Bresotec Earns FDA Nod for BresoDX1 Home Sleep Apnea Testing

Bresotec Medical, a company that makes non-invasive portable diagnostic devices for accurate, at-home sleep apnea diagnosis, has gained U.S. Food and Drug Administration (FDA) 510(k) clearance for BresoDX1, its first product for at-home sleep apnea testing.
 
BresoDX1 aids in diagnosis of moderate to severe sleep apnea in adults in the at-home setting. It has only two diagnostic inputs and records physiological signals during sleep, scores apneas and hynopneas, and can be administered without clinical assistance.
 
Once data is uploaded to the software, BresoDX1 can be a reliable, turnkey diagnostic tool with transparent reporting.
 
“Over the past several years, the market has experienced a significant shift from in-lab PSG [polysomnography] testing to at-home testing,” Peter Bloch, CEO of Bresotec Medical told the press. “While legacy at-home tests have lowered barriers for patient use, few offer the reliability, ease-of-use, and accuracy of BresoDX1.”
 
Patients place a sensor on the neck over the trachea and wear a pulse oximeter sensor on the finger. These inputs record tracheal breathing sounds and movements, neck and body position, oxygen saturation, and heart rate during sleep. During the test, data is wirelessly sent to a small hub for preprocessing and storing, then uploaded to the cloud where they are analyzed by the BresoDX1 software.
 
The software generates a comprehensive sleep report showing airflow, respiratory movements, frequency of apneas and hypnopneas, and dips in SpO₂, body position, and heart rate.
 
The company plans to begin a limited launch in the beginning of 2023, with full commercial launch expected in the third quarter.