Stroke Detection Software Receives FDA Clearance
|
By MedImaging International staff writers Posted on 21 Feb 2018 |
|
Image: The Viz.AI Contact triage software uses an AI algorithm to analyze images for indicators associated with a stroke (Photo courtesy of Viz.ai).
The US FDA has approved a new clinical decision support software that notifies neurologists about a potential stroke in their patients by analyzing computed tomography (CT) results. The tool named Contact has been developed by Viz.ai (San Francisco, CA, USA), a direct-to-intervention healthcare company that uses artificial intelligence (AI) and deep learning algorithms to analyze medical data and improve medical workflow.
The premarket approval of the tool by the FDA was based on a retrospective study of 300 CT images that assessed the independent performance of the image analysis algorithm and notification functionality of the Viz.AI Contact application against the performance of two trained neuro-radiologists for the detection of large vessel blockages in the brain. Real-world evidence was used with a clinical study to demonstrate that the application could notify a neurovascular specialist sooner in cases where a blockage was suspected.
The Viz.AI Contact application is a computer-aided triage software that uses an AI algorithm to analyze images for indicators associated with a stroke. Designed to analyze CT images of the brain, it sends a text notification to a neurovascular specialist in case it identifies a suspected large vessel blockage. The Viz.AI Contact application automatically notifies the specialist at the same time the first-line provider is conducting a standard review of the images, allowing the specialist sooner to become involved sooner as compared to the usual standard of care wherein patients have to wait for a radiologist to review their CT images and notify a neurovascular specialist.
“Strokes can cause serious and irreversible damage to patients. The software device could benefit patients by notifying a specialist earlier thereby decreasing the time to treatment. Faster treatment may lessen the extent or progression of a stroke,” said Robert Ochs, Ph.D., acting deputy director for radiological health, Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health.
Related Links:
Viz.ai
The premarket approval of the tool by the FDA was based on a retrospective study of 300 CT images that assessed the independent performance of the image analysis algorithm and notification functionality of the Viz.AI Contact application against the performance of two trained neuro-radiologists for the detection of large vessel blockages in the brain. Real-world evidence was used with a clinical study to demonstrate that the application could notify a neurovascular specialist sooner in cases where a blockage was suspected.
The Viz.AI Contact application is a computer-aided triage software that uses an AI algorithm to analyze images for indicators associated with a stroke. Designed to analyze CT images of the brain, it sends a text notification to a neurovascular specialist in case it identifies a suspected large vessel blockage. The Viz.AI Contact application automatically notifies the specialist at the same time the first-line provider is conducting a standard review of the images, allowing the specialist sooner to become involved sooner as compared to the usual standard of care wherein patients have to wait for a radiologist to review their CT images and notify a neurovascular specialist.
“Strokes can cause serious and irreversible damage to patients. The software device could benefit patients by notifying a specialist earlier thereby decreasing the time to treatment. Faster treatment may lessen the extent or progression of a stroke,” said Robert Ochs, Ph.D., acting deputy director for radiological health, Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health.
Related Links:
Viz.ai
New
MRI Infusion Workstation
BeneFusion MRI Station
Portable X-ray Unit
AJEX140H
New
Specimen Radiography System
Trident HD
Digital X-Ray Detector Panel
Acuity G4
Latest Industry News News
- GE HealthCare and NVIDIA Collaboration to Reimagine Diagnostic Imaging
- Patient-Specific 3D-Printed Phantoms Transform CT Imaging
- Siemens and Sectra Collaborate on Enhancing Radiology Workflows
- Bracco Diagnostics and ColoWatch Partner to Expand Availability CRC Screening Tests Using Virtual Colonoscopy
- Mindray Partners with TeleRay to Streamline Ultrasound Delivery
- Philips and Medtronic Partner on Stroke Care
- Siemens and Medtronic Enter into Global Partnership for Advancing Spine Care Imaging Technologies
- RSNA 2024 Technical Exhibits to Showcase Latest Advances in Radiology
- Bracco Collaborates with Arrayus on Microbubble-Assisted Focused Ultrasound Therapy for Pancreatic Cancer
- Innovative Collaboration to Enhance Ischemic Stroke Detection and Elevate Standards in Diagnostic Imaging
- RSNA 2024 Registration Opens
- Microsoft collaborates with Leading Academic Medical Systems to Advance AI in Medical Imaging
- GE HealthCare Acquires Intelligent Ultrasound Group’s Clinical Artificial Intelligence Business
- Bayer and Rad AI Collaborate on Expanding Use of Cutting Edge AI Radiology Operational Solutions
- Polish Med-Tech Company BrainScan to Expand Extensively into Foreign Markets
- Hologic Acquires UK-Based Breast Surgical Guidance Company Endomagnetics Ltd.
