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AngelMed Announces FDA Approval of the Enhanced Real-Time Cardiac Monitor for Acute Coronary Syndrome (ACS) Events
The AngelMed Guardian® System alerts people with high-risk ACS to seek medical attention.
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CIO Applications | Friday, July 02, 2021

The AngelMed Guardian® System alerts people with high-risk ACS to seek medical attention.
FREMONT, CA: The FDA approved the second-generation AngelMed Guardian® device today, according to Angel Medical Systems, Inc. (dba AngelMed), a proactive diagnostics firm focusing on advancing long-term management of the high-risk coronary disease. The AngelMed Guardian System is the first implantable cardiac detection monitor and patient-warning system for ACS episodes, such as silent heart attacks. In addition, the new, second-generation smartphone features improved ease-of-use features and an updated, long-life battery that could potentially quadruple the device's lifespan.
A cardiologist implants the AngelMed Guardian device subcutaneously during a low-risk outpatient surgical procedure. The AngelMed Guardian continually monitors the heart's electrical activity 24 hours a day, using a unique algorithm to look for electrical alterations that could indicate an upcoming ACS event. Compared to patient symptoms alone, the AngelMed Guardian gadget gives a more accurate diagnosis of a life-threatening ailment.
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"Patients who have had a prior ACS event often remain at high-risk of a recurrent event. Even those patients who are on alert for another potential cardiac event may delay seeking treatment," said Dr. C. Michael Gibson M.D., Boston Clinical Research Institute. "The AngelMed Guardian System has demonstrated the ability to identify the earliest signs of an ACS event, including heart attacks, more effectively than patients' symptoms alone, and in patients who do not experience symptoms at all."
"The improved AngelMed Guardian device will have a meaningful effect on the current standard of patient cardiology care for ACS events. Our dedicated team and supporting physicians have worked tirelessly to bring this disruptive technology to market," said AngelMed Chief Executive Officer Brad Snow. "As the first real-time detection device for high-risk heart attack patients, the AngelMed Guardian System provides critical data at the point of care, along with peace of mind for physicians and patients alike."
"Our key learnings based on hundreds of thousands of hours of clinical monitoring data for many ambulatory patients with cardiovascular disease provides a technology platform for future offerings. Our patient-centric approach will drive our research and development," said Dave Keenan, AngelMed chief operating officer.
A myocardial infarction occurs every 40 seconds in the United States. Age, comorbidities, medical history, and the severity of their initial ACS event are the most relevant risk factors for a subsequent cardiovascular event in post-heart attack patients. Unfortunately, despite the medical community's proactive efforts over the last decade to better educate the public on the signs and symptoms of a heart attack, the time from onset of symptoms to arrival at a hospital has remained constant at eight hours.
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