AliveCor said today that it won FDA clearance for its KardiaMobile 6L six-lead personal ECG device, touting it as the first device of its kind to win FDA clearance.
The Mountain View, Calif.-based company said that the six-lead device features a design consistent with its existing KardiaMobile product, but features an additional two electrodes on the top of the device and one on the bottom.
“KardiaMobile 6L is the most clinically valuable personal ECG ever created, and another significant step in AliveCor’s march to making heart care more convenient, more accessible, and less expensive than ever before,” AliveCor CEO Ira Bahr said in a prepared statement.
The device is designed to be used by placing thumbs on the top two electrodes while the bottom electrodes are placed on the left knee or ankle, AliveCor said, touting that the six-lead device provides a “far superior view of the heart” over single-lead ECGs.
“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,” ‘Deep Medicine’ author and Scripps Research Translational Institute founder and director Dr. Eric Topol said in a press release.
Last month, AliveCor said that it won expanded FDA 510(k) clearance indications for its KardiaMobile personal ECG device, now cleared for detecting bradycardia and tachycardia.
