Heart health is an ongoing issue in the United States. While there are many methods to keep a heart healthy, sometimes there is a need for additional assistance. That assistance comes in form of medical devices. There are many medical devices related to heart health. Some devices are implanted to help a heart keep beating while others are meant to restores a heart’s normal rhythm. The FDA approves and regulates these devices in order to combat cardiovascular diseases and conditions.

One rather ingenious device is the heart stent. A fairly simplistic device, the stent is nothing more than a small metal tube that is inserted into an artery in order to improve blood flow.[1] Despite its simplicity, a stent is still subject to medical devices regulations under the FDA. Stents are actually considered a Class III device by the FDA,[2] which means they are subject to rather strict regulations to even get approved for the market. While these regulations may seem excessive, it is important to remember that a faulty stent can just as easily hurt a patient as it can help one.

Another type of device is an Automated External Defibrillator or AED for short. These devices are actually fairly common and can be found for sale to the public. The reason for this is that the function of a defibrillator is to restore heart rhythm for someone who has gone into cardiac arrest.[1] While common, these devices actually require Pre-Market Approval by the FDA, one of the strictest approval pathways.[3]  This is done in order to ensure that a faulty AED does not make it to the market, which could more harm than good.

Heart disease remains one of the deadliest issues in the United States. Thankfully, with the help of researchers across the world, new technologies and techniques are constantly being developed in order to combat heart diseases and conditions. If you need help getting your heart health-related medical device approved contact EMMA International. The team of quality and regulatory specialists at EMMA International can provide expert guidance on getting a device approved for market not only in the United States but around the world. EMMA International provides Full Circle Consulting services, give us a call at 248-987-4497 or email us at info@emmainternational.com to get in touch with our team of experts today.


[1] FDA (February 2021) FDA-Approved Devices that Help Keep the Heart Beating, Retrieved 02/06/2022 from https://www.fda.gov/consumers/consumer-updates/fda-approved-devices-help-keep-heart-beating

[2] FDA (June 2018) Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems – Guidance for Industry and FDA Staff, Retrieved 02/06/2022 from https://www.fda.gov/regulatory-information/search-fda-guidance-documents/non-clinical-engineering-tests-and-recommended-labeling-intravascular-stents-and-associated-delivery

[3] FDA (February 2021) How AEDs in Public Places can Restart Hearts, Retrieved 02/06/2022 from https://www.fda.gov/consumers/consumer-updates/how-aeds-public-places-can-restart-hearts

Gabe Kadoo

Gabe Kadoo

Mr. Kadoo is a Quality Engineer at EMMA International. He has experience in statistical analysis, performance improvement, quality assurance, and value stream mapping in the clinical setting. Mr. Kadoo also has experience as a clinical researcher and medical technologist. Mr. Kadoo holds a Bachelor of Science in Biology and a Master of Public Administration with a concentration in Healthcare Administration. He is also a Six Sigma Green Belt.

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