PranaQ, an AI-driven sleep diagnostics company, has received US Food and Drug Administration (FDA) 510(k) clearance for TipTraQ, a home-based sleep apnea test.
The device, which employs biosensors and artificial intelligence (AI) algorithms, provides clinical-grade respiratory and sleep data while allowing patients to undergo testing at home.
With this regulatory clearance, PranaQ plans to introduce TipTraQ across the US, making it available to sleep clinics, telehealth providers, and hospitals.
PranaQ CEO Jerry Chen said: “Receiving FDA clearance for TipTraQ is a significant milestone in our mission to revolutionise sleep diagnostics and monitoring.
“With millions of undiagnosed sleep apnea sufferers, TipTraQ enables accessible and reliable at-home testing, helping more people receive timely diagnosis and treatment.”
PranaQ, backed by NAVER D2SF, is focused on developing AI-enabled medical devices for sleep and respiratory disorders. NAVER D2SF, the corporate venturing arm of NAVER, actively supports startups working on AI and healthcare technologies.
TipTraQ is designed as a single-point-of-contact wearable that detects sleep apnea events and analyses sleep patterns with high precision.
The compact device attaches to the user’s fingertip, capturing key health metrics, including pulse rate, blood oxygen saturation (SpO₂), blood pressure trends, respiration rate, and snoring patterns.
By integrating AI-driven biomedical signal processing, the wearable enables multi-night testing, providing a broader assessment of a patient’s sleep patterns without requiring a return visit to a clinic.
The device allows real-time data transmission via a secure cloud-based platform, eliminating the need for manual uploads or device returns. Healthcare providers can access longitudinal sleep data, enabling a more comprehensive evaluation of patients’ sleep health over time.
PranaQ has conducted clinical trials in North America and Asia, including studies at Duke University Hospital and the University of California, San Francisco (UCSF), to validate TipTraQ’s accuracy. The results demonstrated high sensitivity and specificity in detecting sleep apnea when compared to gold-standard polysomnography (PSG).
TipTraQ is also cleared for sleep apnea severity classification, identifying cases as mild (AHI ≥5), moderate (AHI ≥15), and severe (AHI ≥30) based on American Academy of Sleep Medicine (AASM) criteria 1a and 1b. This capability supports clinical decision-making by offering clear diagnostic thresholds.
TipTraQ is designed to provide consistent SpO₂ readings across all skin tones, addressing a recognised limitation in traditional pulse oximetry. By improving the accuracy of nocturnal oxygen saturation measurements, the device is intended to enhance diagnostic reliability, particularly in identifying sleep apnea-related oxygen desaturation events.
