eHealth: Viz.AI Contact App to alert for stroke in patients
Last Updated on February 15, 2018 by Joseph Gut – thasso
February 15, 2018 – The American Food and Drug Administration (FDA) just permitted marketing of the Viz.AI Contact application, a type of clinical decision support software designed to analyze computed tomography (CT) results that may notify providers of a potential stroke in their patients.
The Viz.AI Contact application is a computer-aided triage software that uses an artificial intelligence (AI) algorithm to analyze images for indicators associated with a stroke. Artificial intelligence algorithms are a type of clinical decision support software that can assist providers in identifying the most appropriate treatment plan for a patient’s disease or condition. The FDA is currently creating a regulatory framework for these products that encourages developers to create, adapt and expand the functionalities of their software to aid providers in diagnosing and treating diseases and conditions.
The Viz.AI Contact application is designed to analyze CT images of the brain and send a text notification to a neurovascular specialist if a suspected large vessel blockage has been identified. The algorithm will automatically notify the specialist during the same time the first-line provider is conducting a standard review of the images, potentially involving the specialist sooner than the usual standard of care in which patients wait for a radiologist to review CT images and notify a neurovascular specialist. The notification can be sent to a mobile device, such as a smart phone or tablet, but the specialist still needs to review the images on a clinical workstation.
The Viz.AI Contact application is intended to be used by neurovascular specialists, such as vascular neurologists, neuro-interventional specialists or other professionals with similar training. The application is limited to analysis of imaging data and should not be used as a replacement of a full patient evaluation or solely relied upon to make or confirm a diagnosis.
The company submitted 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 was reviewed through the De Novo premarket review pathway, a regulatory pathway for some new types of medical devices that are low to moderate risk and have no legally marketed predicate device to base a determination of substantial equivalence. This action also creates a new regulatory classification, which means that subsequent computer-aided triage software devices with the same medical imaging intended use may go through the FDA’s premarket notification (510 (k)) process, whereby devices can obtain marketing authorization by demonstrating substantial equivalence to a predicate device.
A stroke is a serious medical condition that requires emergency care and can cause lasting brain damage, long-term disability or even death. A stroke occurs if the flow of oxygen-rich blood to a portion of the brain is blocked, also known as an occlusion. According to the Centers for Disease Control and Prevention, stroke is the fifth leading cause of death in the United States (US) and is a major cause of serious disability for adults. About 795,000 people in the US have a stroke each year. “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 articles across the web
...October 21, 2018
Februa...February 13, 2017
...September 29, 2017
June 0...June 7, 2015
August...August 13, 2019
Excuse my blunt message, but I’m looking for websites like yours to try out our new software that is designed to help you see exactly where your site is placed in the Google search engine listings against your competitors.
You can then use the data to understand how to improve your rankings and we offer free advice too.
There is a 7 day free trial and if you can let me know what you think, that would be a great help – https://www.track-r.net
Make 16,000 Projects With Step By Step Plans… even if you don’t have a large workshop or expensive tools!
Each of the 16,000 projects are detailed enough to leave nothing to guesswork yet simple enough for beginners.
It contains complete instructions from start to finish, leaving absolutely no guesswork.
Here’s what I’m talking about == >> http://bit.ly/Largest_Woodworking_Plans