Summary: The FDA has granted 510(k) clearance to TipTraQ, a wearable home sleep apnea test by PranaQ that uses AI-driven biosensors to detect apnea events, enabling remote, multinight testing and aiming to improve early diagnosis and treatment accessibility.
Key Takeaways:
- The device is a user-friendly wearable that uses a single point of contact for sleep apnea detection.
- TipTraQ utilizes biosensors and artificial intelligence to detect sleep apnea events and analyze sleep architecture.
- The device supports remote data transfer, eliminating the need for patients to return it and allowing continuous monitoring.
The US Food and Drug Administration (FDA) has granted 510(k) clearance to TipTraQ, a home sleep apnea test with a single point of contact by a digital healthcare company called PranaQ.
“Receiving FDA clearance for TipTraQ is a significant milestone in our mission to revolutionize sleep diagnostics and monitoring,” says Jerry Chen, CEO of PranaQ, which was founded in 2021, in a release. “With millions of undiagnosed sleep apnea sufferers, TipTraQ enables accessible and reliable at-home testing, helping more people receive timely diagnosis and treatment.”
TipTraQ is a wearable that uses biosensors and artificial intelligence (AI) algorithms to detect sleep apnea events and analyze sleep architecture. It supports remote data transfer, so patients don’t need to return the device after each night, facilitating multinight testing and continuous treatment monitoring. It includes a charging case.
TipTraQ is cleared for its ability to identify sleep apnea severity cutoffs of 5 (mild), 15 (moderate), and 30 (severe) under both the American Academy of Sleep Medicine 1A and 1B rules.
TipTraQ’s accuracy is backed by multiple clinical trials across North America and Asia, including trials conducted by Duke University Hospital and the University of California, San Francisco.
Aatif M. Husain, MD, chief of epilepsy, sleep, and clinical neurophysiology at Duke University Hospital, says in a release, “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.”
PranaQ now plans to launch TipTraQ nationwide, making it available to sleep clinics, telehealth providers, and hospitals.
