biotricity Files for FDA 510(k)
REDWOOD CITY, Calif., July 12, 2016 (GLOBE NEWSWIRE) – biotricity inc. (BTCY), a medical diagnostic and consumer healthcare technology company dedicated to delivering innovative, biometric remote monitoring solutions, has filed for a 510(k) with the U.S. Food and Drug Administration (FDA).biotricity expects to receive a response from the FDA on its 510(k) submission by early Fall. Upon final release biotricity’s flagship product, the bioflux solution, will combine a proprietary mobile ECG monitoring device and an industry leading ECG viewer software package. The combination will enable physicians to remotely monitor and diagnose patients with cardiovascular disease and coronary heart disease by detecting arrhythmias, using an accredited 24 hour, 7 day per week, ECG monitoring facility.
biotricity founder and CEO Waqaas Al-Siddiq commented, “Submitting for a 510(k) is a very important milestone 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.”