Health technology company Anumana and Pfizer have signed a multi-year agreement to develop an artificial intelligence electrocardiogram (AI-ECG) algorithm for the early detection of cardiac amyloidosis.
Under the deal, Anumana will carry out a clinical validation trial and seek De Novo classification for the new AI-ECG algorithm as a Software-as-a-Medical-Device (SaMD).
The new AI-ECG algorithm will be designed for detecting patients who may be at risk of cardiac amyloidosis, which is a progressive, and underdiagnosed rare disease that leads to heart failure.
Anumana will also obtain regulatory approval for the algorithm as a SaMD to detect cardiac amyloidosis in Europe, Japan, and the US.
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 company stated that the research deal with Pfizer will help deepen its efforts in implementing AI-enabled early detection software, which can help in revealing the signals from ECGs that cannot be interpreted by humans.
The non-invasive, painless 100-year-old ECG test gives the potential to AI-ECG algorithms to reach more patients earlier.
Founded last year, Anumana licensed AI-ECG algorithms from Mayo Clinic for low ejection fraction, hyperkalemia, and pulmonary hypertension.
All the algorithms have received breakthrough device designation from the US Food and Drug Administration (FDA).
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.”