New York-based startup Paige.AI has gained the first disclosed breakthrough device designation from the U.S. FDA for the application of artificial intelligence (AI) in cancer diagnosis. Pathology is an obvious early place for AI in health care; it's imaging-heavy, and a segment where AI is already being integrated. In addition, there's a high degree of variability between pathologists in their assessments, while digital pathology slides are becoming more commonplace, and patient outcomes could be improved by more accurate, consistent pathology reports.

Shockwave Medical Inc. is aiming to establish a new standard of care for the minimally invasive treatment of atherosclerotic cardiovascular disease. Its intravascular lithotripsy (IVL) system uses sonic pressure waves to remove calcified plaque that narrows or blocks the blood vessels connected to the heart.