FDA Radiology AI Devices

The Orthoscan VERSA Mini C-Arm is a mobile fluoroscopic X-ray system designed to provide real-time imaging for diagnostic, surgical, and emergency procedures, particularly focused on limbs, extremities, and shoulders. The system enhances clinical workflow by delivering high-quality fluoroscopic images with improved ergonomics and efficiency, helping clinicians to visualize anatomy during treatment.

ApolloHipX is a software system designed to aid surgeons during Total Hip Replacement by precisely measuring the position and alignment of hip replacement components using radiological images. It integrates pre-operative 3D patient data with intra-operative 2D X-ray images to provide near-real-time assistive measurements, helping ensure the implants are correctly positioned relative to the patient's bone structures.

Clarify DL is a software solution that uses deep learning integrated with iterative image reconstruction techniques to reduce noise and improve image quality in Nuclear Medicine bone SPECT images. It helps clinicians by enhancing image clarity which potentially improves diagnostic confidence and patient outcomes.

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 aprevo® Digital Planning software is a semi-automated surgical planning tool used by trained medical personnel. It processes 3D spine models in conjunction with clinician inputs to produce 3D models of spinal corrections and anatomical measurements, which assist surgeons in pre-operative planning for spine surgeries.

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.

MSKai is a medical software that helps clinicians by automatically identifying, measuring, and reporting features of the lumbar spine from T2 weighted MRI images. It supports radiologists and spine surgeons by providing reliable, repeatable quantitative assessments that can be reviewed and confirmed for clinical use, improving workflow efficiency.

BriefCase-Triage by Aidoc Medical, Ltd. is an artificial intelligence software that analyzes CT scans including the ribs to identify suspected acute rib fractures. It alerts clinicians with notification and preview images to help prioritize cases for faster review, aiding workflow triage without altering original images or serving as a diagnostic tool. This helps radiologists address urgent findings more efficiently.

PeekMed web is a cloud-based software system designed to assist healthcare professionals in orthopedic pre-operative planning. It works with imported imaging studies to create 2D or 3D surgical plans, supporting multiple anatomical regions including hip, knee, upper limb, and foot. It features AI-powered automatic bone segmentation and landmarking to enhance planning accuracy and efficiency, providing a comprehensive surgical overview and reports to clinicians.

The MC2 Portable X-ray System by Oxos Medical is a handheld, portable X-ray device intended to help clinicians perform point-of-care imaging of joint and bone areas (extremities) outside of surgery. It uses advanced technologies including infrared tracking and LIDAR to position and ensure safe operation, producing high-quality images in single radiography, serial radiography, and fluoroscopic modes. The device connects wirelessly to tablets or monitors for image review and facilitates efficient orthopedic imaging in various clinical settings.