Digital Health App Vendor AliveCor Awarded Breakout Status by FDA

Sep 18, 2018 | Blood Diagnostic Test

Christina Farr of CNBC reports that AliveCor, a Silicon Valley start-up that develops technology to monitor people’s heart health, on Monday received “breakthrough device” designation from the U.S. Food and Drug Administration for developing a new way to detect high blood potassium levels without requiring any blood. AliveCor worked with doctors at the Mayo Clinic, which is also an investor in the company, to develop a new technology that looks for a dangerous condition called hyperkalemia without requiring any blood from the patient. It instead looks for patterns in electrocardiograms (ECGs or EKGs), which are essentially recordings of the electrical signals of the heart. Founded in 2010, AliveCor has raised $43.5 million according to Crunchbase.  liveCor has a device and application that will turn any smartphone into a clinical-quality electrocardiogram (ECG) recorder.

AliveCor is pioneering the creation of FDA-cleared ‘machine learning’ techniques to enable proactive heart care and is recognized around the world for transforming cardiac care. The FDA-cleared Kardia Mobile is the most clinically validated mobile ECG solution on the market and is recommended by leading cardiologists and used by people worldwide for accurate ECG recordings. This simple-to-use mobile device and app-based service provides instant analysis for detecting atrial fibrillation (AF) and normal sinus rhythm in an ECG. Kardia Pro is the first AI-enabled platform for doctors to monitor patients for the early detection of atrial fibrillation, the most common cardiac arrhythmia that leads to a five times greater risk of stroke. AliveCor was recognized by Fast Company as one of 2017’s most innovative companies in health. AliveCor is a privately-held company headquartered in Mountain View, California.

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