On July 31, 2024, Huxley Medical announced it received FDA 510(k) clearance for its chest-worn sleep apnea diagnostic patch, SANSA.
About SANSA
SANSA is a wearable device intended for use in recording, analysis and storage of biophysical parameters to aid in the evaluation of sleep-related breathing disorders in adults suspected of obstructive sleep apnea (OSA). It is a single-point-of-skin-contact diagnostic device that does not require additional attachments, wires, belts or hoses.
The SANSA device contains a photoplethysmography (PPG) sensor, an electrocardiogram (ECG) sensor and an accelerometer. Its sensors measure several physiological signals, including blood oxygen saturation, ECG-derived heart rate, chest movement, snoring, body position, sleep staging, respiratory effort and actigraphy. The device is intended to be worn for 10 hours per study.
According to the company’s press release, SANSA is the “first and only FDA-cleared chest-worn patch that utilizes advanced signal processing and artificial intelligence to detect sleep disordered breathing while simultaneously providing an electrocardiogram reference channel to record electrical signals from the heart.”
In a multi-center clinical study involving 533 patients, SANSA demonstrated efficacy in measurement reliability and performance for use in diagnosing mild, moderate and severe OSA.
SANSA is intended for clinical or home use.
About OSA
OSA is a serious sleep disorder where the airway becomes repeatedly blocked during sleep, causing pauses in breathing. This condition, often marked by loud snoring and choking noises, can lead to oxygen deprivation, disrupting sleep and contributing to various health issues such as high blood pressure, heart disease, stroke and diabetes.
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