biotricity Receives FDA 510(k) Clearance for Key Component of its Wearable Solution

biotricity inc., a healthcare technology company dedicated to delivering medically relevant biometric remote monitoring solutions, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for a key component of its solution. The clearance is touted by the firm as a watershed moment in the company’s quest to market its remote cardiac monitoring solution comprised of the bioflux software and device. By developing medical remote monitoring solutions that help diagnose and manage chronic diseases, biotricity seeks to revolutionize the health industry by bridging the gap in chronic care management.
 
“Achieving an FDA clearance validates the capability of biotricity to meet its vision of developing a series of clinically accurate medical devices that are applicable in both medical and home-based settings,” said Waqaas Al-Siddiq, founder and CEO of biotricity. “Receiving a 510(k) clearance is a significant accomplishment towards our goal of enabling physicians to remotely monitor and diagnose patients with cardiovascular disease and coronary heart disease. More importantly, it is yet another step to making this vision a reality.”
 
biotricity’s mission is to develop multiple solutions for a variety of chronic illnesses by designing monitoring devices paired with chronic care management tools. Upon commercial availability, the device will be used by physicians and hospitals in the diagnostic process and then by patients for long-term care management. This is particularly important because traditional healthcare diagnostic solutions are generally restricted to the physician’s office or inside of the hospital. biotricity’s focus is to develop solutions that improve patient compliance, and empowers the individual to take better care of their health in order to facilitate chronic disease management for long-term care. 
 
“While wrist-worn fitness devices are incredibly popular and valuable for the fitness and lifestyle markets, they are not applicable for chronic patients. The reality is they are not cleared by the FDA, and we believe some of them may not be capable of reliably measuring heart rates,” said Al-Siddiq. “Unlike these light weight lifestyle/fitness devices, we aim to impact the healthcare by targeting at-risk patients and to do that you need medically relevant devices.”
 
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 has offices in Redwood City, Calif., and Toronto, Canada.