GAN YAVNE, Israel (June 3, 2022)--SleepX, a subsidiary of AppYea, announced it has received approval from the Helsinki Committee to begin its planned clinical trial on the SleepX PRO application.
This follows the company’s recent update that it intends to test the SleepX Pro application at a hospital sleep lab. The trial is the first step towards applying for Food and Drug Administration approval under the first-of-its-kind medical device category for contactless detection of sleep apnea to be performed through the artificial intelligence analysis of breathing during sleep.
SleepX Pro, which is designed to diagnose sleep apnea using only a smartphone, requires no physical contact with the subject.
“Poor sleep is associated with the compromised immune system, heart problems, reduce physical and mental performance, mood problems, obesity and many other health problems”, said Neil Kline, founder & former CEO of the American Sleep Association and a board member of AppYea. “Unfortunately, most people with sleep disorder breathing problems, like sleep apnea, are undiagnosed and untreated. Our goal in this unique technology is to raise the awareness to the problem and to improve people’s they can live healthier and more fulfilling lives.”
“SleepX PRO makes for a unique, quick and friendly diagnosis tool that will prevent subjects from having to spend nights at sleep labs while saving the healthcare system and insurance companies hundreds of millions of dollars”, said SleepX President and CEO Boris Molchadsky, who is also chair at AppYea. “We plan to make our diagnosis solution highly accessible so people get tested easily."
SleepX is an Israeli research and development company recently acquired by AppYea. The company's technology is protected by several international patents and the company plans to start serial production in 2022.