Shots:

• Pfizer & Anumana (founded in 2021 in collaboration with the Mayo Clinic Platform) collaborated to develop AI-ECG to enable the early identification of patients who may be at risk of cardiac amyloidosis.
• Anumana will be responsible to conduct a clinical validation trial and seek De Novo classification for the algorithm as a Software-as-a-Medical-Device (SaMD) and focus to gain regulatory clearance in the US, EU & Japan
• The agreement will strengthen Anumana’s efforts to implement AI-enabled early detection software that can reveal signals from ECGs. Additionally, Anumana has licensed Mayo Clinic AI-ECG algorithms for low ejection fraction, pulmonary hypertension & hyperkalemia, all of which received BTD from the US FDA

Ref: Businesswire | Image: Pfizer