FDA Radiology AI Devices

The Precision AI Surgical Planning System (PAI-SPS) is an AI-enhanced medical device that assists surgeons in planning and performing shoulder joint replacements. It uses CT scan images to create a 3D model of the patient's shoulder, helps surgeons simulate and optimize implant positioning, and can produce custom surgical guides for use during the procedure. This system helps improve surgical accuracy and outcomes for shoulder arthroplasty patients.

TBS iNsight (V4) is a software tool that processes bone density images from DXA scans to calculate a Trabecular Bone Score (TBS). This score helps clinicians assess bone quality and fracture risk, complementing standard bone density measurements. The software improves the accuracy of evaluating osteoporosis and bone health, aiding in diagnosis and treatment monitoring.

TechCare Trauma by Milvue is an AI software that analyzes 2D X-ray images to help clinicians detect, localize, and characterize fractures and elbow joint effusions in a wide range of anatomical areas and patient populations including neonates, children, and adults. The software integrates into existing medical imaging workflows and supports clinicians by highlighting suspicious findings, improving diagnostic accuracy without replacing primary clinical decision-making.

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.

The ARVIS® Shoulder is an AI-powered computer navigation system designed for shoulder replacement surgery. It helps surgeons accurately position implants by using preoperative CT imaging and provides augmented reality visual guidance during the procedure, enhancing surgical precision and patient outcomes.

The NuVasive Pulse System is a medical device that helps surgeons precisely locate anatomical structures during spinal surgeries using intraoperative 3D imaging and computer-assisted navigation. It tracks surgical instruments in real-time and overlays their virtual positions on patient images, enhancing surgical accuracy and safety in procedures like pedicle screw placement and iliosacral screw placement.

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.

The TMINI Miniature Robotic System is a robotic-assisted surgical device designed to help surgeons accurately plan and execute total knee replacement surgeries. It uses preoperative CT scans to create 3D bone models, allowing precise implant positioning through software planning and robotic guidance. The system enhances surgical accuracy and efficiency by using AI-enhanced image segmentation, intraoperative tracking, and spatial boundary definition during surgery.

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.