Koios
FDA Cleared. Used with Automated Breast Ultrasound (ABUS). Classifies breast ultrasound lesions and automates reporting for improved efficiency and streamlined workflows. Increase…
Discovery MI Gen2
The Discovery MI Gen2 PET/CT system is intended for CT attenuation corrected, anatomically localized PET imaging of the distribution of positron-emitting radiopharmaceuticals. It…
Genius AI
Genius AI Detection is a computer-aided detection and diagnosis (CADe/CADx) software device. It is intended to be used with compatible digital breast tomosynthesis (DBT) systems t…
CT CoPilot
CT CoPilot is intended for use in automating post-acquisition quantitative analysis of computed tomography (CT) images of the brain for patients aged 18 or older. CT CoPilot perfo…
Cranial Navigation, Navigation Software Cranial, Navigation Software Craniofacial, Cranial EM System, Automatic Registration iMRI
Cranial EM is intended as an image-guided planning and navigation system to enable neurosurgery procedures. The device is indicated for any medical condition in which a reference…
CellaVision DM1200 with the body fluid application
CellaVision DM 1200 with the body fluid application automatically locates and presents images of nucleated cells on cytocentrifuged body fluid preparations. The body fluid applica…
Nediser Reports QA
Nediser is a continuously trained artificial intelligence "radiology resident" that assists radiologists in confirming features in radiology images, including x-ray. It helps with…
CARTO 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U)
The CARTO 3 EP Navigation System V8.0, is a catheter-based atrial and ventricular mapping system designed to acquire and analyze navigation catheter’s location and intracardiac EC…
Care Assessment Needs (CAN) Score
Identify patients at potential risk for 90 day hospitalization and 90 day mortality: CAN 3.0 is a pair of logistic regression models that risk stratify Veterans by their likelihoo…
Cartesion Prime (PCD-1000A/3) V10.15
The system is intended to acquire PET images of any desired region in the whole body and CT images of the same region (used for attenuation correction or image fusion) to detect t…
VA CART SYNTAX Risk Model
The VA CART SYNTAX risk model predicts 30-day post-Percutaneous Coronary Intervention (PCI) mortality, using a combination of clinical and anatomic variables. The model is availab…
Fall Prediction Tool
The Morse Fall Scale (MFS), as it is currently utilized, often fails to accurately assess fall risk, highlighting the need for more precise and timely fall risk assessment tools t…
VA CART Mortality Model
The VA CART mortality risk model is based on logistic regression using baseline clinical and procedural variables to predict post-PCI 30-day mortality. The model is available to f…
VA CART Nephropathy Risk Model
The VA CART nephropathy risk model is based on logistic regression using baseline clinical and procedural variables to predict Post-Percutaneous Coronary Intervention (PCI) acute…
Brainlab Elements Image Fusion, Contouring (4.5);Image Fusion (4.5);Fibertracking (2.0);BOLD MRI Mapping (1.0);Image Fusion Angio (1.0)
Brainlab Elements are software applications indicated for the processing of medical image data to support the intended user group to perform image guided surgery and radiation tre…
BioPlex 2200 ANA Screen with Medical Decision Support Software for Use with BioPlex 2200 Multi-Analyte Detection System
The BioPlex 2200 Medical Decision Support Software (MDSS) is a pattern recognition algorithm that can enhance the performance of the Antinuclear Antibody (ANA) Screening associate…
VA CART Bleeding Risk Model
The VA CART bleeding risk model is based on logistic regression, using baseline clinical and procedural variables to predict post-Percutaneous Coronary Intervention (PCI) in-hospi…
Biograph Vision, Biograph MCT Family Of PET/CTs
The Biograph Vision and Biograph mCT systems provide registration and fusion of high-resolution metabolic and anatomic information from the two major components of each system (Po…
AutoContour Model RADAC V3
AutoContour is intended to assist radiation treatment planners in contouring and reviewing structures within medical images in preparation for radiation therapy treatment planning.
Aplio i900, Aplio i800 and Aplio i700 Software V8.1 Diagnostic Ultrasound System
The Diagnostic Ultrasound System Aplio i900 Model TUS-AI900, Aplio i800 Model TUS-AI800, Aplio i700 Model TUS-AI700 are indicated for the visualization of structures and dynamic p…
Alignment System Cranial, Alignment Software Cranial, Cirq Alignment Software Cranial Biopsy, Cirq Alignment Software Cranial sEEG, Varioguide Alignment Software Cranial
Alignment System Cranial is intended to support the surgeon in planning and achieving a trajectory with surgical instruments during cranial stereotactic procedures. The indication…
Acumen Hypotension Prediction Index - EV1000 Clinical Platform, Acumen Hypotension Prediction Index - Hemosphere Advanced Monitoring Platform, Acumen Hypotension Prediction Index, Hemosphere Advanced Monitoring Platform - Pressure
The Edwards Lifesciences Acumen Hypotension Prediction Index feature provides the clinician with physiological insight into a patient’s likelihood of future hypotensive events (de…
Abridge Ambient Scribe
This solution is intended to solve the following problems: - Clinician burnout by decreasing clinical documentation burden which is resulting in - Clinicians focusing on their c…
Healthcare Text Anonymizer
This application reduces the manual processing time for anonymization and improves the accuracy of removing identifiable information in healthcare text. This is important because…