On Feb. 5, 2025, Huxley Medical introduced that the FDA has cleared the SANSA residence sleep apnea take a look at to make use of mobile information add, eliminating the necessity for Bluetooth pairing or apps, lowering failed residence testing and simplifying the diagnostic course of.
About SANSA
SANSA is a chest-worn diagnostic patch designed to assist within the analysis of sleep-related respiration issues in adults suspected of obstructive sleep apnea (OSA). Cleared by the FDA in July 2024, it incorporates a single-point pores and skin contact design, eliminating the necessity for further attachments, wires, belts or hoses.
The machine integrates a reflective photoplethysmography (PPG) sensor, a single-lead electrocardiogram (ECG) sensor and a 3-axis accelerometer to measure key physiological alerts reminiscent of blood oxygen saturation, coronary heart price, respiratory effort, loud night breathing and sleep staging. It’s supposed to be worn for 10 hours per research.
Validated in a 340-patient scientific trial evaluating it to gold-standard polysomnography, SANSA demonstrated efficacy in measurement reliability and efficiency to be used in diagnosing delicate, reasonable and extreme OSA.
This newest FDA clearance allows SANSA to transmit take a look at information through mobile add, permitting physicians to obtain outcomes with out requiring affected person interplay with a smartphone or Bluetooth pairing.
In keeping with the corporate’s press launch, SANSA is the one hands-free, wire-free and app-free take a look at answer. SANSA is meant to be used in adults aged 22 years and older and is out there by prescription solely.
About OSA
OSA is a prevalent and critical sleep problem the place the airway turns into repeatedly blocked throughout sleep, resulting in paused respiration and oxygen deprivation. Generally attributable to the collapse of throat tissues, it may end up in loud loud night breathing, choking noises and frequent awakenings, doubtlessly contributing to well being points reminiscent of hypertension, coronary heart illness, stroke, diabetes and despair.
Learn extra trade information from the AASM.
Photograph: Web_SANSA
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