510(k) Clearance Granted To ResApp Sleep Apnea Detection App

The US Food and Drug Administration has granted clearance to ResApp Health’s 510(k) app. The SleepCheckRx app screens users for moderate to severe sleep apnea by listening to recordings of their breathing and snoring. The regulatory clearance will only apply to the iPhone version. However, ResApp has stated that they are committed to developing an android version. 

In the U.S. alone, approximately 20 million American adults live with sleep apnea. Despite the high number, the majority are unaware of their condition. The new app will help provide physicians with the opportunity to evaluate their patients effectively. To acquire access to the app’s features, patients will require a prescription from their healthcare provider. The prescription will provide patients with a code to access the iPhone app store and download SleepCheckRx. The app will then record the patient’s sound while they sleep, which will be uploaded to an online portal accessible by the healthcare providers. 

A study was conducted comparing ResApp’s machine learning algorithms to traditional polysomnography to find indicators of obstructive sleep apnea involving more than 200 patients in their own homes. It study found that the app had an accuracy of at least 83 percent in identifying sleep apnea at different severity levels. In terms of sensitivity, the results ranged from 73 percent for mild cases to 90 percent for severe cases of sleep apnea. While results from polysomnography represent the benchmark for sleep apnea diagnosis, the tests can be pricey and are not widely available to the American population.

The FDA approval comes at an excellent time for ResApp as Pfizer’s acquisition of the tech firm continues. Previously, Pfizer had intended to acquire ResApp through a proposal largely based on the company’s ResAppDx, an app which helps diagnose respiratory conditions in individuals by examining their breathing sounds and coughing. Pfizer had offered approximately $74 million. However, since then Pfizer has increased their offer to approximately $86 million. A meeting will take place in August, where stakeholders will be asked to vote on the company’s future. ResApp’s directors have recommended stakeholders to vote in favor of the acquisition.