The Food and Drug Administration (FDA) has granted 510(k) clearance to BresoDX1 to aid in the diagnosis of moderate to severe sleep apnea in an at-home setting.
BresoDX1 is designed to record a patient’s physiological signals during sleep using a sensor and a pulse oximeter. The sensor is placed on the neck over the trachea and the pulse oximeter is placed on the finger. These 2 diagnostic inputs record the patient’s tracheal breathing sounds and movements, neck and body position, oxygen saturation, and heart rate during sleep.
The collected data is transmitted wirelessly for preprocessing and storing, then uploaded to the cloud where it is analyzed by the BresoDX1 software. The software generates a report that captures several data points including airflow, respiratory movements, frequency of apneas and hypopneas, dips in SpO2, body position, and heart rate.
“Over the past several years, the market has experienced a significant shift from in-lab PSG testing to at-home testing,” said Peter Bloch, CEO 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.”
The Company expects to initiate a controlled, limited launch in the first quarter of 2023 with a full commercial launch in the third quarter of 2023.
Bresotec’s BresoDX1 for at-home sleep apnea testing receives FDA 510(k) clearance. News release. Bresotec Medical. Accessed January 3, 2023. https://www.businesswire.com/news/home/20230103005755/en/Bresotec%E2%80%99s-BresoDX1-for-At-Home-Sleep-Apnea-Testing-Receives-FDA-510-k-Clearance.