Healthcare Industry News: cardiac monitor
News Release - April 12, 2017
Biotricity Files for its Second and Final FDA 510(k) to Bring Bioflux Solution to MarketREDWOOD CITY, Calif., April 12, 2017 -- (Healthcare Sales & Marketing Network) -- Biotricity, Inc. (OTCQB:BTCY), a medical diagnostic and consumer healthcare technology company dedicated to delivering innovative, biometric remote monitoring solutions, has filed for a second and final 510(k) for the hardware portion of its Bioflux solution with the U.S. Food and Drug Administration (FDA). Biotricity expects to receive a response from the FDA on its 510(k) submission by summer 2017. Biotricity has already received FDA approval for the software portion of its remote cardiac monitoring wearable.
This 510(k) is the final regulatory requirement needed for Biotricity to bring its Bioflux solution to the multi-billion dollar cardiac monitoring market. Biotricity’s flagship product, the Bioflux solution, combines a proprietary mobile ECG monitoring device and an ECG viewer software package. Together with an accredited 24 hour, 7 day per week, ECG monitoring facility, Bioflux enables physicians to remotely monitor and diagnose patients with cardiovascular disease and coronary heart disease by detecting arrhythmias.
Biotricity founder and CEO Waqaas Al-Siddiq commented, "The company is incredibly excited about reaching this key milestone. Submitting a 510(k) for our hardware is a very important step for the company as we prepare to commercialize our first medical solution. We believe significant opportunity exists for our remote patient monitoring solutions to gain traction in the rapidly expanding diagnostic and preventative healthcare markets.”
About Biotricity Inc.
Biotricity is a modern medical technology company focused on delivering innovative, remote biometric monitoring solutions to the medical and consumer markets, including diagnostic and post-diagnostic solutions for chronic conditions and lifestyle improvement. Biotricity’s R&D continues to focus on the preventative healthcare market, with a vision of putting health management into the hands of the individual. The company aims to support the self-management of critical and chronic conditions with the use of innovative solutions to ease the growing burden on the healthcare system. To learn more, visit www.biotricity.com.
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