Anumana has received FDA approval for its ECG-AI algorithm designed to support the diagnosis of cardiac amyloidosis at the point of care. This makes it the first and only AI algorithm cleared by the FDA for this severe heart condition, which is often missed by the human eye when looking at electrocardiogram (ECG) data.
“Cardiac amyloidosis can be challenging to detect early, especially when its signs overlap with more common heart conditions,” said Martha Grogan, MD, consultant in cardiovascular medicine at Mayo Clinic and co-principal investigator of the clinical study that supported the approval. “A tool that helps clinicians recognize suspicion of amyloidosis from a routine ECG could support earlier diagnosis and more timely next steps in care.”