Itamar Medical’s sleep apnoea test gets US regulatory clearance

10 June 2019 (Last Updated June 10th, 2019 12:47)

Israeli diagnostics device manufacturer Itamar Medical has secured US Food and Drug Administration (FDA) 510(k) clearance for the disposable home sleep apnoea test (HSAT), WatchPAT One.

Israeli diagnostics device manufacturer Itamar Medical has secured US Food and Drug Administration (FDA) 510(k) clearance for the disposable home sleep apnoea test (HSAT), WatchPAT One.

Based on the company’s WatchPAT technology, the test is designed for use in clinics and practices with limited resources, infrastructure or capital.

WatchPAT One can be linked to the WatchPAT device via the company’s smartphone app. The test collects sleep study data, which is automatically transmitted to Itamar Medical’s CloudPAT server.

After the completion of the test, WatchPAT’s True Sleep Time, Sleep Architecture and Central Plus algorithms are used to automatically generate a comprehensive report and send to the prescribing physician.

Itamar Medical president and CEO Gilad Glick said: “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.”

The company focuses on research, development, sales and marketing of non-invasive medical devices to diagnose respiratory sleep disorders.

Its portfolio includes Total Sleep Solution, designed to enable comprehensive sleep apnoea management in different clinical settings to optimise patient care and minimise healthcare costs.

In addition, Itamar Medical offers a WatchPAT home-use diagnostic device for sleep breathing disorders.

“WatchPAT One may have particular utility in the inpatient setting, where transmission of infection through reusable medical devices is a significant concern.”

This device, which can be worn like a wrist-watch, uses finger based physiology and technology to facilitate testing for obstructive sleep apnoea.

It operates on Peripheral Arterial Tone (PAT) signal, which measures the arterial volume changes at the fingertip. These changes indicate the sympathetic nervous system activation.

The company additionally provides the EndoPAT system for testing endothelial dysfunction and to assess cardiovascular diseases risk.