FDA Radiology AI Devices

SpineAR SNAP is a software device that helps surgeons plan and perform spinal implant surgeries more accurately by transforming traditional 2D medical images into interactive 3D visualizations. It supports pre-operative planning on screens and virtual reality, as well as intra-operative guidance using augmented reality headsets like HoloLens2 and Magic Leap 1. This technology provides enhanced visualization and guidance, improving surgical precision while allowing the surgeon to maintain focus on the surgical field.

PanopticAI Vital Signs is a medical software application that uses AI algorithms to measure pulse rate non-invasively by analyzing color changes in facial video captured from an iPhone or iPad camera. It helps healthcare professionals monitor a patient's pulse rate remotely, providing a convenient tool to complement traditional vital sign assessments.

Noxturnal Web is a web-based software designed to display, analyze, and manually score pre-recorded physiological data collected during sleep studies. It assists clinicians in diagnosing sleep and respiratory-related disorders by enabling detailed review and reporting of sleep stages and breathing events such as obstructive apneas, all under clinical supervision.

Lightning Viewer is a web-based medical image viewing software that allows healthcare professionals to review, manipulate, and annotate diagnostic images from various modalities. It supports major desktop browsers, offers advanced visualization tools like 3D MPR and MIP, and integrates with PACS systems to facilitate efficient radiology workflows and aid clinicians in making diagnostic decisions.

The aprevo® Digital Planning software is a semi-automated surgical planning tool used by trained medical personnel. It processes 3D spine models in conjunction with clinician inputs to produce 3D models of spinal corrections and anatomical measurements, which assist surgeons in pre-operative planning for spine surgeries.

The Cardiac Workstation 5000 and 7000 by Philips Medizin Systeme Böblingen GmbH are advanced electrocardiograph devices designed for healthcare professionals to acquire, analyze, and store multi-channel ECG signals from adult and pediatric patients. These devices use clinically proven algorithms to provide measurements, graphical presentations, and interpretive statements to support clinical decision-making in hospitals and cardiology clinics.

Roche Digital Pathology Dx is a digital slide scanning and management system designed to assist pathologists by creating, viewing, and managing high-resolution digital images of pathology slides prepared from formalin-fixed paraffin-embedded tissue. It includes slide scanners and software for image acquisition and management, enabling pathologists to review digital slides instead of traditional light microscopy.

Sim&Size is a medical imaging software designed to help clinicians visualize cerebral blood vessels and simulate the placement and sizing of neurovascular implantable devices for preoperative planning. It uses 3D images from rotational angiography to provide 3D reconstructions, automatic vessel segmentation, and tools for sizing and positioning implantable devices, supporting better planning of neurovascular interventions and surgeries.

Mac-Lab (AltiX AI.i), CardioLab (AltiX AI.i), ComboLab (AltiX AI.i), and MLCL Client Software (AltiX AI.i) are hemodynamic and electrophysiology recording systems developed by GE Healthcare. These systems record and display physiological data during cardiovascular procedures, allowing clinicians to analyze hemodynamic and electrophysiology signals in real time. The MLCL Client Software allows additional data analysis and remote viewing. These tools help doctors monitor and analyze patients' cardiovascular function during interventional procedures.

The Infrascanner Model 2500 is a noninvasive medical device designed to help detect traumatic brain hematomas in patients with head injuries. It uses near-infrared light to measure differences in hemoglobin concentration in the brain, which indicate the presence of hematomas. The device aids clinicians in quickly assessing patients for further CT scans, improving early diagnosis and treatment in hospital settings.