AI-enhanced platform for detecting cardiac amyloidosis nets FDA breakthrough device status
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Ultromics announced it has received FDA breakthrough device status for its artificial intelligence-enhanced platform for detecting cardiac amyloidosis on echocardiograms.
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 product (EchoGo Amyloidosis), intended as a module within the company’s imaging platform (EchoGo), is designed for earlier diagnosis of patients with amyloidosis, according to a company press release.
"While treatments exist to help slow or halt the progression of cardiac amyloidosis, underdiagnosis in the early stages of disease is a huge challenge," Najat Khan, PhD, chief data science officer and global head of strategy and operations at Janssen Research and Development, LLC, said in the release. "When applied to routine tests like echocardiograms, artificial intelligence is demonstrating exciting potential to help facilitate earlier disease detection — with the goal of connecting patients with treatment sooner and, ultimately, driving better health outcomes."
The device could be approved for commercialization as soon as early 2024, according to the release.
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