27 August 2022

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FDA Clears Wesper Device For At-Home Sleep Apnea Diagnosis

Now from the comfort of your home, using Wesper can lead to real diagnoses for common sleep issues.

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Wesper - the first of its kind sleep health platform officially launched their Wesper Lab, the successor device to their successful Wesper Lite. The Wesper has been cleared by the U.S. Food and Drug Administration and has received its 510(K). Wesper’s sleep health platform assists trained personnel in the diagnosis of sleep apnea with data from a body-worn component that the user can apply in the comfort of their own bed.

Wesper has one of the highest degrees of correlation with PSGs compared to any other Type 3 device. The platform monitors several key parameters that you can’t find anywhere else, except sleep labs. In addition to sleep time, sleep efficiency, sleep latency, and heart rate, Wesper also reports on body positions throughout the night, airflow, respiratory effort, and snoring. Wesper supports and even encourages, multiple nights of testing at no additional cost. Evidence is growing that a single-night test does not account for multi-night variability and Wesper believes multi-night testing will become the standard of care, even for lab-based studies. 

Wesper is cloud based: the data is available for interpretation in near real-time, reducing delays and errors associated with equipment that must be returned to the clinic before an interpretation can take place. This is a major pain point for many of their customers. Wesper will connect users virtually to a sleep specialist – putting them on the track to personalized treatment options and better sleep, once and for all. Wesper has distilled the power of a sleep lab into an easy-to-use patch, allowing anyone to be diagnosed and get treated for their sleep issues with the guidance of a sleep specialist. 

Wesper is focused on transforming the lives of anyone with chronic sleep problems and those with suspicions about living with a sleep disorder, such as sleep apnea. Sleep apnea is one of the most common sleep disorders in the United States, with approximately 54M adults suffering from the condition. 

Untreated sleep apnea increases the risk of dying from cardiovascular disease 5-fold, as well as elevating the risk for cancer and Alzheimer's disease. Wesper’s sleep-lab-in-a-patch solution was developed in close collaboration with practicing physicians researchers and the nation's leading sleep experts and brings the highest levels of accuracy to people’s homes. 

“Improving your sleep used to be a very lonely and complicated process and we are here to change that,” says Dr. Amir Reuveny, CEO and co-founder of Wesper “We are committed to our users every step of the way to getting high-quality sleep.”

About Wesper

For individuals who strive to live healthier lives, Wesper is at the forefront of health technology - providing users with the potential for better sleep through an innovative platform that integrates optimum comfort and virtual guidance. Wesper’s commitment to comfort, accessibility, and technological advancement enables it to focus on building healthcare tools tailored to customers’ unique needs. Wesper has redefined sleep health by creating a seamless path to personalized solutions based on granular, clinical-grade data. Established in 2017 and headquartered in NY, as a spinout of Cornell Tech University, Wesper has recently received funding from leading VCs and employs approximately 20 distinguished professionals. With media outlets such as Forbes, TED & TechCrunch taking notice, Wesper is establishing a strong foundation for itself and is looking forward to improving the lives of billions around the globe.

Source: https://wesper.co/