Wearable Sleep Monitor Receives Third FDA Clearance

Wesper (New York, NY) announced that its wearable sleep monitoring platform has received an additional FDA clearance for the ongoing collection of physiologic and environmental data associated with sleep over multiple nights in response to therapeutic interventions. Wesper previously had received clearance for its wearable sleep monitoring platform to provide data associated with sleep to aid clinicians in the diagnosis of sleep apnea. The Wesper platform consists of patches to be applied by patients along with a pulse oximeter which provide data wirelessly to clinicians, an app that can be used by patients to access data on sleep outcomes and which can be used by individuals to log additional personal and lifestyle factors that may affect sleep, and a portal that can be used by clinicians to communicate with patients, generate reports, and make adjustments to sleep treatments. Data collected by the Wesper platform include sleep position, heart rate, sleep duration, SpO2, airflow, pressure, snoring, and more.

According to Wesper’s Chief Medical Officer, Dr. Jeffrey Durmer, “With this most recent FDA clearance, Wesper can now provide clinical data on a patient's real-time sleep physiology in response to treatment, their adherence to therapy, or the need for additional or combination therapies to resolve sleep issues over time.”

As many as 50 to 70 million Americans have a sleep disorder. The Wesper device can help clinicians accurately diagnose and monitor sleep conditions in home settings without the need for a lab study.