FDA Grants New Device for At-Home Sleep Apnea Testing 510(k) Clearance

The US Food and Drug Administration (FDA) has granted 510(k) to the BresoDX1 device for at-home sleep apnea testing manufactured by Bresotec Medical. A 510(k) is a premarket submission made to the FDA to show that the device intended to be marketed in the future is safe and effective.

“Through the collection of tracheal breath sounds and motion, Bresotec’s proprietary technology utilizes respiratory airflow as its primary means of measurement,” said Bresotec founder and chief medical officer, Dr Douglas Bradley, MD, FRCP, FCAHS. “This unique approach, coupled with strong clinical validation, leaves BresoDX1 uniquely positioned to address the growing, but under-served opportunity in at-home sleep apnea diagnosis.”

In the United States, nearly 80% of those suffering from sleep apnea go without diagnosis or treatment due to the financial and accessibility challenges posed by an overnight stay in a sleep lab for evaluation.

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To use the BresoDX1 device, patients wear a sensor on the neck positioned over the trachea and a pulse oximeter sensor on their finger. Together, these 2 inputs record an individual’s tracheal breathing sounds and movements, neck and body position, oxygen saturation (SpO2), and heart rate during sleep.

Throughout the test, the data collected are transmitted, processed, and stored wirelessly within a small hub, which then uploads the information to the cloud to be analyzed by the BresoDX1 software. The device ultimately generates a thorough sleep report comprising airflow, respiratory movements, frequency of apneas and hypopneas, dips in SpO2, body position, and heart rate throughout the night.

“Over the past several years, the market has experienced a significant shift from in-lab PSG testing to at-home testing,” said Peter Bloch, chief executive officer of Bresotec Medical. “While legacy at-home tests have lowered barriers for patient use, few offer the reliability, ease-of-use, and accuracy of BresoDX1.”

Reference

Bresotec’s BresoDX1 for at-home sleep apnea testing receives FDA 510(k) clearance. News release. Businesswire. January 3, 2022. Accessed February 23, 2022.