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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 SC2000 PRIME edition

Siemens Healthineers ACUSON SC2000 PRIME offers a new level of precision with up to 90°x90° unstitched real-time imaging from volume color Doppler, even in patients with arrhythmia. Engineered for versatile, reliable performance, the ACUSON SC2000 system, PRIME edition, is a complete solution for your 2D and 3D TTE, TEE, and ICE needs. What’s more, the AcuNav V is the first real-time volume ICE catheter, which supports 3D assessment of LA structures relevant to AF ablation – critically important when sizing for novel ablation and occlusion devices. •

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