Tempus, a leader in artificial intelligence and precision medicine, today announced that the U.S. Food & Drug Administration (FDA) has granted the company Breakthrough Device Designation for its ECG Analysis Platform, developed in collaboration with Geisinger.
The platform provides clinicians with the ability to identify patients at high risk of developing atrial fibrillation (AFib) or atrial flutter in the next year. The breakthrough designation entitles the platform to an expedited regulatory process with the goal of accelerating deployment to patients, ultimately enabling earlier and more proactive diagnosis of AFib to improve treatment options.
AFib is a leading cause of stroke, and appropriate treatment reduces this risk of stroke by 65%. Unfortunately, people with AFib often have no obvious symptoms, and this leads to irreversible debilitation when they suffer a stroke as their first manifestation of the disease.
The Tempus ECG Analysis Platform is the first device to tackle this challenge by enhancing a widely-used clinical test, the 12-lead ECG, with software that identifies patients at high risk of developing AFib within the next 12 months. Clinicians can then use this knowledge to diagnose and treat AFib earlier, for example through monitoring patients more closely for development of AFib with wearable devices.
A team of scientists and clinicians at Geisinger and Tempus recently published a related study in Circulation, which showed that artificial intelligence can predict risk of new AFib and AFib-related stroke.
The combined team of data scientists and medical researchers used 1.6 million ECGs from 430,000 patients collected over 35 years of patient care at Geisinger to train a deep neural network to predict, among patients without a previous history of AFib, who would develop it within 12 months. In patients with no history of AFib that went on to have an AFib-related stroke, nearly two thirds would have been predicted to be high-risk for AF before the stroke.
"In providing us with Breakthrough Device Designation, the FDA is recognizing the critical need for new, smarter tools that can support clinicians in predicting future clinical events," said Joel Dudley, PhD, Chief Scientific Officer of Tempus. "Every year, hundreds of millions of routine ECGs are performed in the U.S. to detect cardiac abnormalities. We are making ECGs smarter so that they can identify the risk of future, highly treatable clinical events of interest, such as AFib, thus enabling clinicians to act earlier in the course of disease and improve patient outcomes."
Most of what we do as physicians relies on predicting the future. Geisinger and Tempus are working together to make smarter, more accurate predictions about future clinical events, This is ultimately about helping clinicians to fulfill the promise of precision health to give the right treatment to the right patient at the right time, and we are excited that the FDA recognizes the importance of this work."
Brandon Fornwalt, MD, PhD, Chair of Geisinger's Department of Translational Data Science and Informatics
The FDA's Breakthrough Device Program was established to accelerate the availability of transformative medical devices to patients and healthcare providers by speeding up their development, assessment and review, while preserving the statutory standards for premarket review and authorization.
Awards are strictly restricted to innovative devices that provide more effective diagnosis or treatment of life-threatening conditions and that offer significant advantages over the existing standard of care, where no approved or cleared alternatives exist, and where early device availability is in patients' best interests.