Patent US 11,412,978 B2 describes the technology as an information processing system to reduce labor of medical staff in determining heart failure stage.
The system references data from hundreds of thousands of electrocardiograms interpreted by clinicians to determine heart failure stage.
The Simplex Quantum processor executes a software program to determine heart failure stage using deep learning methodology.
In the current diagnostic process, a clinician detects heart failure by obtaining a patient's electrocardiogram and clinical information including heart rate and respiratory rate. Determining the stage of heart failure is an additional, often time-consuming step.
US patent registration follows registration in Japan and filing in countries worldwide. Simplex Quantum technology has not yet received US Food and Drug Administration clearance for marketing in the US.
With its pre-submission application to the FDA, the company has initiated the regulatory pathway to market of its technology as a medical device in the US.
Founded in 2014, Simplex Quantum develops technology in collaboration with partners including the University of Tokyo Hospital and Japan's Agency for Medical Research and Development.
According to the Heart Failure Society of America, approximately 6.5 m Americans over age 20 have heart failure.
One study estimates 960,000 new cases every year. Heart failure may contribute to up to 36% of all cardiovascular disease deaths.
It remains the leading cause of hospitalization among Medicare patients, producing a significant burden on our health system.
Medical providers order an echocardiogram to help determine a patient's stage of heart failure, a chronic condition that gets worse with time and has four stages, from "high risk of developing heart failure" to "advanced heart failure."
The patient's stage helps determine the course of treatment.
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