Accuracy of Wearable Medical Devices and FDA Clearance

Tuesday, October 18, 2016 Medical Gadgets
Email Print This Page Comment bookmark
Font : A-A+

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.

Subscribe Now! Watch us report from NYSE

For "The Latest Buzz in Financial News", SIGN UP & Visit:

Follow us on Twitter for real time Financial News Updates:

Follow and talk to us on Instagram:

Facebook Like Us to receive live feeds:

About, a leading financial news informational web portal designed to provide the latest trends in Market News, Investing News, Personal Finance, Politics, Entertainment, in-depth broadcasts on Stock News, Market Analysis and Company Interviews. A pioneer in the financially driven digital space, video production and integration of social media, creates 100% unique original content. also provides financial news PR branding, marketing and advertising for third parties for disseminating news and original content through our unique media platform that includes Newswire Delivery, Digital Advertising, Social Media Relations, Video Production, Broadcasting, and Financial Publications.

Please Note: is not a financial advisory or advisor, investment advisor or broker-dealer and do not undertake any activities that would require such registration. The information provided on (the "Site") is either original financial news or paid advertisements provided [exclusively] by our affiliates (sponsored content),, a financial news media and pr marketing firm enters into service agreements with the companies which are the subject to the articles posted on the Site for advertising such companies. has signed a four month financial news pr services agreement for ten thousand dollars directly from the biotricity inc. We are not an independent news media provider and therefore do not represent or warrant that the information posted on the Site is accurate, unbiased or complete. receives fees for producing and presenting high quality and sophisticated content on this site along with other financial news pr media services. Our fees may be either a flat cash sum or negotiated number of securities of the companies featured on this site, or a combination thereof. The securities are commonly paid in segments, of which a portion is received upon engagement and the balance is paid on or near the conclusion of the engagement. agreed to a four month financial news pr services agreement for ten thousand restricted shares and twenty thousand warrants directly from biotricity inc. does not undertake to update any of the information on the Site or continue to post information about any companies the information contained herein is not intended to be used as the basis for investment decisions and should not be considered as investment advice or a recommendation. The information contained herein is not an offer or solicitation to buy, hold or sell any security., members and affiliates are not responsible for any gains or losses that result from the opinions expressed on the Site, company profiles, quotations or in other materials or presentations that it publishes electronically or in print. Investors accept full responsibility for any and all of their investment decisions based on their own independent research and evaluation of their own investment goals, risk tolerance, and financial condition. By accessing this website and any pages thereof, you agree to be bound by the Terms of Use and Privacy Policy, as may be amended from time to time. None of the content issued by constitutes a recommendation for any investor to purchase, hold or sell any particular security, pursue a particular investment strategy or that any security is suitable for any investor. This publication is provided by Each investor is solely responsible for determining whether a particular security or investment strategy is suitable based on their objectives, other securities holdings, financial situation needs, and tax status. You agree to consult with your investment advisor, tax and legal consultant before making any investment decisions. We make no representations as to the completeness, accuracy or timeless of the material provided. All materials are subject to change without notice. Information is obtained from sources believed to be reliable, but its accuracy and completeness are not guaranteed. For our full disclaimer, disclosure and Terms of Use. Please visit:

For further information:

Media Contact: Danny A, , +1-877-601-1879


Post your Comments

Comments should be on the topic and should not be abusive. The editorial team reserves the right to review and moderate the comments posted on the site.
* Your comment can be maximum of 2500 characters
I agree to the terms and conditions

News A - Z


News Search

Medindia Newsletters

Subscribe to our Free Newsletters!

Terms & Conditions and Privacy Policy.

Find a Doctor

Press Release Category

Press Release Archive

Stay Connected

  • Available on the Android Market
  • Available on the App Store