A Mayo Clinic and Janssen-backed venture has received FDA breakthrough designation for an algorithm designed to enable early detection of pulmonary hypertension.
Anumana Inc. received the breakthrough device designation for its AI-enhanced, ECG-based algorithm screening tool that provides early diagnosis of patients with pulmonary hypertension, according to a May 24 press release.
The tool, which launched in 2021, allows for earlier treatment of patients with pulmonary hypertension and was developed through a collaboration between data scientists and physicians at Anumana, Janssen Research & Development and Rochester, Minn.-based Mayo Clinic.
"Early diagnosis of pulmonary hypertension is paramount due to its progression and potential severity," said Paul Friedman, MD, chair of the department of cardiovascular medicine at Mayo Clinic. "The addition of AI to a standard ECG — a painless, inexpensive, widely used test that is routinely performed — transforms the ECG into a screening tool for pulmonary hypertension, with the opportunity to improve outcomes via early detection by guiding appropriate testing."
If approved, the algorithm will be offered as Software as a Medical Device that can be downloaded on a physician's smartphone, tablet, computer or accessed via cloud services.