SANSA HSAT

The SANSA HSAT is a Class II wearable medical device developed by Huxley Medical to aid in the evaluation of adult sleep-related breathing disorders in clinical and home settings. It leverages a combination of reflective PPG, single-lead ECG, and 3-axis accelerometer sensors, with data processed by a cloud-based algorithm and transmitted wirelessly, to provide biophysical parameters and summary metrics for diagnosis.

On January 28, 2025, a determination was issued regarding Huxley Medical's SANSA HSAT device, classified as a Class II breathing frequency monitor. This determination signifies that the device is substantially equivalent to legally marketed devices, thereby allowing Huxley Medical to market it. The SANSA HSAT is designed to record, analyze, and store biophysical parameters, aiding healthcare professionals in the evaluation of sleep-related breathing disorders in adults, and is intended for use in both clinical and home environments.The SANSA HSAT is a wearable device that collects physiological signals using a reflective PPG sensor, a single-lead ECG sensor, and a 3-axis accelerometer. These signals are processed via a cloud-based algorithm to produce various time-series channels and summary metrics for clinician review. A recent change to the device involved activating its cellular capability for wireless data transfer after a study, with USB transfer available as a secondary option. This modification was supported by comprehensive non-clinical testing, including software, cybersecurity, and wireless performance, confirming that it does not impact the device's core functionality, safety, or effectiveness. The manufacturer is expected to comply with ongoing regulatory requirements, including quality system regulations, labeling standards, and adverse event reporting.

AI Regulatory Concerns

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Jev reads the full FDA letter and returns calibrated concern probabilities per regulatory category. These are AI estimates, not regulatory advice.

• Q1. What specific biophysical parameters does the SANSA HSAT record and what are their clinical interpretations for sleep-related breathing disorders?; How does the cloud-based algorithm process the raw sensor data (PPG, ECG, accelerometer) to derive diagnostic metrics, and what is its validation against polysomnography?; What are the sensitivity and specificity of the SANSA HSAT in detecting various sleep-related breathing disorders compared to gold-standard diagnostic methods in both clinical and home settings?; What cybersecurity measures are in place to protect patient data transmitted wirelessly via the cellular capability, and has this been independently audited?; What are the long-term usability and adherence rates for patients using the SANSA HSAT in a home environment, and how does this compare to traditional diagnostic methods?