WatchPAT One, a Fully Disposable At-Home Sleep Apnea Test, FDA Cleared

Itamar Medical, a firm based in Israel, won FDA clearance for its brand new WatchPAT One system for at-home sleep apnea testing. The system is based on the previously cleared WatchPAT 300 device, but it’s fully disposable and is therefore is not reused between patients, helping to prevent any infections.

The WatchPAT One pairs with the patient’s smartphone via a Bluetooth connection, and a compatible app from Itamar is used to relay data from the device to the patient’s physician once the sleep study is over.

The company believes that many sleep clinics will be able to save money thanks to the device being disposable, as cleaning and preparation, or shipping the devices back and forth, will not be necessary. The process is simplified and clinicians simply open a new WatchPAT One and put it on their patient.

“WatchPAT One is ideally suited for clinics and practices that recognize the value of HSAT but have limited resources, infrastructure or capital to invest in acquiring or managing our reusable WatchPAT products,” said Gilad Glick, President and Chief Executive Officer of Itamar Medical. “WatchPAT One offers patients and physicians the same simplicity, accuracy and reliability as WatchPAT 300 without the need for return shipping, downloading, cleaning or preparation for the next study. We expect the availability of a disposable WatchPAT system will improve patient access by increasing the number of physicians able to offer our cutting-edge technology to their patients. Additionally, as a disposable HSAT, WatchPAT One may have particular utility in the inpatient setting, where transmission of infection through reusable medical devices is a significant concern.”