FDA Radiology AI Devices

IDx-DR is an AI software device designed to help healthcare providers automatically detect more than mild diabetic retinopathy in diabetic adult patients using retinal fundus images. It assists clinicians by analyzing images captured from a specialized retinal camera and providing a diagnostic screening result, thus potentially improving early detection and management of diabetic eye disease.

The syngo.via MI WorkFlows, including Scenium and syngo MBF, is a software suite from Siemens designed to assist healthcare professionals by providing advanced image processing, visualization, and quantitative analysis for multiple medical imaging modalities such as PET, CT, MRI, and SPECT. It supports disease management in oncology, cardiology, neurology, and organ function, helping clinicians interpret complex images and plan treatments more effectively.

The OPTIS Mobile Next Imaging System and OPTIS Integrated Next Imaging System by Abbott Medical are advanced OCT imaging systems designed for use in cardiovascular catheterization labs. Paired with compatible Dragonfly imaging catheters, these devices provide detailed imaging of coronary arteries and physiological measurements to help physicians assess coronary lesions and determine the need for intervention.

Transpara 1.7.0 is an AI software tool designed to assist physicians in interpreting breast imaging exams such as digital mammography and tomosynthesis. It uses deep learning algorithms to detect suspicious calcifications and soft tissue lesions, scoring their likelihood of malignancy to aid diagnosis and improve workflow. It processes images to highlight abnormal areas and provides exam-level cancer likelihood scores, supporting better identification of breast cancer indicators.

The Zio ECG Utilization Software (ZEUS) System is a software platform that processes and analyzes long-term continuous ECG data collected from compatible cardiac monitoring devices. It helps clinicians by automatically detecting and reporting cardiac arrhythmias and other relevant heart rhythm information, assisting in the diagnosis and management of cardiac conditions.

CINA CHEST is an AI-powered software that analyzes chest and thoraco-abdominal CT angiography scans to detect signs of pulmonary embolism and aortic dissection. It helps radiologists prioritize cases by flagging suspected positive findings through notifications, thereby improving workflow efficiency and timely patient care. The tool works alongside standard image interpretation without altering original images and is not intended for diagnosis alone but as an aid for faster triage.

Overjet Dental Assist is a software designed to assist dental professionals by semi-automatically measuring bone levels on dental bitewing and periapical radiographs. It helps by automating the measurement process to support diagnosis and treatment planning but is not intended to replace full patient evaluation or diagnosis by professionals.

The HS40 Diagnostic Ultrasound System by Samsung Medison is a versatile ultrasound imaging device designed to capture and display detailed ultrasound images using various modes such as 2D, Doppler, and 3D/4D imaging. It supports a wide range of clinical uses from obstetrics and gynecology to cardiac and musculoskeletal imaging, helping healthcare professionals diagnose conditions and analyze anatomical structures safely and effectively.

The SIGNA 7.0T is a high-performance whole-body magnetic resonance imaging (MRI) system designed to produce high-resolution images with high signal-to-noise ratio and short scan times. It supports imaging of the head and extremities in multiple planes and includes AI-driven image reconstruction software called AIR Recon DL, which enhances image quality by improving signal-to-noise ratio and sharpness without compromising low contrast detectability. This aids clinicians by providing clearer images for more accurate diagnoses.

HYPER AiR is a software device that enhances PET images by using pre-trained neural networks integrated into the image reconstruction process. It helps radiologists and nuclear medicine physicians by reducing noise and improving image contrast in fluorodeoxyglucose (FDG) PET scans, thereby potentially improving diagnostic confidence.