The US Food and Drug Administration (FDA) has granted Wesper, a sleep testing and management service provider, clearance for its next-generation home sleep testing device, which allows for clinical-grade longitudinal data collection over multiple nights to diagnose, titrate, and monitor treatment efficacy over time.
According to a press release by Wesper, the new device reduces the operational burden for professionals who need to screen, diagnose, or manage treatment.
“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,” says Wesper CEO Amir Reuveny in a press release. “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 company has been developing and refining its technology for several years, and its approach has been tested and validated through clinical trials, demonstrating quality data over traditional sleep testing methods, according to the company press release.
“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,” says Wesper chief medical officer Jeffrey Durmer, MD, PhD, in a press release.
The new clearance marks Wesper’s third FDA clearance.
Photo caption: The Wesper lab patches