New PolySense™ Accessories for WatchPAT® 400 Receive FDA Clearance

• PolySense™ accessories expand the ZOLL WatchPAT^® 400 from a home sleep apnea test (HSAT) to home polysomnography (home PSG)
• Simple, self-applied head, cardiac and leg patches and WatchPAT 400 provide versatility, allowing for a scalable range of routine to advanced sleep testing at home
• With the full PolySense kit, the WatchPAT 400 is capable of measuring up to 11 channels and 9 parameter categories referenced by the AMA CPT Assistant, effective January 1, 2027
• PolySense will be available in the U.S. in early January 2027

CHELMSFORD, Mass.--(BUSINESS WIRE)--ZOLL^®, an Asahi Kasei company that manufactures medical devices and related software solutions, announced today that PolySense™, 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.

“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.”

“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,” said Alan Schwartz, MD, Pulmonary Critical Care, Sleep Medicine, University of Maryland, Medical System.

PolySense will be available to customers in the U.S. in early January 2027, with flexible acquisition options. For more information, call 888-748-2627 or visit www.itamar-medical.com.

ZOLL Itamar, a division of ZOLL Medical, develops home sleep apnea testing and sleep management solutions for patients and healthcare professionals. Its WatchPAT^® home sleep tests and related services help providers diagnose sleep-disordered breathing at home.

About ZOLL

ZOLL, an Asahi Kasei company, develops and markets medical devices and software solutions that help advance emergency care and save lives, while increasing clinical and operational efficiencies. With products for defibrillation and cardiac monitoring, circulation enhancement and CPR feedback, supersaturated oxygen therapy, data management, ventilation, therapeutic temperature management, and sleep apnea diagnosis and treatment, ZOLL provides a comprehensive set of technologies that help clinicians, EMS and fire professionals, as well as lay rescuers, improve patient outcomes in critical cardiopulmonary conditions. For more information, visit www.zoll.com.

About Asahi Kasei

Asahi Kasei is a diversified global company that contributes to life and living for people around the world. Since its foundation in 1922, with businesses in ammonia and cellulose fiber, Asahi Kasei has consistently grown through proactive portfolio transformation to meet the evolving needs of every age. With 50,000 employees worldwide, the company contributes to sustainability by providing solutions to the world’s challenges across its three business sectors: Healthcare, Homes, and Material. For more information, visit https://www.asahi-kasei.com/.

Copyright © 2026 ZOLL Medical Corporation. All rights reserved. ZOLL, Itamar, WatchPAT and PolySense are trademarks or registered trademarks of ZOLL Medical Corporation and/or its subsidiaries in the United States and/or other countries. Asahi Kasei is a registered trademark of Asahi Kasei Corporation. AMA is a trademark or registered trademark of the American Medical Association. All other trademarks are the property of their respective owners.