Channels
Radiography
view channel
World's Largest Class Single Crystal Diamond Radiation Detector Opens New Possibilities for Diagnostic Imaging
Diamonds possess ideal physical properties for radiation detection, such as exceptional thermal and chemical stability along with a quick response time. Made of carbon with an atomic number of six, diamonds... Read more
AI-Powered Imaging Technique Shows Promise in Evaluating Patients for PCI
Percutaneous coronary intervention (PCI), also known as coronary angioplasty, is a minimally invasive procedure where small metal tubes called stents are inserted into partially blocked coronary arteries... Read more
MRI
view channel
AI Tool Tracks Effectiveness of Multiple Sclerosis Treatments Using Brain MRI Scans
Multiple sclerosis (MS) is a condition in which the immune system attacks the brain and spinal cord, leading to impairments in movement, sensation, and cognition. Magnetic Resonance Imaging (MRI) markers... Read more
Ultra-Powerful MRI Scans Enable Life-Changing Surgery in Treatment-Resistant Epileptic Patients
Approximately 360,000 individuals in the UK suffer from focal epilepsy, a condition in which seizures spread from one part of the brain. Around a third of these patients experience persistent seizures... Read more
AI-Powered MRI Technology Improves Parkinson’s Diagnoses
Current research shows that the accuracy of diagnosing Parkinson’s disease typically ranges from 55% to 78% within the first five years of assessment. This is partly due to the similarities shared by Parkinson’s... Read more
Biparametric MRI Combined with AI Enhances Detection of Clinically Significant Prostate Cancer
Artificial intelligence (AI) technologies are transforming the way medical images are analyzed, offering unprecedented capabilities in quantitatively extracting features that go beyond traditional visual... Read moreUltrasound
view channel
AI Identifies Heart Valve Disease from Common Imaging Test
Tricuspid regurgitation is a condition where the heart's tricuspid valve does not close completely during contraction, leading to backward blood flow, which can result in heart failure. A new artificial... Read more
Novel Imaging Method Enables Early Diagnosis and Treatment Monitoring of Type 2 Diabetes
Type 2 diabetes is recognized as an autoimmune inflammatory disease, where chronic inflammation leads to alterations in pancreatic islet microvasculature, a key factor in β-cell dysfunction.... Read more
Nuclear Medicine
view channel
Novel PET Imaging Approach Offers Never-Before-Seen View of Neuroinflammation
COX-2, an enzyme that plays a key role in brain inflammation, can be significantly upregulated by inflammatory stimuli and neuroexcitation. Researchers suggest that COX-2 density in the brain could serve... Read more
Novel Radiotracer Identifies Biomarker for Triple-Negative Breast Cancer
Triple-negative breast cancer (TNBC), which represents 15-20% of all breast cancer cases, is one of the most aggressive subtypes, with a five-year survival rate of about 40%. Due to its significant heterogeneity... Read more
General/Advanced Imaging
view channel
AI-Powered Imaging System Improves Lung Cancer Diagnosis
Given the need to detect lung cancer at earlier stages, there is an increasing need for a definitive diagnostic pathway for patients with suspicious pulmonary nodules. However, obtaining tissue samples... Read more
AI Model Significantly Enhances Low-Dose CT Capabilities
Lung cancer remains one of the most challenging diseases, making early diagnosis vital for effective treatment. Fortunately, advancements in artificial intelligence (AI) are revolutionizing lung cancer... Read more
Imaging IT
view channel
New Google Cloud Medical Imaging Suite Makes Imaging Healthcare Data More Accessible
Medical imaging is a critical tool used to diagnose patients, and there are billions of medical images scanned globally each year. Imaging data accounts for about 90% of all healthcare data1 and, until... Read more
