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Consumers want to measure their personal health. As a result, wearables are becoming a huge business. According to the Consumer Technology Association, 20 percent of U.S. households currently own wearable fitness trackers; a number that doubled from last year and is expected to grow by 15 percent next year.[1] We are in a world of wearable technology, getting more crowded by the minute with companies rolling out products that promise to measure vitals such as blood pressure, body temperature and even behavioral changes.

Does the Device Provide Medically Relevant Data or Just Fitness Stats?

It’s one thing to measure how many steps someone takes in a day to help with fitness goals. It’s quite another to help prevent and manage chronic illnesses. So as the plethora of devices hits the mainstream, it’s important for consumers and healthcare providers alike to understand the differences, what is still needed and what’s yet to be developed.

Wearables fill the medical diagnostic – as well as – the consumer health and fitness space. Waters get muddy when products that are consumer-grade are positioned as medically relevant and marketed as such. An important question to ask and answer is: Are these devices capturing and delivering data that is clinical-grade and can this data help to manage chronic illnesses? It’s important for consumers to understand the difference between a device that tells them how many steps they walked, versus a device that can remotely monitor their heart arrhythmias and transmit that information in real-time to their physicians.

Consumer versus Patient Focus

FitBit has had tremendous success in the consumer fitness market and is considered one of the giants in wearable tech. FitBit provides wearables that measure steps walked, distance traveled and calories burned, for example. FitBit’s products can be purchased directly by consumers interested in their fitness and activity.

People concerned about preventing or managing chronic illnesses need wearable devices that differ from FitBit’s products because FitBit was not designed to be a medical grade device that can be used to prevent or manage chronic illnesses. Biotricity is a player in the medical space that is innovating within the remote patient monitoring segment to help chronically ill patients. Biotricity offers wearable solutions that provide real-time data for ailments such as heart arrhythmias to prevent and manage chronic disease. Because Bioflux is an actual medical device, it needs to be prescribed by a physician and cannot be purchased over the counter. Basically, Biotricity’s flagship product, Bioflux, will be used in the healthcare market for chronic illnesses — much like a FitBit is used as a fitness tracker in the consumer market.

FDA Cardiovascular Device Classification System



The Food and Drug Administration (FDA) has a tri-level classification system for medical devices. The categories are determined by the harm to the consumer if something goes wrong with the device. A device in Class I would cause the least amount of harm and a device in Class III would cause the most. Medical devices such as Biotricity’s Bioflux, which measures arrhythmias, are categorized as Class II.

As more companies enter the medical monitoring space it is vitally important for physicians and consumers alike to understand what they are monitoring, and the gravity of the situation. To be relevant in the medical space, data must be clinical-grade. To provide the best outcomes, transmission of this data needs to be in real-time. Pulling the two together will be key, as we strive to increase the quality of care, improve outcomes and lower patient risk.