The U.S. Food and Drug Administration (FDA) has cleared the Wesper Lab system. The Wesper platform (formerly known as Tatch) assists trained personnel in the diagnosis of sleep apnea with data from a wireless patch component the user can apply to their body in the comfort of their own bed.
“Achieving FDA approval is an exciting and critical milestone to deliver on our mission to help everyone get better sleep,” says Amir Reuveny, PhD, CEO and co-founder of Wesper, in a release. “COVID-19 caused a behavioral shift and widespread acceptance of at-home diagnostics as both patients and medical professionals sought quality solutions that deliver reliable results. This shift, coupled with our new FDA approval, helps to remove the most burdensome physical, scheduling, and financial barriers that have traditionally challenged access to professional sleep diagnosis and treatment. We have the potential to improve the sleep and ultimately overall health of millions of patients.”
The Wesper Lab system was developed in close collaboration with practicing physicians, researchers, and other sleep experts.
The system includes:
- The Test: Wesper has distilled the power of a sleep lab into an easy-to-use wireless patch, allowing anyone to be diagnosed remotely and receive treatment for their sleep issues with the guidance of a sleep specialist.
- Sleep Report: The 3-inch wireless patch tracks the patient’s breathing dynamics, respiration quality, body positions, and an audio sample of snoring, distilling the data into a detailed sleep report.
- Sleep Specialist: Wesper Lab connects the patient virtually to a sleep specialist who analyzes the sleep report and provides a personalized sleep plan with treatment options for better sleep.
“As a sleep medicine professional with 40 years’ experience conducting both clinical and research sleep studies, I find Wesper to be a quantum leap forward in providing an easy yet reliable way for people who are concerned about their sleep to be evaluated,” says Sonia Ancoli-Israel, PhD, Wesper scientific advisor, in a release. “Home sleep recordings continue to be the wave of the future and devices such as Wesper are moving the field of sleep medicine forward.”
More than 15,000 people have turned to Wesper to get better sleep. The company anticipates a broader public launch of the FDA-approved version this summer.