AliveCor Heats up Mobile ECG Market with New Data

The release of the ST LEUIS trial data comes on the heels of Apple receiving FDA clearance for an ECG app for the Apple Watch.

A research version of AliveCor’s mobile ECG technology could help rapid diagnosis and treatment of heart attacks, according to a study presented at the 2018 American Heart Association’s Scientific Sessions in Chicago.

The ST LEUIS International Multicenter Study determined that the Mountain View, CA-based company’s smartphone technology can identify the condition with good correlation and high sensitivity compared to a standard-lead ECG.

A total of 204 subjects (age = 60 years, males = 57%, STEMI activation = 45%) were enrolled from 5 international sites. For all interpretable smartphone ECGs (n=190), vs. standard ECGs, the sensitivity, specificity, positive, and negative predictive value for STEMI/LBBB were 0.89, 0.84, 0.70 and 0.95, respectively. Qualitative, interpretable paired ECG evaluations showed 166 (87.4%), 23 (12.0%), and 1 (0.5%) pairs with good, fair and poor correlation, respectively.

The new research indicates that lives could be saved by allowing 12-lead equivalent ECGs to be taken in situations where traditional ECG technology may not be immediately available.

"Rapid diagnosis of STEMI is key to survival for these heart attack victims," principal investigator Joseph Muhlestein MD, a cardiovascular researcher at the Intermountain Medical Center Heart Institute in Salt Lake City, said in a release. "It's vital to immediately identify the type of episode a person is having so they can be properly expedited through the emergency room process. Today, the lack of accessibility to a traditional 12-lead ECG is often a barrier."

Mobile ECG’s have been a hot topic in medtech lately. The discussion was ignited in September, when Apple gained clearance for an ECG App for its Apple Watch Series 4 watch. Another company that sits firmly in the wearable ECG market space is IRhythm Technologies, which was a finalist for Medtech Company of the Year in 2016. The San Francisco-based company received FDA clearance for Zio Patch, a wearable that offers ambulatory monitoring of a patient's heart rhythm for up to 14 days, back in 2011.

 

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