FDA approvals

New ECG device aimed at risk identification in young athletes

Cardea Associates recently announced FDA approved a new ECG device, CardeaScreen, designed for use during pre-participation exams for young athletes aged 14 years and older, according to a press release.

The handheld device connects wirelessly via Bluetooth to analysis software that runs on a standard Windows-based personal computer. The software allows physicians to input responses to specific pre-participation exam questions developed by the American Heart Association and enter patient demographic information, previous symptoms of cardiac disease and echocardiographic data when available. The real-time recording screen displays all ECG trace data to help the clinician correct patient motion and other noise that can degrade ECG quality, according to information in the release.

Additionally, CardeaScreen is associated with a low rate of false positive results, according to the company.

"False positive results can have costly and devastating effects on an athlete and their family," David Hadley, PhD, co-founder of Cardea Associates, stated in the release. "We developed CardeaScreen to make heart screening more accurate, accessible and affordable, with the ultimate goal of identifying cardiac conditions early on to help save lives."

Cardea Associates recently announced FDA approved a new ECG device, CardeaScreen, designed for use during pre-participation exams for young athletes aged 14 years and older, according to a press release.

The handheld device connects wirelessly via Bluetooth to analysis software that runs on a standard Windows-based personal computer. The software allows physicians to input responses to specific pre-participation exam questions developed by the American Heart Association and enter patient demographic information, previous symptoms of cardiac disease and echocardiographic data when available. The real-time recording screen displays all ECG trace data to help the clinician correct patient motion and other noise that can degrade ECG quality, according to information in the release.

Additionally, CardeaScreen is associated with a low rate of false positive results, according to the company.

"False positive results can have costly and devastating effects on an athlete and their family," David Hadley, PhD, co-founder of Cardea Associates, stated in the release. "We developed CardeaScreen to make heart screening more accurate, accessible and affordable, with the ultimate goal of identifying cardiac conditions early on to help save lives."