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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...

FUJIFILM SONOSITE: SonoSite X-Porte system

FUJIFILM SonoSite Inc. develops cutting-edge ultrasound solutions and provides world-leading education to enable point-of-care visualization access to clinicians around the world. The highly portable, SonoSite X-Porte system incorporates Extreme Definition Imaging (XDI) with a user-friendly, customizable touchscreen interface that offers real-time educational visual guides and tutorials. FUJIFILM SonoSite builds durability into every ultrasound device which is why an industry-leading 5-year warranty is standard and expedited service ensures you never go without ultrasound visualization.

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