On Feb. 5, 2025, Huxley Medical announced that the FDA has cleared the SANSA home sleep apnea test to use cellular data upload, eliminating the need for Bluetooth pairing or apps, reducing failed home testing and simplifying the diagnostic process.
About SANSA
SANSA is a chest-worn diagnostic patch designed to aid in the evaluation of sleep-related breathing disorders in adults suspected of obstructive sleep apnea (OSA). Cleared by the FDA in July 2024, it features a single-point skin contact design, eliminating the need for extra attachments, wires, belts or hoses.
The device integrates a reflective photoplethysmography (PPG) sensor, a single-lead electrocardiogram (ECG) sensor and a 3-axis accelerometer to measure key physiological signals such as blood oxygen saturation, heart rate, respiratory effort, snoring and sleep staging. It is intended to be worn for 10 hours per study.
Validated in a 340-patient clinical trial comparing it to gold-standard polysomnography, SANSA demonstrated efficacy in measurement reliability and performance for use in diagnosing mild, moderate and severe OSA.
This latest FDA clearance enables SANSA to transmit test data via cellular upload, allowing physicians to receive results without requiring patient interaction with a smartphone or Bluetooth pairing.
According to the company’s press release, SANSA is the only hands-free, wire-free and app-free test solution. SANSA is intended for use in adults aged 22 years and older and is available by prescription only.
About OSA
OSA is a prevalent and serious sleep disorder where the airway becomes repeatedly blocked during sleep, leading to paused breathing and oxygen deprivation. Commonly caused by the collapse of throat tissues, it can result in loud snoring, choking noises and frequent awakenings, potentially contributing to health issues such as high blood pressure, heart disease, stroke, diabetes and depression.
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Photo: Web_SANSA
