Biotricity inc has received a 510(k) clearance from the U.S. Food and Drug Administration (FDA) for a key component of its solution. This clearance is another 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 prevent and manage chronic diseases, biotricity seeks to revolutionize the health industry by bridging the gap in chronic care management.
Waqaas Al-Siddiq, Founder and CEO of biotricity said, “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. 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.
In an address at the American Medical Association’s (AMA) annual meeting, CEO James Madara, MD, discussed the great advances in wearable technology as “remarkable tools.” But his thoughts on consumer wearables were harsh. “Appearing in disguise among these positive products are other digital so-called advancements that don’t have an appropriate evidence base (unregulated), or just don’t work well. They confuse patients, impede care, and waste our (physicians’) time.” He went on to call unregulated wearables “digital snake oil” and “quackery.”
