Anumana has received US Food and Drug Administration (FDA) Breakthrough Device Designation for its artificial intelligence (AI)-enhanced, electrocardiogram (ECG)-based Pulmonary Hypertension (PH) Early Detection Algorithm.

The accurate, non-invasive screening tool aids in addressing an unmet need for early detection of PH in patients.

PH could otherwise go undiagnosed until the illness has progressed, delaying the initiation of therapy, reducing the efficacy of treatment and negatively affecting patient outcomes.

The AI-enhanced ECG algorithm is intended to diagnose PH effortlessly and safely at an early stage by using the broad availability of 12-lead ECGs in primary care, urgent care and emergency room settings.

The algorithm is powered by the nference platform, which offers insight from more than six million de-identified patient records, including more than eight million ECGs.

This platform was developed under a partnership between data scientists and physicians at Anumana, Janssen Research and Development, and Mayo Clinic.

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Last year, nference created Anumana with the support of Mayo Clinic Platform for developing and marketing AI-enabled algorithms.

On obtaining approval, the AI-enhanced ECG PH algorithm will be provided as Software as a Medical Device (SaMD).

It will be possible for physicians to download the SaMD onto a smartphone, tablet or computer, or access it through the Cloud using an Electronic Health Record or ECG Information Management System interface.

The algorithm uses a traditional 12-lead ECG to assess voltage-time data and offer a prediction of chances of PH within seconds.

This approach lowers the time between early symptoms and first diagnosis for PH through targeted cardiac imaging.

Anumana co-founder and chief scientific officer Venky Soundararajan said: “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.

“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.”