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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% Vendor B 62.8%

PACS 59
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New Version of aycan Workstation Supports Big Data

Imaging Technology

milla1cf Thu, 06/01/2023 - 20:45 June 1, 2023 — aycan , a recognized worldwide leader in medical imaging, released aycan workstation 4.00 With higher resolutions and smaller layer thicknesses, medical imaging exams are getting bigger and bigger,” said Frank Burkhardt, aycan Director, North & Latin American Operations.

DICOM 52
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Fujifilm’s Synapse Pathology Wins 2023 MedTech Breakthrough Award

Imaging Technology

Synapse Pathology – which is part of Fujifilm’s robust Synapse enterprise imaging portfolio – is a comprehensive pathology PACS solution that streamlines case management through proprietary advances in image digitization to accelerate pathology case turnaround time.

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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

I n observance of Breast Cancer Awareness Month, we wanted to get some AI insights from our partners at ScreenPoint Medical, a leading company that develops and markets image analysis and machine learning applications and services to improve early detection of breast cancer. How is AI impacting breast cancer screenings?

Medical 52
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The MQSA Final Rule 2023: What Exactly Changed and What Do I Do Next?

Mammography Educators

R)(M)(ARRT), Breast Imaging Consultant Recent headlines read: “FDA Updates Mammography Regulations in Final MQSA Rule” , “Major Updates Coming to Mammography Quality and Certification Standards….” , “FDA National Reporting Standard”, “Effective date: September 10, 2024”. This requirement DOES NOT apply to “comparison” images.