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 scie…