FDA Radiology AI Devices

Op.n Navigation by Ecential Robotics is a surgical navigation system designed to assist surgeons during spinal surgery. It uses intra-operative 3D imaging to help accurately position surgical instruments and implants like pedicle screws in the thoracolumbar spine. This technology improves surgical precision and patient outcomes by providing real-time navigation based on detailed imaging.

The SPINEART Navigation Instrument System is a surgical tool used in thoracolumbar spinal surgery to help surgeons accurately locate anatomical structures for the placement of spinal screws. It integrates with the eCential Op.n PERLA® TL Navigation System, which uses intraoperative 3D imaging, to improve surgical precision in both open and minimally invasive procedures.

The Intra-Operative Positioning System (IOPS®) is a surgical navigation tool that helps clinicians navigate catheters and guidewires during endovascular procedures. It uses pre-acquired 3D vascular imaging data combined with real-time electromagnetic tracking to display precise tip positioning, serving as an adjunct to fluoroscopy. This technology enhances procedural accuracy without making direct diagnoses.

The Mako Total Hip Application 5.0 is a surgical assistive system that uses CT image data to create a 3D model of a patient's hip anatomy, helping surgeons plan and perform total hip replacement surgeries with high precision. It incorporates a robotic arm and software to guide implant placement within software-defined boundaries, improving surgical accuracy and patient outcomes.

The Paradigm System is a surgical navigation device that helps surgeons accurately place spinal surgical instruments during open procedures. It integrates real-time high-resolution camera images of the surgical site with preoperative CT imagery to create a 3D model of the spine, enabling precise instrument placement and improving surgical accuracy and safety from thoracic to sacrum vertebrae.

The Primus Spinal Fixation System is a spinal fixation device designed to provide stabilization and immobilization for the thoracic, lumbar, and sacral spine regions. It includes screws, rods, and connectors that can be precisely placed with the aid of navigation instruments compatible with the Medtronic StealthStation System, which uses medical imaging data like CT and MRI scans to assist surgeons in accurate screw placement during spinal surgeries.

Materialise Personalized Guides and Models for Craniomaxillofacial Surgery is a system that combines 3D surgical planning software with patient-specific physical guides and models to assist surgeons in facial bone surgeries. It helps surgeons visualize patient anatomy, plan interventions, and accurately carry out surgeries by guiding instruments and bone cutting based on a customized surgical plan created from medical images.

ICS Dizcovery (1091) is a portable video-oculography system designed as goggles with built-in cameras and motion sensors to track eye and head movements simultaneously. It is used to assess vestibular-ocular reflex and nystagmus in patients experiencing dizziness, vertigo, or balance disorders. The system connects to software that analyzes the collected eye movement data to aid clinicians in diagnosing vestibular conditions.

The Navient Image Guide Navigation System is a computerized surgical navigation system designed to assist surgeons in precisely locating anatomical structures during neurosurgical procedures. It helps surgeons plan and navigate in real time using CT or MR images, improving accuracy and safety in cranial operations such as tumor resection and biopsies.

The Alignment System Cranial by Brainlab AG is an image guided surgical system designed to assist neurosurgeons in planning and precisely guiding surgical instruments during cranial stereotactic procedures such as biopsy of intracranial lesions, placement of stereoelectroencephalography (SEEG) electrodes, and laser interstitial thermal therapy (LITT). It uses optical tracking technology and specialized software to continuously track instrument positions relative to patient anatomy on pre- or intraoperative images, helping clinicians achieve accurate trajectories to improve procedural safety and effectiveness.