On Feb. 18, 2025, PranaQ announced it received FDA 510(k) clearance for TipTraQ, a compact home sleep apnea test (HSAT) wearable that uses advanced biosensors and AI algorithms to detect sleep apnea events and analyze sleep architecture with clinical-grade accuracy.
About TipTraQ
TipTraQ is a wearable device placed on the tip of the finger. A compact HSAT, TipTraQ uses leverages advanced biosensors and AI algorithms to identify sleep apnea events and assess sleep architecture with clinical-grade precision.
Users download an app, answer questions about sleep habits, pair the device with a smartphone, and attach it to the finger before recording. Overnight, the device uploads sleep data to the app, which is analyzed by an AI algorithm to generate a report. Users can then schedule a consultation with a sleep specialist based on the results.
The device measures pulse rate, SpO2 and blood pressure trends, analyses snoring and respiration rate, and provides insights on sleep quality trends. It records two signals: tri-wavelength photoplethysmography (PPG) for oxygen saturation, respiratory effort and pulse rate, and 3-axis gyroscopes and accelerometers to capture motion-based activity for total sleep and REM time. TipTraQ is cleared for detecting sleep apnea severity with cutoff thresholds of 5 (mild), 15 (moderate) and 30 (severe).
The device comes with a charging case and supports remote data transfer, allowing for multi-night testing and continuous treatment monitoring, providing health care professionals with a longitudinal view of patients’ sleep at home. TipTraQ has been validated in clinical trials at Duke University Hospital and the University of California San Francisco, showing high sensitivity and specificity when compared to polysomnography.
According to the company’s press release, PranaQ plans to launch the device nationwide, making TipTraQ available to sleep clinics, telehealth providers and hospitals.
About HSATs
HSATs are portable devices designed to monitor and record key physiological parameters such as airflow, oxygen levels and breathing patterns during sleep. These convenient diagnostic tools offer an alternative to traditional in-lab sleep studies, providing a more accessible and comfortable option for detecting sleep apnea in the convenience of one’s own home.
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