FDA Radiology AI Devices

Identify (4.0) is a medical device by Varian Medical Systems designed to monitor patient motion and respiratory patterns during radiotherapy treatment simulation and delivery. Using high precision surface guided radiation therapy cameras, it helps clinicians accurately position patients and detect motion during treatment, enhancing patient safety and treatment accuracy by synchronizing imaging and radiation delivery with patient motion data.

rTOP is a teleoperation platform that allows medical professionals to remotely operate, assist, review, monitor, and standardize medical imaging and diagnostic devices. It supports video and USB interfaces for human interface devices, enabling read-only or full access control to these devices. The system facilitates remote collaboration and training across healthcare sites, helping clinicians efficiently share expertise and improve workflow, even when not physically present with the imaging equipment.

Contour ProtégéAI+ is a medical imaging software accessory that leverages machine-learning algorithms to automatically create contours of anatomical structures on CT and MR images. It supports clinicians by automating and assisting in image segmentation, which is critical for adaptive therapy, radiation treatment planning, and patient follow-up. The software provides significant time savings and improves contouring consistency, while allowing clinicians to review and edit results as needed.

TipTraQ is a wearable fingertip device designed to assist in evaluating and diagnosing sleep apnea in adults. It collects physiological data like photoplethysmogram (PPG) and movement via accelerometer, then uses cloud-based AI algorithms to analyze the data and determine critical sleep parameters such as total sleep time, REM time, and apnea-hypopnea index. This helps clinicians diagnose sleep apnea more efficiently both at home and in clinical settings.

ZeTTA PACS is a software system designed for hospitals and diagnostic centers to receive, store, retrieve, and display medical images from various modalities such as CT, MRI, ultrasound, and X-ray. It helps healthcare professionals securely access and analyze diagnostic images over hospital networks, supporting efficient image interpretation and management but does not provide diagnostic decision-making functions.

The Co-Ablation System with Sterile Co-Ablation Probe is a medical device that freezes and destroys solid tumors and abnormal tissue in various surgical fields using extreme cold temperatures. It is used in open, minimally invasive, or endoscopic procedures to treat cancers, benign tumors, skin lesions, and for pain management by freezing nerve tissue. The system works by delivering liquid nitrogen through a probe to freeze the target tissue under imaging guidance, allowing doctors to visualize the ice ball formation and control the treatment precisely for safer and more effective ablation.

The Alignment System Cranial by Brainlab AG is an image guided surgical system designed to assist neurosurgeons in planning and precisely guiding surgical instruments during cranial stereotactic procedures such as biopsy of intracranial lesions, placement of stereoelectroencephalography (SEEG) electrodes, and laser interstitial thermal therapy (LITT). It uses optical tracking technology and specialized software to continuously track instrument positions relative to patient anatomy on pre- or intraoperative images, helping clinicians achieve accurate trajectories to improve procedural safety and effectiveness.

The DigitMI 930 is a PET/CT imaging system that combines positron emission tomography and computed tomography to produce detailed images of metabolic and physiological functions in the body. It helps clinicians detect, localize, evaluate, diagnose, and monitor a wide range of conditions including cancer, cardiovascular disease, and neurological disorders by providing precise anatomical and functional imaging.

Galen™ Second Read™ is a software tool that analyzes digital images of prostate biopsy slides to identify regions suspicious for prostate cancer. It flags slides initially diagnosed as benign if it detects potential cancer areas, providing pathologists with case-level alerts and heatmaps to assist in further review. This helps improve cancer detection beyond the initial pathology review but is not intended to replace standard pathology diagnosis.

MAGENTIQ-COLO (ME-APDS) is a computer-aided detection system used alongside standard white-light colonoscopy videos to help endoscopists identify suspicious regions indicative of polyps. It processes live video frames using AI to highlight possible lesions during colonoscopy, aiming to improve detection rates and assist clinicians in real-time without replacing clinical judgement or histopathological diagnosis.