Health technology company Anumana has received breakthrough device designation from the US Food and Drug Administration (FDA) for its ECG-AI algorithm to detect cardiac amyloidosis.
The artificial intelligence electrocardiogram (AI-ECG) algorithm is designed to facilitate earlier identification of the heart condition.
In 2022, Anumana and Pfizer established a multi-year research partnership to develop ECG-AI solutions. The former partnered with Mayo Clinic to develop the ECG-AI algorithm.
The health technology firm said that the breakthrough device designation is an important regulatory milestone under the agreement with Pfizer and offers an accelerated pathway for regulatory review.
Mayo Clinic cardiovascular medicine department chair Paul Friedman said: “The use of AI algorithms to identify subtle signals in ECGs that are imperceptible to humans stands to transform cardiovascular medicine by allowing us to detect disease early, in more easily treated stages, potentially avoiding serious consequences.
“It is encouraging to see an algorithm that can aid in identification of cardiac amyloidosis receive Breakthrough Device Designation, as it recognises the importance of having new tools to detect rare cardiac diseases in ways never before possible.”
Anumana, which is a portfolio company of nference, aims to obtain regulatory approval for the algorithm for the identification of cardiac amyloidosis in the US, Europe, and Japan.
Additionally, the health technology company intends to carry out a retrospective clinical validation study and pursue De Novo classification for the algorithm as Software as a Medical Device (SaMD). The company also plans to integrate the solution into existing clinical workflows.
Anumana and nference co-founder and chief scientific officer Venky Soundararajan said: “The ubiquitous nature of the painless, non-invasive Electrophysiology tests gives ECG-AI algorithms the potential to reach a larger number of patients earlier, something clinicians have long hoped for.
“Receiving the FDA Breakthrough Device Designation for our Cardiac Amyloidosis ECG-AI Algorithm recognises the significant potential of this tool to detect disease early.”
The firm has already secured breakthrough device status for algorithms that enable early identification of low ejection fraction, pulmonary hypertension, and hyperkalaemia.
