FDA clears AI software for detecting untreated pulmonary hypertension in 12-lead ECGs
Tempus AI, a Chicago-based medtech company, has secured U.S. Food and Drug Administration (FDA) clearance for a new artificial intelligence (AI)-powered software device that flags signs of pulmonary hypertension (PH) in 12-lead electrocardiograms (ECGs).
The newly cleared software, Tempus ECG-PH, explores a patient’s resting 12-lead ECG and then alerts clinicians if their mean pulmonary artery pressure exceeds 20 mmHg. It was designed to evaluate any adults 40 years old or older or adults younger than 40 who present with cardiovascular symptoms.
Tempus ECG-PH is not intended to be used as a standalone diagnostic tool. Instead, clinicians are urged to always interpret its findings in the context of all other diagnostic information before making any treatment decisions.
“PH has historically been underdiagnosed because early symptoms are non-specific and gold-standard diagnostics are invasive,” Brandon Fornwalt, MD, PhD, senior vice president of cardiology at Tempus, said in a statement. “This third FDA-cleared cardiovascular device reflects our broader goal of using AI to help identify patients across the spectrum of cardiovascular disease. We’re building tools that can help clinicians surface risk earlier.”
Tempus now has three FDA-cleared algorithms, including one for atrial fibrillation and another for low ejection fraction.
Tempus working closely with Medtronic
In addition to this latest clearance from the FDA, Tempus has also been working closely with Medtronic on exploring the potential impact of AI-enabled clinician alerts. The ALERT trial found that patients treated with AI alerts were 27% more likely to have their case evaluated by a multidisciplinary care team. They also experienced a 40% increase in their odds of receiving TAVR or another valve interventions.
“The ALERT trial shows that data-driven clinical decision support positively impacts patients suffering from valvular heart disease,” Fornwalt said in a statement back in April. “Being a part of this work further underscores our commitment at Tempus to building technology that helps every patient have the chance to receive the best possible care.”
Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.