FDA grants breakthrough device designation to AI-powered ECG analysis tool

Tempus, a Chicago-based healthcare technology company, announced March 24 that its AI-powered ECG Analysis Platform has received the FDA’s breakthrough device designation.

The platform, developed as part of a collaboration with Geisinger, uses 12-lead ECG data to predict a patient’s future risk of atrial fibrillation (AFib) and atrial flutter. Tempus hopes these insights can help clinicians identify, diagnose and treat heart rhythm issues.

“Every year, hundreds of millions of ECGs are performed in the U.S. to detect cardiac abnormalities as part of routine clinical care,” Joel Dudley, PhD, chief scientific officer for Tempus, said in a statement. “We are making ECGs smarter so that they can also identify the risk of future clinical events of interest, such as AFib, thus enabling clinicians to act earlier in the course of disease and improve patient outcomes.”

“Much of what we do as clinicians relies on predicting the future,” added Brandon Fornwalt, MD, PhD, chair of Geisinger’s department of translational data science and informatics. “Geisinger and Tempus are working together to make smarter, more accurate predictions about future clinical events. This is ultimately about helping patients and fulfilling the promise of precision health by supporting clinical decision making with additional patient-specific information, and we are excited that the FDA recognizes the importance of this work.”

The ECG Analysis Platform is designated as a breakthrough device for treating high-risk patients who are at least 40 years old.

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