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FDA Clearance Saves Lives: The Safety Standard for Small Heart Monitor Devices

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  With an estimated 6 out of 10 Americans with at least 1 chronic disease , medical device precision isn’t optional — it’s lifesaving. Heart disease is one of the most prevalent chronic diseases. In 2019, the American Heart Association reported that almost half of all U.S. citizens were affected by some form of cardiovascular disease (CVD). This number continues to rise, with projections indicating that more than 184 million people will live with CVD within the next 30 years.   Early detection and proactive management are essential to curbing the growing prevalence of CVD. In this context, small heart monitor devices play a vital role, but their value hinges on precision and reliability. That’s why FDA clearance is not just a regulatory checkbox, it’s a critical benchmark for the safety and effectiveness of medical devices, like mini heart monitor devices. This blog will explore why FDA clearance should be your top priority when evaluating a wireless heart monitor patch or ot...
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Cardiovascular Test vs. ECG: What’s the Difference and When Do You Need One?

  When it comes to assessing heart health, two terms that often come up are the cardiovascular test and the ECG (electrocardiogram) . While they may sound similar, they serve different purposes and provide different insights into how your heart is functioning. What Is a Cardiovascular Test? A cardiovascular test is a broad term that refers to any diagnostic exam used to evaluate the function and structure of the heart and blood vessels. These tests include: ECG (Electrocardiogram) Echocardiogram Stress test (treadmill test) Cardiac CT or MRI Blood pressure monitoring Each test offers unique information. For instance, a stress test evaluates heart performance under physical exertion, while an echocardiogram uses ultrasound to examine heart valves and chambers. Cardiovascular tests can be done in clinics, hospitals, or outpatient centers and are typically recommended based on your symptoms or risk factors. What Is an ECG? An ECG , or electrocardiogram, is a specific type of cardiova...
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