FDA Radiology AI Devices

HYPER DLR is a software-only device that applies a pre-trained convolutional neural network to reduce noise in fluorodeoxyglucose (FDG) PET images. It improves image quality by distinguishing and removing noise components while preserving image details, aiding radiologists and nuclear medicine physicians in better image interpretation.

The Biograph Vision and Biograph mCT PET/CT systems from Siemens are advanced imaging machines that combine CT and PET technologies to produce high-resolution images showing both anatomical structures and physiological functions. These systems help healthcare professionals detect, localize, diagnose, and stage various diseases including cancer, cardiovascular, and neurological disorders, and also assist with radiotherapy and interventional procedures.

SubtlePET is a software product that uses deep neural network-based AI algorithms to reduce noise and enhance the structural quality of PET images, including PET/CT and PET/MRI scans. It integrates into existing clinical workflows by acting as a DICOM node to process and forward enhanced images, helping radiologists and nuclear medicine physicians better visualize and analyze PET scans for improved diagnostic confidence.