PranaQ® Receives FDA 510(k) Clearance for TipTraQ, an AI-Enabled Home Sleep Apnea Test
[New York, Feb 18, 2025] – PranaQ, a pioneer in AI-powered sleep diagnostics, has received U.S. Food and Drug Administration (FDA) 510(k) clearance for TipTraQ, a single-point-of-contact home sleep apnea test wearable that provides comprehensive sleep and respiratory insights with minimal sleep disruption.
“Receiving FDA clearance for TipTraQ is a significant milestone in our mission to revolutionize sleep diagnostics and monitoring,” said Jerry Chen, CEO of PranaQ. “With millions of undiagnosed sleep apnea sufferers, TipTraQ enables accessible and reliable at-home testing, helping more people receive timely diagnosis and treatment.”
With FDA clearance, PranaQ is set to launch nationwide, making TipTraQ available to sleep clinics, telehealth providers, and hospitals.
Comprehensive Sleep Insights at Your Fingertips
TipTraQ is a compact wearable that uses advanced biosensors and AI algorithms to detect sleep apnea events and analyze sleep architecture with clinical-grade accuracy. The device enables patients to undergo testing from the comfort of their homes, reducing barriers to diagnosis and improving patient compliance.
The wearable includes a charging case and supports remote data transfer, so patients don’t need to return the device after each night. This makes it ideal for seamless multi-night testing and continuous treatment monitoring, giving healthcare providers a comprehensive and longitudinal view of patients’ sleep at home.
In addition to its comprehensive sleep parameters, TipTraQ is cleared for its ability to identify sleep apnea severity cutoffs of 5 (mild), 15 (moderate), and 30 (severe) under both the AASM 1A and 1B rules, delivering actionable insights to support well-informed clinical decisions.
Validated Through Clinical Studies
TipTraQ’s accuracy is backed by multiple clinical trials across North America and Asia, including Duke University Hospital and the University of California, San Francisco.
The device has demonstrated excellent sensitivity and specificity compared to gold-standard polysomnography (PSG) tests, reinforcing its reliability for sleep apnea detection. Additionally, TipTraQ has achieved exceptional SpO₂ accuracy across all skin tones. By addressing a well-documented limitation in pulse oximetry, it ensures consistent and reliable nocturnal oxygen monitoring, further enhancing its effectiveness in diagnosing sleep apnea and prioritizing health equity.
Aatif M. Husain, MD, Chief of Epilepsy, Sleep, and Clinical Neurophysiology at Duke University Hospital, commented, “TipTraQ represents a breakthrough in home-based sleep apnea testing. By integrating AI-driven analysis with a user-friendly wearable, this device can significantly improve early detection and treatment accessibility.”
About PranaQ
PranaQ is a digital healthcare company that develops wearable medical devices for sleep and breathing disorders. Its products feature AI-based biomedical signal-processing algorithms designed to monitor and analyze health conditions.
Founded in 2021 and based in New York City, PranaQ is dedicated to empowering individuals with better knowledge and control over their medical treatments by making diagnostics and monitoring more accessible, efficient, and patient-centered.
For more information on TipTraQ, contact us to learn more.
Media Contact:
Simon Kuo
Business Development Director
simon@pranaq.com