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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...

A Path to Medical Device Security

All of the information out there on cybersecurity can be overwhelming. The health care environment can be even more daunting as we’re not just talking about identity theft; we’re working with devices that touch human lives. The stakes have never been higher. The key takeaways from this discussion will be how to avoid being overwhelmed and offer several ideas on which path is the right one for your organization to take toward securing medical devices.

Jon Benedict, PMP, HCISPP, GCCC, Director of Information Security and Jump Team Operations The InterMed Group

Jon Benedict, PMP, HCISPP, GCCC, is the Director of Information Security and Jump Team Operations for The InterMed Group, in Alachua, Florida. He brings a breadth of experience to this role having worked 20+ years delivering IT and IT security assessment and remediation programs to clients in health care, energy management and the telecommunications industry. He is presently working toward his master’s degree in information security management from the SANS Technology Institute.

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