Huxley Medical has received the US Food and Drug Administration (FDA) 510(k) clearance for its SANSA sleep apnoea diagnostic patch.
The chest-worn device is designed to simplify the diagnosis of sleep apnoea, a condition that can lead to severe health complications.
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This patch, which is claimed to be a first-of-its-kind at-home diagnostic device, requires no additional attachments, belts, wires or hoses.
It utilises a patented combination of sensors to measure eight physiological channels, enhancing the ease and accuracy of sleep apnoea diagnosis.
The channels include electrocardiogram (EKG)-derived heart rate, blood oxygen saturation, chest movement, respiratory effort, sleep staging, body position, snoring and actigraphy.
This clearance marks a pivotal moment for Huxley Medical, positioning the SANSA device as the only FDA-cleared chest-worn patch that employs advanced signal processing and AI.
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By GlobalDataFurthermore, the company can now proceed to market the device.
Huxley Medical co-founder and chief commercial officer Chris Hallett said: “Our SANSA technology offers healthcare providers a cutting-edge tool to enhance diagnostic accuracy and patient outcomes.”
The technology is designed to detect sleep-disordered breathing and provide an EKG reference channel.
It was evaluated in a clinical trial involving 533 patients across seven sites in the US, which demonstrated the device’s reliability and performance in diagnosing varying degrees of sleep apnoea.
The University of Michigan, University of Pennsylvania, Emory University and Atrium Health Wake Forest Baptist were among the sites that participated in the study.
The trial’s data underscored SANSA’s safety and effectiveness, highlighting its high accuracy and patient compliance.
SANSA’s non-invasive nature was shown to improve patient comfort, a critical factor in compliance and successful diagnosis.
Since its inception in 2019, Huxley Medical has raised investment capital and grant funding of more than $20m.
