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Regulatory Compliance and Approval Processes in Medical Devices

Open Medscience

Medical Device Regulatory Compliance ensures safety and effectiveness through stringent testing and approval processes globally. The post Regulatory Compliance and Approval Processes in Medical Devices appeared first on Open MedScience.

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Ensuring Compliance: Industrial Challenges in Meeting EU MDR

Open Medscience

Ensuring compliance with EU MDR poses significant challenges for medical device manufacturers, including increased scrutiny, financial strain, and data protection demands. The post Ensuring Compliance: Industrial Challenges in Meeting EU MDR appeared first on Open MedScience.

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GE HealthCare to Spotlight Industry-Leading AI-Enabled Portfolio and Digital Solutions at HIMSS 2024

Imaging Technology

milla1cf Thu, 03/07/2024 - 20:10 March 7, 2024 — GE HealthCare will showcase its industry-leading portfolio of artificial intelligence ( AI )-enabled medical devices and digital solutions in Booth 2500 at the Health Information and Management Systems Society ( HIMSS ) Global Health Conference and Exhibition in Orlando, FL from March 11-15, 2024.

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Not All AI Is Equal: A Comparative Study of Three Imaging Algorithms

Aidoc

The adoption of artificial intelligence (AI) in medical imaging has experienced substantial growth in recent years, with more than 450 AI-based medical devices gaining approval in both Europe and the USA. Vendor B 62.8%

PACS 59
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New Version of aycan Workstation Supports Big Data

Imaging Technology

is certified under the new European MDR (Medical Device Regulation). aycan workstation is an FDA 510(k) cleared, vendor-neutral, highly functional advanced image-processing tool and DICOM PACS workstation for conventional, multi-slice, and other image reading with clinical and workflow plugins that further enhance its capabilities.

DICOM 52
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Commercial AI devices lack clinical validation, study finds

AuntMinnie

Notably, the greatest number of authorizations (392, or 75%) were for radiology devices, the authors found. We shared our findings with directors at the FDA who oversee medical device regulation, and we expect our work will inform their regulatory decision-making,” Chouffani El Fassi said.

Clinic 64
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Fujifilm’s Synapse Pathology Wins 2023 MedTech Breakthrough Award

Imaging Technology

MedTech Breakthrough is an independent market intelligence organization that recognizes the top companies, technologies and products in the global health and medical technology market. The solution was designed to seamlessly support the art of precision cancer diagnostics for pathologists.