FDA Grants Clearance to Biotricity’s Arrhythmia Monitoring Device

FDA recently granted 510(k) clearance to Biotricity’s Biotres Cardiac Monitoring Device for ECG and arrhythmia monitoring.

Biotres Cardiac Monitoring Device offers a wearable Holter patch device to provide continuous three-channel recording of ECG data. Currently, all other known Holter patch devices are one or two channels.

The device’s Bluetooth technology helps to offload data, reducing time to diagnosis. And the rechargeable battery can be worn for 48 hours before needing to be charged, allowing researchers to collect continuous data for extended periods without intervention.

Overall, the Biotres Cardiac Monitoring Device design addresses the current limitation of existing Holter monitors, provides flexibility to support future features, and creates a revenue stream with a simplified workflow to lower overall turnaround time and risk for patients and providers.

“We are extremely proud of this accomplishment and its potential to reshape the future of cardiac prevention and monitoring with this novel platform,” Waqaas Al-Siddiq, CEO and founder of Biotricity, said in the announcement.

“We now have another option for providing a secondary product for doctors and hospitals to meet their patients’ cardiac monitoring needs. Coupled with the recent successful non-dilutive financing, we believe we are well capitalized to execute the expansion of our commercialization efforts,” Al-Siddiq continued.

The Biotres Cardiac Monitoring Device expands Biotricity’s public portfolio and opens up a new market to increase its total addressable market from $1 billion to $5.7 billion.

The device will be widely available in April 2022.

Heart disease is the leading cause of death for both men and women in the US. Specifically, about 659,000 people die from heart disease annually.

Additionally, the disease costs the US nearly $363 billion each year, including the cost of healthcare services, medicines, and lost productivity.

Al-Siddiq emphasized that heart disease remains a chronic issue requiring persistent intervention, monitoring, and management. But the Biotres device may be a critical tool to improve patient lives and reduce overall costs.