NEW

FDA Plans eMDR System Updates

The U.S. Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH) plans to update the FDA’s electronic medical device reporting (eMDR) system to reflect updates to the FDA Form 3500A and other system enhancements. The FDA Form 3500A is...

FDA Clears GE Healthcare’s Deep Learning-Based MR Image Reconstruction

GE Healthcare has announced U.S. FDA 510(k) clearance of AIR Recon DL. “This pioneering technology, using a deep learning-based neural network, improves the patient experience through shorter scan times while also increasing diagnostic confidence with better image...

GlobalData: Impact of COVID-19 on diagnostic imaging not as severe compared to other areas

The impact of COVID-19 on diagnostic imaging (DI) procedures will not be as severe compared to other therapy areas, such as aesthetics and dental, since only 38.7% of these procedures are elective and expected to drop due to the COVID-19 pandemic, according to...

FDA Approves Cerianna

PETNET Solutions Inc., a Siemens Healthineers company, and Zionexa USA, a wholly owned subsidiary of Zionexa SAS, have announced that the Food and Drug Administration (FDA) has approved Cerianna (fluoroestradiol F 18) injection for intravenous use. Cerianna...

Aquilion Precision Receives FDA Clearance

Canon Medical Systems USA Inc.’s newly FDA-cleared Aquilion Precision is the world’s first Ultra-High Resolution CT system (UHR CT). The system can resolve anatomy as small as 150 microns and is designed to provide more than twice the resolution, typically seen only in cath labs. Containing an all-new detector as well as tube, gantry and reconstruction technologies, the system may make it possible to help expand visualization of disease thanks to new features that offer improved image detail.

The Aquilion Precision CT system features dose efficiency with detector channels that are only 0.25 mm thick. This, combined with substantial improvements in scintillator quantum efficiency, detector circuitry and other DAS components, results in a dose-efficient detector with ultra-high resolution capabilities. The system features the industry’s smallest Focal Spot Tube at 0.4 mm x 0.5 mm and the industry’s first routine 1024 x 1024 Reconstruction Matrix.

“The increased amount of information delivered by the Aquilion Precision opens new doors for health care providers,” said Dominic Smith, senior director, CT, PET/CT, and MR Business Units, Canon Medical Systems USA. “The system delivers higher resolution images than other systems on the market, enabling customers to deliver better patient care.”

Previous

Next

Submit a Comment

Your email address will not be published. Required fields are marked *