showing the test reliably rules out intracranial lesions.

The FDA approved the use of Viz.AI’s artificial intelligence software that is designed to help quickly identify whether a patient has suffered a stroke.

The collaboration will leverage BC’s technology and Finnish health records to better understand atrial fibrillation patients.

Manufacturers including Abbott, Boston Scientific and Medtronic have argued that the ceiling makes their high-end products commercially unviable.

The results open the door to the noninvasive stratification of the fast-growing number of people with the liver disease.

Simplify Medical raised $23.25 million in a second round of series B funding to support two U.S. pivotal trials of its cervical artificial disc.

Abbott, Johnson & Johnson and 22 other organizations have told the FDA which medical device regulations they think the agency should scrap or revise.

The FDA and the Nuclear Regulatory Agency have cleared the use of NorthStar Medical’s RadioGenix system to produce technetium-99m.