Device for Sleep Disorders Cleared
Itamar Medical’s new Watch-PAT200 was cleared for marketing in the United States by the FDA. This system is designed to assess patients with breathing disorders related to sleeping, including diagnosis of disease and evaluation, as described by FDANews.
The device is similar to a watch. It is attached to a patient’s wrist which is connected to a probe on the finger. The device then records physiologic parameters from the finger while patients are sleeping.
This device tracks the peripheral arterial tone (PAT) signal. Clinical data collected with the system includes oxygen desaturation levels, sleep phases (including REM), apnea-hypoapnea index, and sleep time.
This information is then reviewed to determine underlying disease. Data also can be used to either rule out or confirm a suspected diagnosis. Itamar published news of the premarket notification on their website.
An advantage of this system is the minimal connections required to collect diagnostic data. Most solutions in this diagnostic area require placement of multiple sensors and electrodes on patients including the torso, abdomen, and head and sometimes a nasal cannula. This new Watch-PAT200 can be used in a patient’s own home, which is more convenient than testing in the sleep lab.
August 14, 2008 Related topics: Pulmonary, Diagnostic