AI algorithm for detection of cardiac amyloidosis gains FDA breakthrough device status
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Key takeaways:
- An artificial intelligence-guided algorithm to identify cardiac amyloidosis received a breakthrough device designation from the FDA.
- Earlier identification could improve care of patients with amyloidosis.
Anumana announced it received FDA breakthrough device designation for its artificial intelligence-guided ECG algorithm for the early identification of cardiac amyloidosis.
The breakthrough device designation is intended to expedite the development and review of devices intended to treat a serious condition where preliminary clinical evidence indicates potentially substantial improvement over available devices.
“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,” Paul Friedman, MD, chair of the department of cardiovascular medicine at Mayo Clinic and chair of Anumana’s Mayo Clinic board of advisors, said in the release. “It is encouraging to see an algorithm that can aid in identification of cardiac amyloidosis receive breakthrough device designation, as it recognizes the importance of having new tools to detect rare cardiac diseases in ways never before possible.”
The algorithm was developed in collaboration with Mayo Clinic and the company stated it plans to conduct a retrospective validation trial and pursue de novo classification for the algorithm as software as a medical device.
The algorithm is designed to be integrated into existing clinical workflows, according to a company press release.
“The ubiquitous nature of the painless, noninvasive electrophysiology tests gives ECG-AI algorithms the potential to reach a larger number of patients earlier, something clinicians have long hoped for,” Venky Soundararajan, PhD, co-founder and chief scientific officer of Anumana, said in the release.
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