One Click™ Cardiac MRI Package Receives FDA Clearance

Get Instant Instagram Followers and Likes with GetInsta

GetInsta App is 100% safe and secure to get benefits from online smart feature plans. There are lots of reliable and smart feature explorations to achieve your objectives. Learn more!

Philips Introduces Integrated Interventional Hemodynamic System with Patient Monitor IntelliVue X3

The integration provides the opportunity for monitoring during image-guided procedures on the Philips Image Guided Therapy System – Azurion, improving workflow with comprehensive patient records that support timely clinical decision-making during interventional cardiology procedures and beyond.

Lawson Health Research Institute Found Simple Device Improves Care After Kidney Transplantation

The geko™ device, manufactured by Sky Medical Technology Ltd and distributed in Canada by Trudell Healthcare Solutions Inc., is a muscle pump activator that significantly improves blood flow by stimulating the body’s ‘muscle pumps.’

HeartVista announced that it received 510(k) clearance from the U.S. Food and Drug Administration to deliver its AI-assisted One Click™ MRI acquisition software for cardiac exams. Despite the many advantages of cardiac MRI, or cardiac magnetic resonance (CMR), its use has been largely limited due to a lack of trained technologists, high costs, longer scan time, and complexity of use. With HeartVista’s solution, cardiac MRI is now simple, time-efficient, affordable, and highly consistent.

Dr. Raymond Kwong, MPH, Director of Cardiac Magnetic Resonance Imaging at Brigham and Women’s Hospital and Associate Professor of Medicine at Harvard Medical School. comments, “HeartVista’s Cardiac Package is a vital tool to enhance the consistency and productivity of cardiac magnetic resonance studies, across all levels of CMR expertise.”

A recent multi-center, outcome-based study (MR-INFORM), published in the New England Journal of Medicine, demonstrated that non-invasive myocardial perfusion cardiovascular MRI was as good as invasive FFR, the previous gold standard method, to guide treatment for patients with stable chest pain, while leading to 20% fewer catheterizations.

“This recent NEJM study further reinforces the clinical literature that cardiac MRI is the gold standard for cardiac diagnosis, even when compared against invasive alternatives,” said Itamar Kandel, CEO of HeartVista. “Our One Click™ solution makes these kinds of cardiac MRI exams practical for widespread adoption. Patients across the country now have access to the only AI-guided cardiac MRI exam, which will deliver continuous imaging via an automated process, minimize errors, and simplify scan operation. Our AI solution generates definitive, accurate and actionable real-time data for cardiologists. We believe it will elevate the standard of care for cardiac imaging, enhance patient experience and access, and improve patient outcomes.”

HeartVista’s FDA-cleared Cardiac Package uses AI-assisted software to prescribe the standard cardiac views with just one click, and in as few as 10 seconds, while the patient breathes freely. A unique artifact detection neural network is incorporated in HeartVista’s protocol to identify when the image quality is below the acceptable threshold, prompting the operator to reacquire the questioned images if desired. Inversion time is optimized with further AI assistance prior to the myocardial delayed-enhancement acquisition. A 4D flow measurement application uses a non-Cartesian, volumetric parallel imaging acquisition to generate high quality images in a fraction of the time. The Cardiac Package also provides preliminary measures of left ventricular function, including ejection fraction, left ventricular volumes, and mass.

HeartVista is presenting its new One Click™ Cardiac Package features at the Radiological Society of North America (RSNA) annual meeting in Chicago, on Dec. 4, 2019, at 2 p.m., in the AI Showcase Theater. HeartVista will also be at Booth #11137 for the duration of the conference, from Dec. 1 through Dec. 5.

spot_img

DON'T MISS

Subscribe to Medical Device News Magazine here.

Related Articles