Ezra secures FDA 510(k) approval for AI technology that improves MRI
02 Jun 2023
Ezra has created a fast MRI protocol that produces noisy images, which are later processed by Ezra Flash to enhance the image quality, and will use its AI technology to introduce the world’s first 30-minute full body MRI scan
Ezra Flash AI is designed to improve MRI. (Credit: National Cancer InstituteCancer Institute on Unsplash)
Ezra has received the US Food and Drug Administration (FDA) 510(k) approval for Ezra Flash, its new Artificial Intelligence (AI) technology that improves MRI screening.
Ezra Flash is designed to enhance the quality of MR images to help decrease the time required to complete a high-quality scan, thereby reducing MRI cost.
The company has created a fast MRI protocol that produces noisy images, which are later processed by Ezra Flash to enhance the image quality.
Ezra will use its AI technology to introduce the world’s first 30-minute full body MRI scan.
Ezra founder and CEO Emi Gal said: “Over 1.9 million people are expected to be diagnosed with cancer in the U.S. in 2023 according to the American Cancer Society.
“Our mission at Ezra is to detect cancer early for everyone in the world, and I’m really excited about this new AI enabling us to make our scan more affordable.
“By boosting quality while reducing scan time, we’re decreasing our cost for a full body MRI by 30%, and we’re passing these cost savings to our customers.”
The AI-powered solution was trained for using the company’s unique longitudinal MRI dataset that contains hundreds of thousands of MR images in patients and healthy subjects.
It was trained to evaluate the elements of the MRI scan that are essential for creating a complete and accurate image, to enhance image quality in high-speed MRI scans.
The company used a multi-step validation process, where panel of five radiologists analysed the performance of the AI both qualitatively and quantitatively.
Ezra said that it is the world’s first company to leverage AI across all three key components of the cancer screening process, imaging, analysis, and reporting.
The Ezra Flash AI enhances MR image quality, while Ezra Prostate AI aids analysis of MR images of the prostate, and Ezra Reporter AI creates an easily digestible translation of radiology reports.
Sodickson added: “The FDA clearance of Ezra Flash is an important landmark – the beginning of a sea change in how medical imaging is used. Progressive increases in imaging speed over time have already resulted in myriad benefits to patients and physicians.
“Ezra is using MRI as a tool for early detection of cancer prior to the development of symptoms – a safety net of proactive monitoring that has previously only been available to patients with certain well-established risk factors.
“Ezra Flash will increase the accessibility of early-warning MRI, and Ezra’s dataset of repeated scans over time will help it to prevent false positives and ensure that the warnings it provides are appropriate and actionable.”
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