Biotricity receives US FDA 510(k) clearance for Bioflux software II system

Biotricity, a medical diagnostic and consumer healthcare technology company, announced that it has received a 510(k) clearance from the FDA for its Bioflux Software II System.

The software is engineered to improve workflows and reduce analysis time from 5 minutes to 30 seconds. ECG monitoring requires significant human oversight to review and interpret incoming patient data to discern actionable events for clinical intervention, highlighting the necessity of driving operational efficiency.

This improvement in analysis time reduces operational costs. This allows the company to continue to focus on exceptional customer service and industry leading response times to physicians and their at-risk patients. Additionally, these advances mean we can focus our resources on high-level operations and sales to help drive greater revenue.

“We are thrilled to receive this FDA clearance. The system further expands the diagnostic capabilities of our Bioflux device and positions Biotricity as a leader in the fast-growing remote patient monitoring market,” said Waqaas Al-Siddiq, CEO of Biotricity. “The increase in efficiency permits us to scale more quickly as we look forward to additional product launches for the upcoming year.”

The FDA clearance will continue to amplify Biotricity’s presence in the remote patient monitoring market, which is expected to reach US$ 1.8 billion by 2026.

Bioflux Software II System is available through Rx Only.