WatchPAT One, a Fully Disposable Home Sleep Apnea Test Receives FDA Clearance

WatchPat One

 

WatchPat One
Image: Itamar Medical

Sleep apnea is a potentially severe sleep disorder, where breathing stops and starts repeatedly. A study has shown that people with severe sleep apnea may die prematurely up to three times more likely, and that risk increases if the sleep disorder is left untreated. If, even after a full night’s sleep, you snore loudly and feel tired, you may have a sleep apnea.

On March, a device named WatchPAT 300 Home Sleep Apnea Monitoring System posted on Wearable Technologies. In August 2018, WatchPat 300 received FDA clearance, and now the company’s new WatchPat One device has received US clearance. Food and Drug Authority (FDA).

The WatchPAT™ One is developed by Itamar Medical Ltd, an Israel-based company. Itamar is designing, manufacturing and selling non-invasive sleep apnea diagnostic medical devices with a emphasis on the cardiology industry , the company said in a news release.

WatchPAT One Home Sleep Apnea Test (HSAT) is the first and only fully disposable. The system incorporates advances in technology and comfort 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 the acquisition or management of our reusable WatchPAT products,” said Gilad Glick, Itamar Medical ‘s President and Chief Executive. “WatchPAT One offers the same simplicity to the patients and doctors, 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.”

Man sleeping
Image: Itamar Medical

Using the patented Itamar software, the tool can be connected to a smartphone. During the test, sleep study data are collected and sent automatically to Itamar’s secure server, CloudPAT™.

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