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.

NextAR Spine is an augmented reality surgical navigation platform designed to help surgeons precisely locate anatomical structures during spine surgery. It uses CT imaging and intraoperative scans to guide the placement of screws and other instruments in the thoracic and lumbosacral spine, improving surgical accuracy and patient outcomes.

CORIOGRAPH Pre-Op Planning and Modeling Services is software designed to assist surgeons with preoperative planning for orthopedic surgeries such as knee, hip, and shoulder replacements. It uses patient imaging scans to create personalized surgical plans and allows surgeons to simulate and modify implant positioning before surgery, helping improve precision and surgical outcomes.

The Navient Image Guided Navigation System (ENT) by ClaroNav is a surgical navigation tool designed to help ENT surgeons accurately locate anatomical structures by using preoperative CT and MR imaging combined with real-time optical tracking. It assists in planning and navigation during various ENT procedures, improving surgical precision and safety.

The TMINI Miniature Robotic System is a robotic surgical tool designed to assist orthopedic surgeons in accurately placing knee implant components during total knee replacement surgery. It uses preoperative CT scans to generate 3D models for surgical planning and utilizes robotic guidance during surgery to ensure precise bone preparation and implant placement, improving surgical accuracy and patient outcomes.

The VitalSigns 1-Lead Holter (VSH101) is a wireless, ambulatory ECG monitoring device that records, transmits, and stores single-channel ECG data via Bluetooth to a compatible mobile app. It helps healthcare professionals and individuals with cardiac conditions by providing supplementary ECG information for patient monitoring.

Brainlab Elements (7.0) is a suite of medical imaging software applications that aid clinicians in planning cranial and extracranial surgical and radiotherapy treatments. It provides tools for image fusion (aligning different imaging datasets), angiographic image registration, contouring (outlining anatomical structures), fibertracking (visualizing brain white matter tracts from diffusion imaging), and functional MRI mapping. The device supports precise treatment planning by combining and analyzing various imaging data, helping clinicians visualize critical anatomical and functional areas without being used for diagnostic purposes.

UroNav 4 is a medical image processing and navigation system that helps clinicians plan and guide biopsy and soft tissue ablation procedures, especially for the prostate gland. It fuses and registers 2D and 3D ultrasound images with other imaging modalities like MRI to provide real-time image guidance using electromagnetic tracking. This enhances precision in navigating interventional instruments, improving clinical outcomes in minimally invasive procedures.

The Paradigm System by Proprio, Inc. is a surgical navigation system that helps surgeons precisely position spinal instruments during posterior spine surgeries. It combines preoperative CT-based 3D models of the spine with real-time camera imaging of the surgical site to enable accurate instrument placement, improving surgical accuracy and patient outcomes.

The Anatase Spine Surgery Navigation System and Remex Spine Surgery Navigation System II are surgical navigation tools that use fluoroscopic 2D and CT 3D imaging to precisely guide the placement of surgical instruments and implants during spine surgery. By registering images intraoperatively, they help surgeons perform accurate and safe spinal implant procedures, such as lumbar pedicle screw placement, improving surgical outcomes.