iCardio.ai announces FDA 510(k) Clearance for CardioVision. This is the company’s second FDA clearance.
CardioVision can automatically detect aortic stenosis, a disease affecting 1.5M Americans with a one-way prognosis, whose only intervention is a valve replacement. Today, the only way aortic stenosis is diagnosed is by manual review of an echocardiogram by a human. The company is challenging a new future of echocardiography with #AI.
Related: CeriBell gets FDA nod for the Clarity neonate seizure detection algorithm
CardioVision was designated as a Breakthrough Device by the FDA for its capability to automatically detect aortic stenosis in healthcare settings where identifying aortic stenosis might be missed.
The algorithm has shown extremely compelling performance in outpatient imaging environments, where image quality can be various and poor, demonstrating extremely high sensitivity and specificity, making it well-suited for automated interpretation of echocardiography.
The company envisions a future where all echocardiograms taken in the United States could instantly pass through CardioVision the moment the echo is taken for assessment of aortic stenosis, which can in turn increase disease detection and expedite treatment.
Echocardiography is the most ubiquitous imaging modality in cardiology, and iCardio.ai’s team won’t stop until they automate every component of it with AI capable of outperforming human interpretation.
