Itamar Medical Receives CE Mark Approval for its WatchPAT™ ONE, the First Fully Disposable Home Sleep Apnea Test
GlobeNewswire GlobeNewswire•May 4, 2020 Complete, home-based solution for diagnosing respiratory sleep disorders approved for commercialization in Europe and other CE Mark geographies
CAESAREA, Israel, May 04, 2020 (GLOBE NEWSWIRE) -- Itamar Medical Ltd. (NASDAQ and TASE: ITMR), a medical technology company focused on the development and commercialization of non-invasive medical solutions to aid in the diagnosis of respiratory sleep disorders, today announced receipt of CE mark approval for the Company’s WatchPAT™ ONE. The CE mark allows Itamar to expand commercialization of the latest innovation of its WatchPAT technology and the first fully disposable Home Sleep Apnea Test (HSAT), throughout Europe and other CE Mark geographies.
“We are pleased to now have the opportunity to expand availability of our WatchPAT ONE in Europe, following rapidly growing adoption in the US,” said Gilad Glick, President and Chief Executive Officer of Itamar Medical. “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. Additionally, we remain enthusiastic about WatchPAT ONE’s potential in the inpatient setting, where infection transmission through reusable devices is top of mind.” About WatchPAT ONE
WatchPAT ONE was designed to deliver both ease of use and accessibility. With WatchPAT ONE, patients simply pair the WatchPAT device to their smartphone using Itamar’s proprietary App during their Home Sleep Apnea Test. Once the test is complete and the data is automatically transmitted to Itamar’s secure CloudPAT™ server, the prescribing physician receives an automatically generated, comprehensive report based on 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 received 510(k) clearance from the U.S. Food and Drug Administration (FDA) in July 2019 and is currently available in the U.S., Europe and Australia. https://finance.yahoo.com/news/itamar-medical-receives-ce-mark-100010491.html