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Are Medical Grade Devices The Next Generation Of Wearables?

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Fitbit Inc. has a market cap of $3.67 billion and leads the consumer wearable fitness monitoring industry. In addition to the Garmin Forerunner 235, TomTom Spark and Polar M400, there are a number of wearables that measure your heart-rate and map that to your fitness level. But these consumer devices are not medical devices and are not tied to a medically healthy heart.

Wearable technology continues to grow. According to the International Data Corporation (IDC) Worldwide Quarterly Wearable Device Tracker, wearable device shipments will reach 173.4 million units in 2019

At the same time, according to the Centers for Disease Control Foundation, cardiovascular disease related costs will cost the US healthcare system 1.1 trillion by 2030. 

Philips is looking at this market with their own approach. Earlier this year in 2016, they introduced a medical-grade, wearable biosensor that automatically and continuously measures heart rate, respiratory rate, skin temperature, single-lead ECG, posture and activity data for at-risk patients in low acuity settings in hospitals. The company's new biosensor-enabled solution is positioned to help caregivers detect early signs of patient deterioration and intervene earlier.

Newcomer, Biotricity provides medical remote monitoring solutions to physicians via their new device called Bioflux. Bioflux is an electrocardiogram (ECG) monitor, software and a monitoring lab, targeting cardiovascular disease through diagnostic and post-diagnostic care processes. The company says Bioflux allows mobile remote viewing of human heart beat and instantly transmits heart data to patients and their doctors.

A 650-bed hospital in Alberta, Canada, Rockyview General Hospital, is currently doing a four month study with Biotricity to determine the effectiveness of monitoring heart rate variability (HRV) to predict the onset of illness in intensive care unit patients.

“The challenges and evolution for wearables will be focused on regulatory hurdles, compliance, and reimbursement. In order to achieve insurance reimbursement from the clinical side, wearables will need to be validated for medical relevance and benchmarked against existing clinical solutions will require FDA clearances and essentially turn wearable firms into medtech firms," said Waqaas Al-Siddiq, Co-founder and CEO, Biotricity. "By incorporating medically relevant, clinical-grade data into wearable solutions, problems related to both accuracy and reliability can be reduced and the devices can be seamlessly integrated into the world of medicine."