REDWOOD CITY, Calif., Nov. 15, 2017 (GLOBE NEWSWIRE) — Biotricity Inc. (OTCQB:BTCY), a medical diagnostic and consumer healthcare technology company dedicated to delivering innovative, biometric remote monitoring solutions, is pleased to announce that it has filed its response to the FDA with the additional information requested. The company expects to receive further communication from the FDA within 30 days.
A 510(k) is a premarket submission made to the FDA to demonstrate that the device to be marketed is as safe and effective, at the very least, as a legally marketed device. It is an interactive process with reviewers who use manufacturer evidence to assess the substantial equivalence of the new device. The reviewers rely on FDA guidance documents and recognized safety standards to determine the equivalence of this device to devices that have previously been commercialized.
Biotricity is pleased that it was able to collect all the information requested and submit its response in a timely manner. The company is confident in its FDA process and believes it is well positioned to achieve its target timetable.
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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