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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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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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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.

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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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Breast Cancer Awareness Month: Q&A with Mark Koeniguer, CEO of ScreenPoint Medical

Aidoc

Vendor neutrality is not just for the PACS and workstations but also critical for the major 2D and 3D mammography units that are in use. It is in our daily lives, the everyday tools we use, and has been in medical devices for a long time. The AI hype is still strong, and we do not want to play in that world.

Medical 52
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Rad Perspectives: Reflecting on 2019 Healthcare AI Predictions

Aidoc

Source: Asher Orion Group on LinkedIn Since 2019, FDA support for AI devices has been tremendous. The distribution of these clearances is also interesting. Naturally, large multinational corporations like GE and Siemens lead the pack in the number of new FDA-cleared AI products.