Since the 1960s, cardiologists have prescribed portable card…
Since the 1960s, cardiologists have prescribed portable cardiac monitoring devices for patients to wear at home for short periods to help diagnose heart problems. Advanced Medical Assistant, a company focused on software as a medical device (SaMD), has developed an artificial intelligence tool to be used with these portable devices which would analyze the heart data in real time and immediately report certain irregularities to the patient’s doctor. The device would also collect heart data to help improve the algorithms used by the tool. As the Chief Compliance Officer, you recommend that: