Digital health technology firm Anumana has signed a multi-year agreement with pharma major Pfizer to develop an artificial intelligence electrocardiogram algorithm (AI-ECG) for the early detection of cardiac amyloidosis.

The Mayo Clinic spinout, which is currently a portfolio company of nference, will carry out a clinical validation trial and seek De Novo classification for the algorithm as a Software-as-a-Medical-Device (SaMD).

Anumana aims to obtain regulatory clearance for the algorithm as a SaMD for the identification of cardiac amyloidosis in the US, Japan, and Europe.

Anumana chief business officer David McMullin said: “The challenge in diagnosing cardiac amyloidosis can prevent patients from getting treatment while the disease continues to progress.

“We believe this collaboration will demonstrate the power of Anumana’s AI-ECG algorithms to help clinicians intervene earlier, giving them greater ability to improve patient outcomes and prolong lives.”

The health technology firm said that the research agreement with Pfizer will help increase its efforts to implement AI-enabled early detection software that can reveal signals from ECGs that cannot be interpreted by humans. The 100-year-old painless, non-invasive ECG test, which is widely used, gives the potential to AI-ECG algorithms to reach more patients earlier, said Anumana.

Mayo Clinic cardiovascular medicine department chair Paul Friedman said: “AI-ECG solutions alert clinicians to humanly imperceptible patterns in ECG signals, providing an early warning for serious occult or impending disease.

“This stands to improve the lives of people with cardiac amyloidosis by improving the speed of triage and care of this group.”

Anumana licensed AI-ECG algorithms from Mayo Clinic for low ejection fraction, hyperkalemia, and pulmonary hypertension, all of which have been granted breakthrough device designation from the US Food and Drug Administration (FDA).

Last month, the company acquired NeuTrace, which develops AI applications for assessing electrical signals in the heart.