Zdrowie i gospodarka · 01/06/2022
FDA Classifies Coronary Artery Disease Risk Indicator Using Acoustic Heart Signals as Class II Device
The FDA has classified the coronary artery disease risk indicator using acoustic heart signals as a Class II device, which will provide a reasonable assurance of safety and effectiveness, and enhance patients' access to innovative devices.
Source: Federal Register — Food and Drug AdministrationOpen original release →