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November 19, 2021

FDA grants 510(k) clearance for Lunit AI solution to detect breast cancer

The new AI solution Lunit INSIGHT MMG provides the location information of detected lesions.

The US Food and Drug Administration (FDA) has granted 510(k) clearance for Lunit’s artificial intelligence (AI) software, Lunit INSIGHT MMG, for detecting breast cancer.

Developed using Lunit’s deep learning technology, the new AI solution accurately analyses mammography images to detect lesions that could indicate breast cancer.

It also provides the location information for any detected lesions in the form of outlines and heatmaps.

An abnormality score is generated for each breast side that reflects Lunit INSIGHT MMG’s calculation of the presence of detected breast cancer.

Lunit CEO Brandon Suh said: “I am delighted to deliver the great news and to introduce Lunit INSIGHT MMG to healthcare professionals and institutions across the US.

“With our AI solution, we hope to increase the efficiency and accuracy of mammography screening as well as chest x-ray triaging. We can assist radiologists diagnose diseases at an earlier stage, helping patients be treated at the right time.”

The company stated that Lunit INSIGHT MMG is trained with data obtained from more than 240,000 mammography cases, of which up to 50,000 cases were related to breast cancer.

It also claimed that the product is known to show excellent performance in the detection of breast cancer at an early stage.

The AI solution was found to have a sensitivity that was approximately 15% higher than two other commercialised AI algorithms, according to a study which was published last year in JAMA Oncology.

It has been CE marked and approved for commercial sales in more than 35 countries across the world.

Recently, Lunit received 510(k) clearance from the US FDA for its Lunit INSIGHT CXR Triage, an AI-powered chest x-ray triaging solution.

Now, the Lunit INSIGHT CXR Triage solution is commercially available in the US.

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