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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...

Siemens Healthineers ACUSON Sequoia

The new ACUSON Sequoia, a general imaging ultrasound system, was developed in response to one of the most prevalent challenges in ultrasound imaging today: the imaging of different sized patients with consistency and clarity. With its new Deep Abdominal Transducer (DAX), a new high-powered architecture, and innovative updates to elastography and contrast-enhanced ultrasound, the new ACUSON Sequoia produces penetration up to 40 cm. With its powerful architecture and innovative features, the new ACUSON Sequoia expands precision medicine by enabling high-resolution imaging that adapts to patients’ size and personal characteristics, contributing to more confident diagnosis.

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