The partnership will support the development of a new algorithm and identify at-risk patients.
Artificial intelligence (AI) health technology company, Anumana, will collaborate with Pfizer to develop an artificial intelligence electrocardiogram algorithm (AI-ECG), which enables the early detection of cardiac amyloidosis.
Based on a multi-year agreement, Anumana will embark on a clinical validation trial, while pursuing De Novo classification for the algorithm as a ‘Software-as-a-Medical-Device’ (SaMD). It also aims to gain regulatory approval for the detection of cardiac amyloidosis across Europe, the US and Japan.
The research partnership will support Anumana’s efforts to implement AI-enabled early detection software. Critically, the technology reveals signals from ECGs that humans cannot usually interpret. Furthermore, the nature of the painless, non-invasive 100-year-old ECG test gives AI-ECG algorithms the potential to reach a larger number of patients earlier.
David McMullin, a chief business officer at Anumana, reflected: “The challenge in diagnosing cardiac amyloidosis can prevent patients from getting treatment while the disease continues to progress.”
He added: “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.”
Paul Friedman, chair of Anumana’s Mayo Clinic board of advisors, concluded: “AI-ECG solutions alert clinicians to humanly imperceptible patterns in ECG signals, providing an early warning for serious occult or impending disease.”
He added: “This stands to improve the lives of people with cardiac amyloidosis by improving the speed of triage and care of this group.”
Cardiac amyloidosis is a serious, progressive and underdiagnosed rare disease that leads to heart failure. In patients with the condition, heart walls become stiff, making it difficult for the left ventricle to relax and fill with blood, hampering its ability to squeeze and pump blood out of the heart.