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The company's lead product, BresoDX1, has demonstrated strong clinical validation for at-home diagnosis of moderate to severe sleep apnea. In a pivotal study with 164 subjects comparing the device to in-lab polysomnography (PSG), sensitivity was 88.5% and specificity was 84.9% for detecting moderate-to-severe sleep apnea using established criteria. The product received FDA clearance in December 2022 and commercial launch began in the US market in Q3 2023.
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