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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...

Tools of the Trade: CS Medical TD 100 TEE Probe Disinfector

The TD 100 delivers high-level disinfection to TEE probes in 5 minutes. The TD 100 disinfects each TEE probe with high-level disinfectant and provides printed verification upon completion of a successful disinfection cycle. Microprocessor-controlled, the TD 100 is simple to use for any health care professional reprocessing a used TEE ultrasound probe. The TD 100 reduces the amount of stress and the potential for damage to TEE probes. The system was designed with every aspect of the TEE probe taken into consideration. The control handset is held securely within the TD 100, while strain and stress are minimized from the cable and electronic pack adapter with a specially designed hanger and mounts for both. Additionally, the height to insert the TEE probe distal tip and shaft is 38 inches, giving less potential of hitting and damaging the distal tip during insertion into the TD 100.

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