Israeli medical technology company Itamar Medical has obtained the CE mark approval for its disposable home sleep apnea test (HSAT), dubbed WatchPAT ONE.

The CE mark allows commercialisation of its WatchPAT technology throughout Europe and other CE Mark geographies.

The company is focused on the development and commercialisation of non-invasive medical solutions for the diagnosis of respiratory sleep disorders.

Itamar Medical president and chief executive officer Gilad Glick said: “We are pleased to now have the opportunity to expand availability of our WatchPAT ONE in Europe, following rapidly growing adoption in the US.

“We are excited to be able to provide our cutting-edge technology to benefit physicians, as well as patients that are subject to social distancing, in light of the current COVID-19 related healthcare crisis. Importantly, our solution eliminates the need for return shipping, downloading, cleaning, and preparation, thus significantly reducing patient and staff exposure.”

WatchPAT ONE will deliver both ease of use and accessibility to patients

Itamar said that its WatchPAT ONE has been designed to deliver both ease of use and accessibility, where patients can pair the device to their smartphone using the company’s mobile App during their Home Sleep Apnea Test.

After the test is completed, the device will automatically transmit the data to the company’s secure CloudPAT server, and the prescribing physician will receive an automatically generated, comprehensive report.

The report is generated through the company’s WatchPAT’s True Sleep Time, Sleep Architecture and Central Plus algorithms. The patient is then able to dispose the WatchPAT device without any further action required.

WatchPAT ONE has been granted 510(k) approval by the US Food and Drug Administration (FDA) in July 2019, and is currently being commercialised in the US, Europe and Australia.

Glick added: “Additionally, we remain enthusiastic about WatchPAT ONE’s potential in the inpatient setting, where infection transmission through reusable devices is top of mind.”