Canada-based Bresotec Medical announced that its BresoDX1 device has secured 510(k) clearance from the US Food and Drug Administration (FDA) for at-home sleep apnea testing.
According to Bresotec Medical, BresoDX1 is to be used in the US for the diagnosis of moderate to severe sleep apnea in adults in an at-home setting.
Using two diagnostic inputs, the device monitors the physiological signals of patients while they sleep. The device also scores apneas and hypopneas, and can be used by the patient in a home environment without clinical help.
BresoDX1 provides clinicians with a turnkey diagnostic instrument with completely transparent reporting after data is uploaded to the device’s software, claimed Bresotec Medical.
The FDA submission for the device was filed on the basis of clinical trials on a total of 164 patients.
Bresotec Medical CEO Peter Bloch said: “Over the past several years, the market has experienced a significant shift from in-lab PSG testing to at-home testing.
“While legacy at-home tests have lowered barriers for patient use, few offer the reliability, ease-of-use, and accuracy of BresoDX1.”
With BresoDX1, patients wear a pulse oximeter sensor on the finger and a sensor on the neck over the trachea.
Together, these inputs capture the patient’s heart rate, oxygen saturation (SpO2), neck and body posture, tracheal breathing noises and motions, and breathing patterns while they are sleeping, the medical device firm said.
Bresotec Medical said that the test wirelessly sends the data to a small hub for pre-processing and storage. The BresoDX1 software analyses the data when it is transferred from the hub to the cloud.
This analysis results in a sleep report that includes airflow, respiratory movements, the frequency of both apneas and hypopneas, drop in SpO2, body position, and heart rate.
Physicians can evaluate, understand, and can modify automated scoring based on the sleep reports.
The Canadian firm intends to start a limited, controlled launch of the device in Q1 2023, followed by a full commercial launch in the third quarter.
