• FDA Clears First Six-Lead Personal ECG

    KardiaMobile 6L coming in June

    AliveCor's second-generation KardiaMobile 6L was granted FDA clearance, the company said, making it the first six-lead personal ECG allowed into the U.S. market.

    The device has the same design as the existing single-lead KardiaMobile, with the addition of an electrode placed at the bottom of the device. Users place their thumbs on each of the two top electrodes and press the bottom electrode against their left knee or ankle.

    Existing personal ECGs on the market like the Apple Watch's ECG app utilize single-lead technology.

    With six leads, the smartphone-compatible KardiaMobile 6L is able to detect a broader range of arrhythmias, according to an AliveCor press release.

    AliveCor said it will bring the device to stores starting mid-June.

    "I am impressed with the quality and [simplicity] of 6-lead smartphone ECG tracings which will unquestionably sharpen our ability to diagnose heart rhythm and conduction abnormalities. It's a welcome and needed step forward for mobile heart diagnostics," said Eric Topol, MD, of Scripps Health in La Jolla, California, in the company's statement.

    Additionally, the six-lead device is reportedly able to measure the QT interval, according to a previous AliveCor announcement citing a study presented at the American College of Cardiology's annual meeting this year.


    Read the original article Medpage Today: FDA Clears First Six-Lead Personal ECG


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