Sleep diagnostics company Itamar Medical Ltd has received 510(k) clearance from the US Food and Drug Administration for WatchPAT One, the latest device using its WatchPAT technology—and the first fully disposable home sleep apnea test (HSAT). WatchPAT One incorporates the technology and comfort features of WatchPAT 300, which received 510(k) clearance in August 2018 and was launched in March 2019.s
“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,” says Gilad Glick, president and CEO of Itamar Medical, in a release. “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.”
With WatchPAT One, patients pair the WatchPAT device to their smartphone using Itamar’s proprietary app. Sleep study data are collected during the test and automatically sent to CloudPAT, Itamar’s secure server. Once the test is complete, a report using WatchPAT’s true sleep time, sleep architecture, and Central Plus algorithms is automatically generated and sent to the prescribing physician. The patient then disposes the WatchPAT device. WatchPAT One utilizes the same reimbursement codes as Itamar Medical’s other outpatient WatchPAT studies.
WatchPAT One will be unveiled at SLEEP 2019. Meeting attendees can learn more about WatchPAT One and the WatchPAT family of products and services by visiting Booth #916 at 10:00 CDT on June 10.
My thoughts… first is ‘great! More non-recyclable plastics and tech to put in landfills 🙁 second, great to have a home based sleep apnea test, but then when the diagnosis occurs, patient still needs to go into sleep lab to have crap/bipap set up. My mother is in that loop right now. And it is over a two month wait for sleep
Lab time! Can’t even purchase a machine out right. Durable Medical Goid company won’t sell unless it is set up in the sleep lab.
So while it may be useful to have a home based disposable option for use “where transmission of infection through reusable medical devices is a significant concern”, the long term cost to the environment and additional stress on the patient plus addition billing to insurance seems extremely excessive and expensive in the long run!
We are users of the Watch PAT diagnostic HST. We’ve been in business for 25 years. We are also experts in CPAP treatment. Our web site explains the process. We do fittings and UPS devices using our telehealth pathway. We work with your primary care M.D. and one starts therapy in weeks not months. Email me if you would like to discuss. We also promise compliance.
Check if your mom is a candidate for auto-CPAP. If yes, she may not need to go to the sleep lab.
Can it be reused on the same patient to gauge
efficacy of alternative therapies?
The proper method is to monitor if the equipment is doing its thing, so the equipment must be able to be reused on the same patient.
Id also like to know if this device can be reused for the same patient. I dont see a reason why not? One time use for so much material is just not worth all the negative effect to the environment.