272 matching use cases
Health and Medical ×
OMB-IND-VA-24-4472OMB Individually Reported

Identify access to genetic testing in Veterans with breast cancer.

Try to identify which Veteran with breast cancer has or does not have access to germline genetic testing from unstructured medical notes.

OMB Individually ReportedHealth and MedicalLow risk
OMB-IND-VA-24-4513OMB Individually Reported

Clinical Pathways for Cancer Patients

The VA National Oncology Program (NOP) has invested in creating clinical pathways that guide providers to provide high quality evidence-based standard of care treatments to Vetera…

OMB Individually ReportedHealth and MedicalLow risk
OMB-IND-VA-24-4554OMB Individually Reported

Extract patients’ diagnosis information and map the diagnosis to oncotree

Extract patient diagnosis from unstructured patient notes and map the diagnosis to oncotree, because these information typically is extracted manually and it takes a long time to…

OMB Individually ReportedHealth and MedicalHigh risk
OMB-IND-VA-24-4566OMB Individually Reported

QLAB Advanced Quantification Software

The Philips QLAB Advanced Quantification Software System (QLAB) is designed to view and quantify image data acquired on Philips ultrasound systems. QLAB is available either as a s…

OMB Individually ReportedHealth and MedicalHigh risk
OMB-IND-VA-24-4595OMB Individually Reported

Cancer Patients Symptom Burden

Attempt to extract patients' symptom burden information from unstructured notes to increase the speed of providers identifying patients that may benefit from additional support fo…

OMB Individually ReportedHealth and MedicalHigh risk
OMB-IND-VA-24-4599OMB Individually Reported

Preventice BodyGuardian Remote Monitoring System

The BodyGuardian System detects and monitors cardiac arrhythmias in ambulatory patients, when prescribed by a physician or other qualified healthcare professional.

OMB Individually ReportedHealth and MedicalHigh risk
OMB-IND-VA-24-4607OMB Individually Reported

EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System

The R-Trigger algorithm software feature on Philips EPIQ and Affiniti Ultrasound System is intended to support detection of R-wave peak (R-trigger) as an input to certain transtho…

OMB Individually ReportedHealth and MedicalHigh risk
OMB-IND-VA-24-4640OMB Individually Reported

Glassbeam Clinsights

The system medical device data and then uses AI to predict medical device failure. So it uses wear and tear data to determine if the components are failing to prevent patient harm.

OMB Individually ReportedHealth and MedicalLow risk
OMB-IND-VA-24-4648OMB Individually Reported

Persyst 14 EEG Review and Analysis Software

Automatic electroencephalogram (EEG) measurement and seizure detection: Persyst 14 EEG Review and Analysis Software is intended for the review, monitoring and analysis of EEG reco…

OMB Individually ReportedHealth and MedicalHigh risk
OMB-IND-VA-24-4689OMB Individually Reported

OPTIS Mobile Next Imaging System, OPTIS Integrated Next Imaging System

With the Ultreon 1.0 software application, these systems perform Optical Coherence Tomography (OCT) imaging of coronary arteries using compatible Dragonfly imaging catheters. Res…

OMB Individually ReportedHealth and MedicalHigh risk
OMB-IND-VA-24-4730OMB Individually Reported

O-arm O2 Imaging System

The O-arm O2 Imaging System is a mobile X-ray system designed for 2D and 3D imaging for adult and pediatric patients weighing 60lbs or greater and have an abdominal thickness grea…

OMB Individually ReportedHealth and MedicalHigh risk
OMB-IND-VA-24-4771OMB Individually Reported

NeuroQuant

NeuroQuant is a medical device with a fully automated Magnetic resonance (MR) imaging post-processing software that provides automatic labeling, visualization, and volumetric quan…

OMB Individually ReportedHealth and MedicalHigh risk
OMB-IND-VA-24-4812OMB Individually Reported

MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Aera; MAGNETOM Skyra; MAGNETOM Prisma; MAGNETOM Prisma fit

The MAGNETOM system is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross-sectional images, spectrosc…

OMB Individually ReportedHealth and MedicalHigh risk
OMB-IND-VA-24-4923OMB Individually Reported

3D Quorum

Identifies clinically relevant regions of interest through overlapping slices (3mm) to ensure no loss of 3D data. Reduces the number of 3D images to be reviewed by the Radiologist…

OMB Individually ReportedHealth and MedicalHigh risk
OMB-IND-VA-24-4935OMB Individually Reported

TeraRecon iNtuition-Structural Heart Module

The iNtuition-Structural Heart Module is an iNtuition (K121916) based optional feature that employs all standard features offered by iNtuition. These standard features include con…

OMB Individually ReportedHealth and MedicalHigh risk
OMB-IND-VA-24-5005OMB Individually Reported

QVCAD System

QVCAD is designed to process and display a projection image, using the ABUS image stack on a customer supplied computer, and monitor it for review, with certain areas highlighted…

OMB Individually ReportedHealth and MedicalHigh risk
OMB-IND-VA-24-5017OMB Individually Reported

FFRangio

FFRangio analysis is intended to support the functional evaluation of coronary artery disease. The results of this analysis are provided as a supportive aid for qualified clinicia…

OMB Individually ReportedHealth and MedicalHigh risk
OMB-IND-VA-24-5046OMB Individually Reported

Quantra

The Quantra software is designed to estimate breast composition categories by analyzing the distribution and texture of parenchymal tissue patterns, which can be responsible for t…

OMB Individually ReportedHealth and MedicalHigh risk
OMB-IND-VA-24-5054OMB Individually Reported

Surveillance and Reporting of Suicidal Ideation Assessment in PTSD Specialty Care Clinical Notes using Natural Language Processing (NLP)

In light of the known elevated suicide risk among individuals diagnosed and in treatment for mental health conditions, and the associated need for ongoing monitoring of suicidalit…

OMB Individually ReportedHealth and MedicalLow risk
OMB-IND-VA-24-5058OMB Individually Reported

FastStroke, CT Perfusion 4D

CT perfusion 4D is an image analysis software package, which allows the user to produce dynamic image data and generate information with regards to changes in image intensity over…

OMB Individually ReportedHealth and MedicalHigh risk
OMB-IND-VA-24-5087OMB Individually Reported

Koios

FDA Cleared. Used with Automated Breast Ultrasound (ABUS). Classifies breast ultrasound lesions and automates reporting for improved efficiency and streamlined workflows. Increase…

OMB Individually ReportedHealth and MedicalHigh risk
OMB-IND-VA-24-5140OMB Individually Reported

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…

OMB Individually ReportedHealth and MedicalHigh risk
OMB-IND-VA-24-5169OMB Individually Reported

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…

OMB Individually ReportedHealth and MedicalHigh risk
OMB-IND-VA-24-5222OMB Individually Reported

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…

OMB Individually ReportedHealth and MedicalHigh risk