Revolutionary AI Solution for Breast Cancer Gains Certification

Aiosyn Mitosis Breast – A Milestone in AI-Powered Diagnostics

Aiosyn, known for its innovative contributions to AI-powered pathology software, has marked an important milestone by achieving CE marking for its Aiosyn Mitosis Breast algorithm. This certification, granted under the In Vitro Diagnostic Regulation (IVDR), makes it the first application of its kind specifically for mitotic figure counting in breast cancer diagnostics. This significant achievement demonstrates Aiosyn’s commitment to enhancing clinical pathology and improving breast cancer diagnostics.

The Critical Role of Mitosis Counting

Breast cancer has emerged as the most prevalent cancer among women, with millions of new cases diagnosed each year. Despite advances in treatment and early detection, it continues to be a leading cause of cancer-related deaths worldwide. The pressing need for advanced diagnostic tools like Aiosyn Mitosis Breast is evident. By improving the precision of cancer grading, this AI-powered solution can aid in personalizing treatment strategies, which is crucial for patient outcomes.

Transforming Breast Cancer Diagnostics

“CE-IVDR certification is a pivotal development for ensuring the quality and safety of medical devices, particularly those utilizing AI technology,” remarked Wouter Bulten, Chief Operating and Product Officer at Aiosyn. The achievement of this certification not only adheres to stringent clinical and safety standards but also highlights the potential for innovation in the field of pathology. Aiosyn is dedicated to providing reliable tools that enhance diagnostic consistency and efficiency, which are essential in breast cancer care.

Enhancing Efficiency for Pathologists

The Aiosyn Mitosis Breast application employs deep learning technology to swiftly detect cell division within whole slide images. This approach not only saves valuable time for pathologists but significantly reduces subjectivity associated with traditional grading methods. Mitotic counts are essential for accurately grading tumors and making informed treatment choices. By creating standardized grading assessments, Aiosyn Mitosis Breast contributes to improved diagnostic reliability, enabling more effective patient care.

Proven Performance Through Rigorous Validation

The algorithm's effectiveness has been validated through extensive training on datasets from various pathology laboratories around the globe. A multi-center clinical performance study conducted at Radboud University Medical Center demonstrated remarkable results when pathologists employed the algorithm:

• Time savings per slide of up to 60%;
• 15% increase in overall productivity;
• 32.6% enhancement in consistency of results.

With over 90% of clinical study participants expressing interest in integrating the algorithm into their practice, Aiosyn Mitosis Breast is set to revolutionize pathology workflows.

Future Collaborations and Implementations

Patrick de Boer, CEO of Aiosyn, stated, “We are eager to collaborate with pathology laboratories to demonstrate the significant value that our solution can offer for breast cancer grading.” The application is compatible with existing digital pathology software and can be implemented in various settings, whether cloud-based or on-premises, which provides flexibility for different laboratory requirements.

About Aiosyn

Aiosyn, based in the Netherlands, specializes in developing precision pathology software tailored for breast cancer and kidney disease diagnostics. Their solutions are seamlessly integrated into standard pathology workflows, drawing on over 20 years of research expertise in the field of pathology. With a strong commitment to advancing diagnostic capabilities, Aiosyn positions itself at the forefront of pathology innovation.

Frequently Asked Questions

What is Aiosyn Mitosis Breast?

Aiosyn Mitosis Breast is an AI-powered algorithm recently certified for mitosis counting in breast cancer diagnostics.

How does this technology improve breast cancer diagnosis?

This technology enhances grading reproducibility and supports personalized treatment strategies, leading to better patient outcomes.

What benefits does the Aiosyn solution provide to pathologists?

Pathologists can save time, increase productivity, and achieve better consistency in grading with the Aiosyn Mitosis Breast application.

What makes the CE-IVDR certification significant?

The CE-IVDR certification indicates that the solution meets rigorous clinical and safety standards, setting a high benchmark for medical devices in pathology.

How can laboratories implement Aiosyn Mitosis Breast?

The application can be integrated with existing digital pathology software and can be deployed in various laboratory environments.

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