FDA approval and clearance can take time, due to the multiple stages involved. We wrote about Biotricity‘s Bioflux wearable ECG system in the past when one of its components was cleared by the FDA in 2016. Late in 2017, Biotricty announced it had passed the final step for FDA clearance for the BioFlux device.
Bioflux is a real-time three-lead mobile cardiac telemetry (MCT) system. Rather than take a one-time reading of the electrical impulses that are indicators of heart health, Bioflux continuously monitors and transmits the impulse readings data to the cloud in real time. System software analyzes both the device and the data to support emergency response and to aid physician diagnosis. With up to 30 days of collected data from the three Bioflux leads, physicians can make their determinations based on a wealth of beat and rhythm data rather than react to a single or just a few readings. The sampling rate can be adjusted remotely to up to 1,000 times a second for increased clinical precision.
Continuous monitoring with Bioflux moves the needle in the direction of prevention, not just detection and reaction. Biotricity has already begun the first production run and is gearing up for mass production to bring the Bioflux system to market quickly.