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FDA clears next-gen software to detect, identify heart murmurs

July 12, 2022

Eko Technologies announced the FDA has cleared its next-generation software for detecting and identifying heart murmurs in adult and pediatric patients.

According to a company release, the software (Eko murmur analysis software) combines murmur analysis artificial intelligence with its digital stethoscopes and is the first smart stethoscope cleared to identify and differentiate innocent and structural murmurs associated with valvular heart disease.

“Combining pathologic murmur detection with the stethoscope, a tool already deeply embedded in the practice of medicine, will allow for more accurate and efficient screening of heart valve disease in the community,” Patrick McCarthy, MD, executive director of the Bluhm Cardiovascular Institute at Northwestern Medicine, said in the release. “Eko’s platform will help uncover early valvular heart disease in millions of people worldwide who may otherwise be missed, and make a significant impact on our ability to treat patients with life-saving interventions.”

The software is reported to have an overall sensitivity of 85.6% and specificity of 84.4% to detect valvular heart disease, and among adults aged 18 years and older, the system identified structural murmurs with a sensitivity of 90.2% and specificity of 90.6%, according to the release.

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