An algorithm has been developed that makes screening for heart failure more accessible—both in traditional clinics and telehealth settings. The algorithm, which was created by digital health company Eko and Mayo Clinic, can use as little as 15 seconds of electrocardiogram (ECG) data to identify Left Ventricular Ejection Fraction (LVEF), a measure that’s commonly used to diagnose patients with heart failure.
In a study published earlier this year, the algorithm was tested on 52,870 patients with 87.5 percent accuracy. That’s good news, but what’s even better is that the FDA just granted “breakthrough status” to the algorithm.
That means the FDA sees the algorithm as a potential solution for an unmet medical need for a life-threatening disease. It will help accelerate the FDA’s regulatory review process. Though it’s too early to say if or when the algorithm will receive FDA clearance, it’s likely we’ll find out soon thanks to the breakthrough status.
