Sleep apnea is a potentially serious sleep disorder in which breathing repeatedly stops and starts. A study showed that people with severe sleep apnea may be up to three times more likely to die prematurely, and that risk increases if the sleep disorder is left untreated. If you snore loudly and feel tired even after a full night’s sleep, you might have sleep apnea.
On March, Wearable Technologies reported on a device called WatchPAT 300 Home Sleep Apnea Detection System. WatchPat 300 received FDA clearance in August 2018, and now, the company’s new device WatchPat One received clearance from the U.S. Food and Drug Administration (FDA).
WatchPAT™ One is developed by an Israel-based company Itamar Medical Ltd. Itamar develops, manufactures and markets non-invasive diagnostic medical devices for sleep apnea with a focus on the cardiology market, the company said in a news release.
WatchPAT One is the first and only fully disposable Home Sleep Apnea Test (HSAT). The system incorporates the technology and comfort advances of WatchPAT 300, which received 510(k) clearance in August 2018 and was launched in March 2019.
“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 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.”
The device can be paired with a smartphone using Itamar’s proprietary app. Sleep study data are collected during the test and automatically sent to CloudPAT™, Itamar’s secure server.
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