Regulatory Roundup: FDA clears AI-powered Apple Watch competitor, grants breakthrough designation to new heart failure device

Ancora Heart AccuCinch Ventricular Restoration System heart failure FDA
Ancora Heart’s AccuCinch Ventricular Restoration System. Image courtesy of Ancora Heart.

Ancora Heart received the FDA’s breakthrough device designation for its AccuCinch Ventricular Restoration System, a new minimally invasive transcatheter device designed for the treatment of heart failure.