Biotricity Submitted 510(k) U.S. FDA Filing for Biotres

Biotres is a compact and discreet 3 channel Holter solution

Biotricity Inc., a medical diagnostic and consumer healthcare technology company, announced that it made a 510(k) submission to the U.S. Food and Drug Administration (FDA), on December 31, 2020, for Biotres. The company expects this process to take at least 4 months, and if the Company’s 510(k) application is cleared by the FDA, the Company expects a product launch thereafter.

As announced previously, Biotres is a 3-lead patch product for ECG and arrhythmia monitoring for patients at risk for or being diagnosed with certain cardiac issues. Biotres can work as a Holter, Event Loop, and Extended Holter.

“We are excited to announce the 510(k) FDA submission for Biotres and look forward to building out our product offerings further in 2021,” stated Waqaas Al Siddiq, CEO of Biotricity. “We believe that Biotres addresses demand from some of our existing customers and a need in the Holter market.”

The Biotres is a Holter product that was developed to address the challenges that exist with current Holter patch products. The Biotres is designed with the following key features:

• 3 Channel Recording – A wearable Holter patch device that can provide continuous 3 channel recording of ECG (heart) data. All other Holter patch devices are 1 channel or 2 channels.
• Rechargeable Battery – The device can be worn continuously for 48 hours, before needing to be charged for 1 hour, enabling continuous data collection for extended periods of time without any intervention, something not possible with traditional Holter patch solutions.
• Wireless Connectivity – The unique device utilizes Bluetooth technology to offload data, reducing the time for diagnoses. Current Holter patch solutions can take up to a week before diagnoses are available due to manual data downloading and a lack of connectivity.
• User-Friendly Design – Easy to understand and comfortable to wear during regular day-to-day activities.

About Biotricity Inc.

Biotricity is reforming the healthcare market by bridging the gap in remote monitoring and chronic care management. Doctors and patients trust Biotricity’s unparalleled standard for preventive & personal care, including diagnostic and post-diagnostic solutions for chronic conditions. The company develops comprehensive remote health monitoring solutions for the medical and consumer markets. To learn more, visit www.biotricity.com.