Technology | Computed Tomography (CT) | July 12, 2018

Zebra Medical Vision Announces FDA 510(k) Clearance of Coronary Calcium Algorithm

Zebra’s algorithm automatically calculates coronary calcium score from ECG-gated CT scans, providing physicians an important tool to assess the risk of cardiovascular events

Zebra Medical Vision Announces FDA 510(k) Clearance of Coronary Calcium Algorithm

July 12, 2018 — Zebra Medical Vision has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Coronary Calcium Scoring algorithm. The algorithm, capable of automatically calculating a patient’s Agatston equivalent coronary calcium score from an electrocardiogram (ECG)-gated computed tomography (CT) scan, provides physicians with important data used in the assessment of the risk for coronary artery disease.

Coronary artery disease (CAD) is a major cause of death in developed countries. It remains responsible for approximately one-third of all deaths of individuals aged over 35 years old. According to estimates, nearly one-half of men and one-third of women over 40 years old will develop some symptoms of CAD in the United States. Numerous studies have shown that early detection and treatment of CAD can reduce the incidence of heart attacks in at-risk populations. Studies have also shown that coronary artery calcium score is useful for risk stratification of patients.

“Identification of high-risk individuals is key to prevention,” said Prof. Ran Balicer, director of the Clalit Research Institute. Clalit is the largest integrated healthcare payer/provider system in Israel, caring for over 4 million people. “Zebra’s algorithm could run on CT studies of the chest and potentially help identify people with cardiovascular risk sooner, allowing more effective treatment and overall reduction of adverse outcomes and healthcare costs for HMOs such as Clalit.”

The coronary calcium algorithm is the first Zebra algorithm to achieve U.S. approval. The company has had seven algorithms achieve CE mark in Europe.

For more information: www.zebra-med.com

Related Content

Osprey Medical and GE Healthcare Launch Acute Kidney Injury Educational Program
News | Angiography | September 25, 2018
September 21, 2018 — Osprey Medical announced a collaboration with GE Healthcare on Osprey’s Be Kind to Kidneys campa
Philips Showcases Integrated Solutions for Cardiovascular Care at TCT 2018
News | Cardiac Imaging | September 20, 2018
At the Transcatheter Cardiovascular Therapeutics (TCT) annual meeting, Sept. 21–25 in San Diego, Philips is showcasing...
LVivo EF Cardiac Tool Now Available for GE Vscan Extend Handheld Mobile Ultrasound
Technology | Cardiovascular Ultrasound | September 19, 2018
DiA Imaging Analysis Ltd. (DiA), a provider of artificial intelligence (AI)-powered ultrasound analysis tools,...
SimonMed Deploys ClearRead CT Enterprise Wide
News | Computer-Aided Detection Software | September 17, 2018
September 17, 2018 — National outpatient physician radiology group SimonMed Imaging has selected Riverain Technologie
Siemens Healthineers Announces First U.S. Install of Somatom go.Top CT
News | Computed Tomography (CT) | September 17, 2018
September 17, 2018 — The Ohio State University Wexner Medical Center in Columbus recently became the first healthcare
The Siemens Biograph Vision PET-CT system was released in mid-2018.

The Siemens Biograph Vision PET-CT system was released in mid-2018.

Feature | Nuclear Imaging | September 07, 2018 | By Dave Fornell
Nuclear imaging technology for both single photon emission computed tomography (SPECT) and positron emission tomography...
The CT scanner might not come with protocols that are adequate for each hospital situation, so at Phoenix Children’s Hospital they designed their own protocols, said Dianna Bardo, M.D., director of body MR and co-director of the 3D Innovation Lab at Phoenix Children’s.

The CT scanner might not come with protocols that are adequate for each hospital situation, so at Phoenix Children’s Hospital they designed their own protocols, said Dianna Bardo, M.D., director of body MR and co-director of the 3D Innovation Lab at Phoenix Children’s.

Sponsored Content | Case Study | Radiation Dose Management | September 07, 2018
Radiation dose management is central to child patient safety. Medical imaging plays an increasing role in the accurate...
Carestream Releases Second-Generation Metal Artifact Reduction Software for OnSight 3D Extremity System
Technology | Computed Tomography (CT) | September 06, 2018
Carestream Health has started shipping a new software version for its Carestream OnSight 3D Extremity System that...

Image courtesy of Siemens Healthineers

Feature | CT Angiography (CTA) | September 06, 2018 | Dave Fornell
There have been a few big, recent advancements in cardiac computed tomography angiography (CCTA) imaging technology....
Key Patient Preparations for a CT Scan
News | Computed Tomography (CT) | September 05, 2018
The Center for Diagnostic Imaging (CDI) in Miami recently released a list of important preparations patients should...