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Home » ResApp’s SleepCheckRx Receives 510(k) Clearance
ResApp’s SleepCheckRx Receives 510(k) Clearance
The FDA granted 510(k) clearance to ResApp Health’s SleepCheckRx prescription-only software device.
SleepCheckRx screens for the risk of moderate-to-severe obstructive sleep apnea by analyzing breathing and snoring sounds recorded on an iPhone. In a clinical trial, the software correctly identified 89.3 percent of patients with the condition, the company said.
Because the app is only available through a prescription, those who get a prescription will be given a code to use at the App Store. The test results will be uploaded to a healthcare provider portal.
ResApp said it also plans to seek FDA’s 510(k) clearance for use of the software on Android devices.
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