At CES 2025, deeptech startup APNEAL unveils the first-ever medical device technology that enables advanced sleep examinations at home using nothing more than a smartphone. This AI-powered app transforms ordinary smartphones into accessible diagnostic tools, eliminating the need for sleep clinics or complex equipment for most patients.
With nearly 80% of sleep apnea cases undiagnosed, APNEAL offers a simple, affordable, and reliable solution to a critical public health issue. People no longer have to spend a night wired to sensors in a sleep clinic or purchase costly medical devices. With APNEAL, all you need is your smartphone!
Sleep Apnea: A Major Public Health Issue
What if detecting sleep apnea was as effortless as sleeping soundly, thanks to a simple app? Sleep apnea, a major public health issue, affects more than 900 million people globally, with over 80% of cases undiagnosed. Women are even more underdiagnosed, with over 90% of cases missed. In the U.S., 26% of adults aged 30–70 are affected, partly due to the obesity epidemic.
This silent killer is a significant risk factor for severe conditions such as cardiovascular disease, strokes, diabetes, cognitive disorders, cancer and even road accidents caused by drowsiness. After cancer, diabetes, and coronary diseases, sleep apnea ranks fourth among the biggest health system cost drivers.
Yet, current diagnostic methods remain cumbersome, involving long, expensive, and uncomfortable sleep studies conducted in specialized clinics or requiring complex and costly home devices.
A Revolutionary Solution Within Reach
APNEAL transforms an ordinary smartphone into a medical-grade testing tool for sleep apnea. How does it work? The user attaches their smartphone to their chest with an adhesive strip (available at pharmacies) and activates the app in airplane mode.
During the night, the phone’s sensors—accelerometer, gyroscope, and microphone—capture respiratory movements, heartbeats, and sounds of breathing. These data points are analyzed by artificial intelligence, delivering an unprecedented 90% accuracy in categorizing affected individuals compared to standard clinical tests like polysomnography.
Results are then made available to healthcare professionals through a dedicated dashboard, streamlining the diagnostic process and enhancing patient care.
Severin Benizri, CEO and co-founder of APNEAL, explains: “Our goal is to radically simplify the diagnostic journey for sleep apnea. By leveraging advanced smartphone sensors and artificial intelligence, we’re making this crucial step accessible to everyone, with reliability comparable to dedicated sleep examination hardware.”
Simple, Accessible, and Clinically Accurate
APNEAL democratizes sleep apnea detection, offering a game-changing diagnostic solution that is:
As natural as sleeping: With APNEAL, there’s no need for electrodes, wearables, or complex medical devices. A simple adhesive and your smartphone are all it takes. Users can maintain their nightly routine without any disruptions and sleep in any position comfortably.
More precise than smartwatches: Unlike wearables that detect only severe apnea cases, APNEAL captures even mild and moderate symptoms providing detailed reports with actionable insights for intervention.
An alternative to hospital tests: Say goodbye to spending nights in hospitals wired to multiple devices. APNEAL provides a complete and reliable diagnostic solution from the comfort of your home, eliminating the stress, discomfort, and costs of traditional lab tests.
Highly accurate: The app uses the smartphone’s microphone and sensors, such as the accelerometer and gyroscope, capturing up to 3,000 data points per second. These tools record intricate respiratory and positional changes across six axes, which are analyzed by AI to deliver clinical-grade results.
Healthcare professional-ready: APNEAL doesn’t just benefit patients; it’s designed with medical professionals in mind. The data collected is presented in intuitive, detailed reports that integrate seamlessly with existing medical systems. This simplicity empowers doctors to diagnose quickly and provide better care, making this innovation widely accessible.
Trusted Medical Validation and Certification in Progress
APNEAL has already demonstrated its efficacy in a preliminary study at Bichat Hospital with 50 patients, achieving 90% accuracy in categorizing affected individuals. The next step is obtaining CE marking and FDA approval.
APNEAL is currently conducting one of the largest sleep studies ever conducted for a medical device validation, involving 1000 patients across twenty European centers in France, Germany, and Spain.
This study will enable CE marking and FDA approval by 2025, with full-scale deployment planned for 2026. Real-life and health economics studies with pharmacies, insurance companies, and clinical research organizations will begin in early 2025.
In addition, APNEAL leads a European EIT Health Flagship consortium (total budget: €2.2M) alongside Air Liquide, a European leader in sleep apnea treating 1.3M patients across 25 countries.
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