Bioflux device achieves FDA 510(k) clearance
Biotricity Inc. has received its 510(k) clearance for its Bioflux device with the FDA. This latest 510(k) is the final FDA requirement needed for Biotricity to bring to market Bioflux in the US. Bioflux consists of a proprietary mobile ECG monitoring device and an ECG viewer software package, that enables physicians to remotely monitor and diagnose patients with cardiovascular coronary heart disease by detecting and transmitting probable arrhythmias, along with other diagnostic heart information.
The remote monitoring solution can be utilised for early detection and we believe is an example of the growing shift in healthcare towards a preventative system.
Biotricity has started its first production run of the Bioflux solution. With large scale manufacturing already in place, the company is primed to begin mass production. “We are ready to hit the ground running,” said Waqaas Al-Siddiq, Founder and CEO of Biotricity. “With our manufacturing infrastructure fully developed, we expect to be able to bring the Bioflux solution to market imminently.”
“We are incredibly excited about receiving our hardware 510(k) clearance as this is the final step needed before commercialising our first medical-grade solution,” said Al-Siddiq.
“As we bring Bioflux to market, we intend to continue to develop other disease specific remote biometric technologies that can help diagnose, treat, and manage chronic diseases through clinically accurate and tailor-made solutions.”
The company’s proprietary remote patient monitoring platform can be leveraged for other industries and plans are already underway to pipeline new solutions across a spectrum of health applications. The company looks forward to executing its ongoing product development plans and bringing to market other innovative remote medical technologies.
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