FDA Radiology AI Devices

The ROSA Knee System is a robotic-assisted surgical device used during total knee replacement surgeries. It helps surgeons precisely place knee implants by using software to define spatial boundaries relative to anatomical landmarks and utilizing a robotic arm to guide bone resections and implant positioning. This system can integrate pre-operative imaging such as X-rays or MRI to plan surgeries more accurately and improve surgical outcomes.

BriefCase-Triage is an AI-powered software designed to analyze CT scans of the cervical spine in adults, helping hospital networks and medical specialists by flagging potential fractures. It provides notifications and preview images of suspected cases, enabling faster prioritization of urgent findings to improve clinical workflow and patient care, while not altering original diagnostic images.

The Blueprint Patient-Specific Instrumentation system by Stryker Corporation includes hardware and software components designed to assist surgeons in planning and performing shoulder replacement surgeries, specifically reversed shoulder arthroplasty. It uses CT scans to generate patient-specific surgical guides and implants, improving the precision of implant placement and potentially leading to better surgical outcomes for patients with shoulder joint conditions.

The SpineUs™ System by Verdure Imaging is a diagnostic ultrasound platform designed to help trained chiropractors and radiologists acquire, view, segment, and measure spinal ultrasound images. It uses AI technology to automatically segment vertebral bone structures and provides 3D reconstructions and quantitative measurements such as intervertebral angles and spine curvature, aiding clinical evaluation of the spine in both hospital and clinic settings.

QUADSENSE is a surgical tool used during total knee replacement surgery to help surgeons measure and compare the forces in the patellofemoral joint before and after patella resurfacing. The device includes a sensor attached to the patella and displays real-time force data to support surgical decision-making, improving joint alignment and implant positioning.

MuscleView is an AI-powered software that automatically segments muscles and bones in MRI scans of the lower limbs. It calculates useful metrics such as muscle and bone volume, fat infiltration, and asymmetry to assist physicians in analyzing musculoskeletal health. The segmentations need to be reviewed and edited by trained clinicians. This tool helps improve the efficiency and accuracy of muscle and bone analysis from MRI images but is not intended for diagnostic use of diseases.

CINA-CSpine by Avicenna.AI is a radiological computer-assisted triage and notification software that uses AI algorithms to analyze cervical spine CT scans for suspected acute fractures. It helps hospital networks and trained physicians by flagging potential fracture cases and prioritizing image review, enabling faster and more efficient diagnosis and patient care. It operates alongside the standard care workflow without altering original images, providing notifications with preview images for informational purposes.

CoLumbo is a software tool that helps radiologists and spine surgeons analyze MRI images of the lumbar spine by automatically segmenting anatomical features and measuring spine structures. It identifies out-of-range measurements and assists users in documenting findings, streamlining the review and reporting process without making any medical diagnosis.

The Precision AI Surgical Planning System (PAI-SPS) is a software and hardware system designed to assist surgeons in preoperative planning and intraoperative guidance for shoulder replacement surgeries. It creates a 3D model of the patient's shoulder joint from CT scans, allowing surgeons to visualize and plan implant placement precisely. Custom surgical guides are also produced to help accurately position shoulder implant components during surgery, enhancing surgical outcomes.

Rayvolve by AZmed SAS is an AI-powered software designed to assist radiologists and emergency physicians in detecting fractures from X-ray images of various musculoskeletal regions in adults and children aged 2 years and older. It enhances fracture diagnosis by automatically highlighting potential fractures on standard radiographic views, improving diagnostic accuracy and workflow efficiency.