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.