FDA Clears New AI-Powered Imaging Processing Software for PET/CT

The Food and Drug Administration (FDA) has granted 510(k) clearance for Precision DL (GE HealthCare), an artificial intelligence (AI)-enabled image processing software, which may offer significant improvements in contrast-to-noise ratio (CNR), the accuracy of feature quantification, and the diagnosis of small lesions on positron emission tomography (PET)/ computed tomography (CT).

Engineered with a deep neural network trained on thousands of images via multiple reconstruction methods, Precision DL will be accessible through the Omni Legend PET/CT device (GE HealthCare).

The company said Precision DL offers a variety of imaging enhancement benefits including:

• an average 42 percent increase in the detection of small, low-contrast lesions;

• an average 23 percent improvement in CNR; and

• a 14 percent improvement in the accuracy of feature quantification.

“Precision DL enhances image quality – enabling us to spot small lesions, including on images obtained with very low dose injections and short bedtimes, to potentially start treatment and monitoring early, which might result in improved outcomes,” noted Flavio Forrer, M.D., Ph.D., the chairman of nuclear medicine at Kantonsspital St. Gallen in Switzerland.

(Editor’s note: For related content, see “GE Healthcare Launches Omni Legend PET/CT System at EANM Congress.”)