CHELMSFORD, Mass.–ZOLL Medical, an Asahi Kasei company that develops medical devices and software solutions, has received clearance from the U.S. Food and Drug Administration (FDA) for its new PolySense accessories, which expand the capabilities of its WatchPAT 400 system to support more advanced sleep testing at home.
The FDA’s 510(k) clearance allows the WatchPAT 400, previously used for home sleep apnea testing, to perform home polysomnography, a more comprehensive form of sleep testing that traditionally requires patients to undergo monitoring in a specialized sleep laboratory.
The new PolySense accessories include self-applied patches for the head, chest and legs that collect additional physiological data during sleep. These sensors measure brain activity, eye movements, muscle activity, heart activity and leg movements, allowing physicians to evaluate a broader range of sleep-related conditions.
The system uses electroencephalography (EEG), electrooculography (EOG), electromyography (EMG) and electrocardiography (ECG) to collect information that can help healthcare professionals assess sleep patterns and potential disorders.
When equipped with the full PolySense kit, the WatchPAT 400 can measure up to 11 channels and analyze nine categories of physiological parameters referenced in the American Medical Association’s CPT Assistant guidance, effective January 1, 2027.
According to ZOLL, the expanded platform allows healthcare providers to select between routine home sleep apnea testing and more advanced diagnostic studies using the same underlying system.
The accessories are designed to be applied by patients themselves, eliminating the need for technicians to attach monitoring equipment in a sleep laboratory for these studies.
The system also allows physicians to access test results immediately after a study is completed, potentially shortening the time required to evaluate patients and determine appropriate treatment.
“Everything we build starts with our customers and their patients,” said Dr. Shiri Shneorson, President of the Itamar division at ZOLL. “Our customers asked for a simple way to offer advanced sleep testing at home, and PolySense delivers it on the WatchPAT 400 platform they already know. Its self-application design helps practices run more home PSG studies efficiently. We are excited to bring it to market, and we will keep innovating around what our customers and their patients need.”
Traditional home sleep apnea tests generally focus on identifying sleep-disordered breathing, while polysomnography collects additional information that can help physicians investigate more complex sleep conditions.
By incorporating additional sensors into the WatchPAT platform, ZOLL aims to make more comprehensive sleep evaluations available outside hospital and laboratory settings.
Alan Schwartz, M.D., a specialist in Pulmonary Critical Care and Sleep Medicine at the University of Maryland Medical System, said the expanded capabilities could help physicians evaluate patients who require more detailed testing.
“Some of our patients need an advanced sleep study to address several diagnostic possibilities, rather than a standard home sleep apnea test. Until now, a full lab-based polysomnogram was required. WatchPAT 400 and its PolySense accessories will allow us to close that gap with a home study. PolySense and its companion WatchPAT 400 will provide additional sensors that will extend our ability to choose the right study for each patient at home,” Schwartz said.
ZOLL said the PolySense accessories are scheduled to become available to customers in the United States in early January 2027, with several purchasing options planned.
The technology was developed by ZOLL Itamar, a division of ZOLL Medical specializing in home sleep apnea testing and sleep management solutions.
The division’s WatchPAT devices and related services are designed to help healthcare providers diagnose sleep-disordered breathing and manage patients undergoing sleep evaluations outside traditional clinical settings.
The FDA clearance expands ZOLL’s home sleep testing portfolio as healthcare providers explore alternatives to laboratory-based diagnostic procedures for patients who may benefit from more convenient testing options.
