PranaQ's AI Sleep Apnea Test Gains FDA Clearance

PranaQ, supported by NAVER D2SF, has received FDA 510(k) clearance for its AI-enabled home sleep apnea test, TipTraQ, announced in a press release. This clearance allows PranaQ to launch TipTraQ nationwide, making it available to sleep clinics, telehealth providers, and hospitals across the U.S.

TipTraQ is a compact wearable device that uses advanced biosensors and AI algorithms to detect sleep apnea events and analyze sleep architecture with clinical-grade accuracy. The device is designed for home use, enabling patients to undergo testing without the need for hospital visits, thus reducing barriers to diagnosis and improving patient compliance.

The wearable includes a charging case and supports remote data transfer, allowing for seamless multi-night testing and continuous treatment monitoring. TipTraQ's accuracy has been validated through clinical trials in North America and Asia, demonstrating high sensitivity and specificity compared to traditional polysomnography.

PranaQ's CEO, Jerry Chen, highlighted the significance of this milestone, emphasizing the device's potential to provide accessible and reliable at-home testing for millions of undiagnosed sleep apnea sufferers.