Wesper, a sleep testing and management service provider, received a third clearance from the U.S. Food and Drug Administration (FDA) for its next-generation device. The new device positions Wesper as the first and only platform that allows for important clinical-grade longitudinal data collection over multiple nights to diagnose, titrate, and monitor treatment efficacy over time. The new device comes at an affordable cost and dramatically reduces the operational burden for professionals who need to screen, diagnose, or manage treatment.
Sleep testing is a critical component in the diagnosis and treatment of sleep disorders such as sleep apnea, as well as reducing the risk of comorbid conditions such as heart disease or dementia. Traditionally, each patient must undergo a sleep test, which can be time-consuming, expensive, and wasteful. Wesper's new approach eliminates these issues by enabling the reuse of a single sleep test for multiple patients.
"Our commitment to innovation and quality is paving the way for sleep clinics to provide a better experience to their patients with high-fidelity data and insights," said Wesper's CEO, Amir Reuveny. "Our technology revolutionizes sleep care by making sleep management more accessible and affordable for patients while also reducing waste and lowering costs for healthcare providers."
The FDA clearance is a significant milestone for Wesper, which has been developing and refining its technology for several years. The company's approach has been rigorously tested and validated through clinical trials, demonstrating quality data over traditional sleep testing methods.
"Historically, an obstacle for sleep healthcare has been the ability to generate clinically reliable measures of sleep physiology in a patient's home while managing one or more therapies. 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," said Chief Medical Officer Dr. Jeffrey Durmer.