Dreamtech's Wireless ECG Patch 'Biosensor 1Ax' Receives US FDA Approval

Achievements Following Last Year's European CE Certification
Full-Scale Market Expansion into the US and Europe after India

Disposable wireless electrocardiogram patch 'Biosensor 1Ax' by Dreamtech. Photo by Dreamtech

[Asia Economy Reporter Heeyoon Kim] Dreamtech is making a full-scale entry into the US central and remote monitoring market based on wireless electrocardiogram (ECG) patches.

Dreamtech announced on the 22nd that its wireless ECG patch 'Biosensor 1Ax' and the 'remote monitoring platform' utilizing it received approval from the US Food and Drug Administration (FDA) on the 20th.

This approval follows the European CE certification obtained in May. According to Dreamtech, obtaining FDA approval has laid the foundation for entering the US and European markets, following its existing supply to the Indian market.

Dreamtech, together with its parent company Uniquest, has invested in the US healthcare specialist company LifeSignals to jointly develop the biosensor. In 2018, 'Biosensor 1A' received FDA approval for hospital use (central monitoring) and has been supplied to the US, Europe, India, and other regions. In July last year, it additionally obtained FDA approval for remote monitoring use.

The newly approved 'Biosensor 1Ax' is an enhanced version of the existing 'Biosensor 1A' with added functions such as body temperature and respiration measurement. When attached to the patient's chest area, key vital signs including ECG, heart rate, body temperature, and respiration rate are transmitted to the cloud. It is characterized by real-time monitoring capability not only on electronic devices such as smartphones and tablet PCs but also on patient monitors and hospital central monitoring systems.

Notably, the approval also includes the 'remote monitoring platform' that can monitor the vital signs of patients wearing the patch. It is designed to be highly interoperable with the patch and capable of monitoring a large number of patients simultaneously. It allows real-time checking of patients' vital signs in hospitals and homes without restrictions on time and place.

Dreamtech is accelerating its healthcare business utilizing the biosensor. The next-generation model 'Biosensor 2A,' which adds oxygen saturation (SpO2) measurement functionality to the 'Biosensor 1Ax,' is nearing completion. Dreamtech added that the ultimate goal is to add functions such as blood pressure measurement to remotely monitor the vital signs of all patients within hospitals.

Max Daeyoung, Head of Dreamtech's Convergence Business Division, said, "This FDA approval is significant because it includes not only the wireless ECG patch but also the platform that can remotely monitor patients' vital signs in hospitals and homes in real time." He added, "Based on our capabilities in developing smart medical devices and manufacturing know-how, we will diversify our business models and strive to contribute to domestic and international medical environments characterized by non-face-to-face healthcare."

This content was produced with the assistance of AI translation services.