ALACHUA, Fla.–(BUSINESS WIRE)–Neurotronics, a Nihon Kohden company, today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for its Sleep Analysis Module (SAM).SAM is a software-only medical device that includes a total sleep time (TST) algorithm. The algorithm analyzes a photoplethysmography (PPG) signal to estimate TST and aid health care professionals in the evaluation of sleep disorders.SAM represents the first FDA-cleared AI/ML-based sleep analysis al
