Biotricity Inc. Submits 510(K) U.S. FDA Filing for Biotres
January 05, 2021 at 08:00 am EST
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Biotricity Inc. 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. 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 hr., 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.
Biotricity Inc. is a medical technology company focused on biometric data monitoring and diagnostic solutions. The Company developed its Bioflux technology, comprised of a monitoring device and software components. The Bioflux device is comprised of a wet electrode worn on a belt clip around the waist. The Bioflux ECG reporting software enables doctors and labs to view a patientâs electrocardiogram (ECG) data for monitoring and diagnostic purposes. Its Bioflux platform has a built-in cellular chipset and a real-time embedded operating system, which allows for its technology to be utilized as an Internet of Things (IoT) platform. It has developed several technologies, including Biotres, Bioheart, and Biocare. Biotres is an ECG Holter solution that addresses the limitations of existing solutions in the Holter market. Bioheart is a personal cardiac monitoring solution for consumers. Biocare is a cardiac disease management platform for chronic care management and remote patient monitoring.