Itamar Medical (TASE:ITMR) said that its WatchPAT One fully disposable home sleep apnea test has received FDA 510(k) clearance.
The device may save clinics time and money because it does not need return shipping, downloading, cleaning or preparation for the next study, according to Caesarea, Israel-based Itamar.
“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,” said Itamar Medical president and CEO Gilad Glick in a news release. “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.”
Patients pair the WatchPAT device to their smartphone using the company’s app, which collects and sends sleep study data to Itamar’s secure server. The company sends the report to the prescribing physician. WatchPAT One uses the same reimbursement codes as Itamar Medical’s other outpatient WatchPAT studies.
Itamar Medical launched WatchPAT One this week at SLEEP 2019, the annual meeting of the Sleep Society, which runs through June 12 in San Antonio, Texas.
Itamar Medical’s WatchPAT 300 received 510(k) clearance in August 2018 and was launched in March 2019. The company, which also makes heart failure diagnostic devices, announced in January that it stood to raise nearly $12 million in a private placement with American and Israeli investors.