Platform to predict future AF/atrial flutter nets breakthrough device designation - Healio

March 24, 2021

1 min read

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Disclosures: Dudley is an employee of Tempus. Fornwalt is an employee of Geisinger.

Tempus announced the FDA has granted a breakthrough device designation to its ECG analysis platform for the identification of atrial fibrillation or atrial flutter, developed in collaboration with Geisinger.

The platform (Tempus ECG Analysis Platform, Tempus and Geisinger) is designated for use in patients aged 40 years and older who do not have preexisting or concurrent AF or atrial flutter but have elevated risk for stroke. According to a press release, the platform analyzes the results of a 12-lead ECG administered as part of routine care to provide clinicians with insight into a patient's risk of future AF or atrial flutter.

FDA HQ in Washington — *Source: Adobe Stock*

Under the Breakthrough Devices Program, the FDA will prioritize the review of the technology after an application for approval is filed.

“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,” Joel Dudley, PhD, chief scientific officer of Tempus, said in the release.

According to the release, there are currently no available devices to identify asymptomatic patients without a known history of cardiac arrhythmia who are at elevated risk for future AF.

“Much of what we do as clinicians relies on predicting the future. Geisinger and Tempus are working together to make smarter, more accurate predictions about future clinical events,” Brandon Fornwalt, MD, PhD, chair of department of translational data science and informatics at Geisinger, said in the release. “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.”