ZOLL® announced that PolySenseTM, a new set of accessories that expands the WatchPAT® 400 from a standard home sleep apnea test (HSAT) to home polysomnography (home PSG), has received 510(k) clearance from the U.S. Food and Drug Administration (FDA).
Built from customer feedback, PolySense is designed for simplicity, scalability and speed. Easy self-applied patches and interchangeable modules make fully self-applied studies at home possible. Head, cardiac and leg patches record EEG, EOG, EMG, ECG and leg movement, enabling one platform to scale from routine HSAT to advanced testing without compromising simplicity. Immediate physician access to results upon test completion allows an expedited time to diagnosis. If a physician deems advance sleep testing is needed for a patient, the WatchPAT 400 with the full PolySense kit can be used to measure up to 11 of the channels and analyze 9 of the parameter categories referenced by the AMA CPT Assistant, effective January 1, 2027
