FDA Radiology AI Devices

VEA Align; spineEOS by EOS imaging is an AI-based software designed to automatically process radiological images of the spine. It helps clinicians by aligning and analyzing spinal images, improving accuracy and efficiency in diagnosing and treatment planning for spinal conditions.

TraumaCad Neo (1.1) is software that helps surgeons plan and evaluate orthopedic procedures by using X-ray images. It overlays measurements and prosthesis templates to assist in surgical planning and postoperative assessment, including automated analysis of hip arthroplasty outcomes using AI. This streamlines workflow and supports clinical decisions prior to and after surgery.

AudaxCeph Cephalogram Analysis Software is a specialized software intended for dental professionals to assist in treatment planning by analyzing 2D cephalogram images. It automatically detects landmarks on images, allows measurement and superimposition, and supports orthodontic treatment planning. The software can be used as a desktop application or via the cloud, helping clinicians make informed decisions by digitizing and analyzing dental radiological images efficiently.

CoLumboX is a software tool that helps healthcare professionals analyze lumbar spine x-ray images by automatically segmenting and measuring spine features. It provides quantitative information and highlights out-of-range measurements to assist in clinical evaluations, supporting more efficient and accurate patient assessments without making diagnoses itself.

Second Opinion BLE is a software tool that uses AI to help dental professionals measure bone levels in bitewing and periapical radiographs. It assists clinicians by automatically detecting and displaying bone level measurements to aid in patient assessment, but it is not intended to replace full clinical evaluation.

BoneMetrics (US) is an AI-powered software that automatically measures Cobb angles on frontal spine x-rays to assist healthcare professionals in evaluating spinal deformities such as scoliosis. It integrates with existing imaging systems to provide quantitative angle measurements that can support clinical decision-making, improving workflow efficiency and consistency.

Ortho AI is a medical software device that helps orthopedic surgeons by using AI to semi-automatically measure lengths, angles, and implant positions on radiographic images. It assists in preoperative and intraoperative planning for hip, knee, and lumbar spine surgeries through digital annotations and measurements, improving surgical planning accuracy and efficiency.

The OrthoNext Platform System is a web-based software that helps healthcare professionals plan orthopedic surgeries and treatments by overlaying product templates on X-ray images and providing measurement and simulation tools. It assists in both preoperative and postoperative planning, enabling clinicians to make informed decisions by digitally visualizing and measuring treatment options.

Overjet Image Enhancement Assist is a software tool that improves the quality of dental x-ray images such as bitewing, periapical, and panoramic images. It uses AI algorithms to reduce noise and enhance contrast and sharpness, helping dental professionals see clearer images for better diagnosis. The software operates within the Overjet device platform and is intended to be an optional enhancement tool, not a replacement for existing imaging systems.

The Overjet Charting Assist is a software system that helps dental professionals analyze 2D dental X-rays by detecting natural dental structures like tooth anatomy and numbering, as well as restorative dental work such as crowns and implants. It supports clinicians by automating dental chart creation from images, aiding in more precise and efficient dental assessments.