Itamar gets FDA-clearance for disposable wearable that tests for sleep apnea

By Jonah Comstock
Share

Caesarea, Israel-based Itamar Medical received FDA 510(k) clearance last week for a new disposable home sleep apnea test (HSAT) called WatchPAT One.

The device is smartphone-connected; patients pair the wearable to their phone before sleeping with the device, which straps around the wrist but also includes a sensor that goes over the tip of the finger and another that affixes to the chest, both physically connected to the wrist strap by wires.

Like previous WatchPAT devices, it can read heart rate, oximetry, actigraphy, body position, snoring and chest motion to test for obstructive sleep apnea, in addition to peripheral arterial tone (PAT) signal, the proprietary signal for which the product line is named. That data is analyzed in the app, which sends a report to the patient's physician via the cloud.

Once a patient has slept with the device, they can dispose of it rather than needing to send it back or manually download data.

The device was unveiled today at SLEEP 2019, the annual meeting of the Sleep Society in San Antonio.

WHY IT MATTERS

While disposable wearables might seem like a strange idea, in the area of home sleep apnea testing, where the device doesn't need to be worn more than once, they make sense.

"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,” Gilad Glick, president and CEO of Itamar, said in a statement. “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. 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.”

WHAT'S THE TREND

This clearance follows the approval of WatchPAT 300 back in 2017.

Sleep apnea detection and diagnosis is an area of growing interest in digital health. While ResMed is one of the larger players in the space generally — and has explored digital solutions in other contexts — its current diagnostic offering, ApneaLink Air, is not smartphone-connected.

Plenty of smaller players have entered the ring, however: among them forehead-worn sensor Beddr, an app from ResApp that uses the phone's microphone and no device; and an AI-powered algorithm for the Apple Watch from Cardiogram.

Even Withings seemed to be signalling a move in this direction with an update released in March.