Itamar Medical, a non-invasive medical devices provider, announced that the US Food and Drug Administration (FDA) has granted 510(k) clearance for its WatchPAT One, a fully disposable Home Sleep Apnea Test (HSAT).
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The new device is expected to expand the WatchPAT access to additional sleep centres through reducing infrastructure needs, eliminating capital requirements, and reducing infection risk for sleep apnea testing.
Itamar said that the new WatchPAT One is a PAT-based, home-use diagnostic device for sleep breathing disorders, and is designed based on the technology and comfort advances of WatchPAT 300.
In August 2018, the company received FDA 510(k) clearance for the WatchPAT 300 and has launched the product in March 2019.
Itamar Medical President and Chief Executive Officer Gilad Glick said: “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.
“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.”
WatchPAT One enable patients pair the device to their smartphone using an app provided by the company, which collects the sleep study data during the test and automatically sends to the company’s secure server CloudPAT.
After the completion of test, the device automatically generates a comprehensive report using WatchPAT’s true sleep time, sleep architecture and central plus algorithms and sends it to the prescribing physician.
Itamar said that WatchPAT One makes use of the same reimbursement codes similar to its other outpatient WatchPAT studies, and once the use of WatchPAT device is over, the patient can dispose the device.
Itamar is planning to unveil the WatchPAT One device at the annual meeting of the Sleep Society SLEEP 2019, to be held in San Antonio, Texas, US.
Glick added: “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.”