- AliveCor announced Monday it received FDA clearance for what it says is the first personal six-lead electrocardiogram.
- KardiaMobile 6L is intended to provide greater insight into certain heart arrhythmias than a single-lead EKG can provide, AliveCor Chief Medical Officer Jacqueline Shreibati told MedTech Dive in an interview.
- Alongside an April 510(k) clearance for software, indicated to help identify bradycardia and tachycardia, AliveCor is positioning itself to compete with the latest Apple Watch’s EKG function.
The new device is similar to AliveCor’s single-lead Kardia Mobile EKG but has an additional electrode on the bottom of the device to allow a user to take a reading with both thumbs and their knee or ankle.
KardiaMobile 6L, which measures EKG leads I, II, II, aVL, aVR and aVF, is set to launch in June at a price of $149, according to AliveCor.
“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,” Eric Topol, a cardiologist and director of Scripps Research Translation Institute, said in AliveCor’s press release.
AliveCor has more features in the works for its KardiaBand application. Last September the company received FDA breakthrough device designation for software in development meant to use artificial intelligence to detect hyperkalemia, or elevated blood potassium, but using data from an EKG.
AliveCor is not a pilot participant in FDA’s Software Precertification Program, but the company is watching closely as the potential pathway is developed, according to Shreibati.