FDA Radiology AI Devices

The InsightersTM Single-use Bronchoscope System is a medical imaging device consisting of disposable flexible bronchoscopes and a compatible workstation display. It provides clear, real-time images for clinicians to observe, diagnose, and treat diseases affecting the trachea, bronchi, and lungs. The device enhances clinical workflow with its portability, image clarity, and single-use design to reduce risk of infection.

The OptiMap™ System is a medical device used during electrophysiology procedures to help physicians analyze and visualize complex cardiac arrhythmias. It uses a 64-electrode basket catheter to capture electrogram signals within the heart, which are processed with proprietary algorithms to create detailed maps of electrical flow and activation pathways. This assists clinicians in diagnosing and understanding heart rhythm disorders more effectively.

Rapid MLS is an AI-powered software that analyzes non-contrast CT scans to measure and visually display brain midline shifts. This helps clinicians assess conditions like intracranial hemorrhage and traumatic brain injury by providing quantitative and annotated images, supporting but not replacing clinical decision-making.

TAIMedImg DeepMets is a software tool that uses artificial intelligence to assist medical professionals by automatically outlining brain metastases on MRI scans. This helps speed up the workflow for planning radiation therapy treatment in patients with diagnosed brain metastases, ensuring accurate contours that clinicians can verify and adjust as needed.

DeepRhythmAI is a cloud-based AI software that automatically analyzes ECG data from one or two leads to detect cardiac arrhythmias. It supports integration with various ECG recording devices and systems, providing clinicians with supportive analysis to aid in diagnosis, improving cardiac rhythm assessment accessibility and efficiency.

Clever One is dental imaging software designed to acquire, process, view, and analyze 2D and 3D medical images from dental CT, panoramic, cephalometric, and intraoral imaging devices. It helps clinicians by providing advanced visualization and analytic tools such as bone density analysis, implant planning, and multi-planar reconstructions, facilitating more accurate diagnostics and treatment plans.

Accuro 3S is a portable diagnostic ultrasound imaging system designed for use by trained healthcare professionals in hospitals or clinics. It provides B-mode ultrasound imaging with an advanced AI-based software called SpineNav-AI that assists with musculoskeletal imaging of the lumbar spine, especially guiding neuraxial anesthesia procedures. This system enhances clinicians' ability to accurately visualize anatomical structures and guide needle placements safely and efficiently.

The Stereotaxic Guiding Surgical Device, NaoTrac S, is a robotic system designed to assist neurosurgeons in accurately positioning and guiding surgical instruments during stereotactic neurosurgical procedures. By using preoperative MRI or CT images for planning and intraoperative guidance, it helps surgeons precisely target brain regions for biopsies, electrode placement, or other interventions, improving surgical accuracy and patient safety.

The RadiForce MX317W-PA is a color LCD monitor designed for displaying digital images of histopathology slides acquired from whole-slide imaging scanners. It aids pathologists in the review and interpretation of these slides for primary diagnosis by providing high-quality image visualization with calibrated display modes and color accuracy.

NeuroMatch is a cloud-based software that assists neurologists by reviewing and analyzing EEG recordings to detect seizures and spikes, reduce artifacts, and visualize brain electrical activity through 3D source localization on an idealized head model. It helps clinicians understand brain activity over time by displaying quantitative trends, improving EEG assessment without providing diagnostic conclusions.