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Accuracy of Wearable Medical Devices and FDA Clearance

Tuesday, October 18, 2016 Medical Gadgets J E 4
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NEW YORK, October 18, 2016 /PRNewswire/ --

Wrist wearable fitness trackers have gained a lot of popularity over the last few years with a wide range of customers. While popular, the question is whether or not wrist worn fitness trackers and heart monitoring devices are accurate? According to a research conducted by Cleveland Clinic physicians, such devices are not as accurate as chest-worn heart monitors. Biotricity Inc. (OTC: BTCY), Natus Medical Inc. (NASDAQ: BABY), Fitbit Inc. (NYSE: FIT), Koninklijke Philips NV (NYSE: PHG), Medtronic PLC (NYSE: MDT)

The research led by cardiac surgeon Marc Gillinov, MD, explains how such devices work. The chest-worn monitors are similar to electrocardiogram (EKG), which doctors use for diagnostic purposes. The chest-worn heart monitor has two parts - a transmitter, and a receiver worn on the wrist like a watch. The transmitter picks up the electric signal and then sends an electromagnetic signal containing heart rate data to the receiver, which then displays the heart rate.

Biotricity Inc. (OTCQB: BTCY) announced today that the company 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 diagnose and manage chronic diseases, Biotricity seeks to revolutionize the health industry by bridging the gap in chronic care management. Biotricity Inc. is a healthcare technology company dedicated to delivering innovative, medically relevant biometric remote monitoring solutions

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."

"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."

Fitbit Inc. (NYSE: FIT) popularity maybe slowing over the last year as competition in the sector has intensified. Fitbit's possible solution to problem is moving from fitness trackers towards more sophisticated medical devices. As of right now, the company's devices did not impress the Cleveland Clinic physicians. According to the research Fitbit Charge HR underestimated heart rate during vigorous exercises. Fitbit's push into the medical field will test the accuracy of the company's future devices, as it will involve the FDA and their approval process.

For more professional medical purposes, for example in a hospital setting, heart rate monitoring medical devices are also quite diverse. Natus Medical Inc. (NASDAQ: BABY) is in the newborn care business. The company provides products and services used for the screening, diagnosis, detection, treatment, monitoring and tracking of common medical ailments in newborn care. The company has particularly innovative with monitoring devices. One of the products, the Pocket-Dop 3 is a valuable tool for monitoring the fetal heartbeat.

Companies like Koninklijke Philips NV (NYSE: PHG) and Medtronic PLC (NYSE: MDT) have been the medical devices business for decades, and it was only a matter of time until they capitalize on wearable devices. Back in 2014 Medtronic acquired Corventis, which made noninvasive cardiac sensors. Medtronic then announced its first medical wearable device, the SEEQ Mobile Cardiac Telemetry (MCT) System. Most of the devices today are manufactured with the sophisticated sensors, which monitor metabolic changes and generate results in seconds.

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