Anumana announced today that it received FDA breakthrough device designation for its pulmonary hypertension (PH) early detection algorithm.
Cambridge, Massachusetts-based Anumana, formed by Mayo Clinic and nference and launched in 2021, designed its AI-enhanced, electrocardiograph (ECG)-based PH early detection algorithm as a precise, non-invasive screening tool to provide earlier diagnosis for patients with PH that may otherwise go unnoticed until the disease has advanced.
The algorithm leverages 12-lead ECGs and is enabled by the nference platform that provides insight from more than 6 million de-identified patient records, including over 8 million ECGs. It analyzes the voltage-time data and within seconds provides a prediction of the likelihood of PH, reducing the time between initial symptoms and the first evaluation for PH via targeted cardiac imaging.
According to a news release, the algorithm was developed through a collaboration between data scientists and physicians at Anumana, Janssen Research & Development and Mayo Clinic. The company said that if approved, its early detection algorithm will be offered as Software as a Medical Device (SaMD) that can be downloaded on a physician’s smartphone, tablet or computer, or accessed via the cloud through an electronic health record or ECG information management system interface.
“Electrophysiology waveforms hold immense untapped potential for detecting diseases earlier in their natural history, particularly for conditions in which earlier diagnosis and therapeutic intervention can prolong survival and improve quality of life,” Anumana and nference co-founder and CSO Venky Soundararajan said in the news release. “The FDA’s breakthrough device designation for Anumana’s PH early detection algorithm is one step forward for the field of ECG AI overall, and more saliently, a giant leap forward for PH patients.”
The algorithm is Anumana’s second to receive a breakthrough nod, with its low ejection fraction algorithm (developed by Mayo Clinic and licensed by Anumana) garnering a nod in 2019, plus FDA emergency use authorization (EUA) for COVID-19 in 2020.