Mindpeak Earns IVDR Certification, Reinforcing Its Commitment to Quality and Regulatory Excellence

September 11, 2026

Certification under the EU's In Vitro Diagnostic Regulation validates Mindpeak's quality management system, confirming it meets the EU's most rigorous standard for cancer-related diagnostic devices - a milestone for the Hamburg-based AI diagnostics company as it deepens partnerships across Europe.

HAMBURG, Germany – SEPTEMBER 11, 2026 – Mindpeak, a leading developer of AI-powered software for digital pathology, today announced it has achieved certification under the EU In Vitro Diagnostic Medical Devices Regulation (IVDR). The certification, issued following rigorous assessment by BSI, a leading EU Notified Body, confirms that Mindpeak's quality management system meets the EU's most demanding regulatory standard for diagnostic software.

Setting a New Standard for AI-Powered Diagnostics

IVDR is widely regarded as one of the most demanding regulatory frameworks in the medical device world, requiring manufacturers to demonstrate robust, auditable quality processes across the full device lifecycle — from design and development through manufacturing, distribution, and post-market surveillance. Achieving this certification places Mindpeak's organizational infrastructure on the same regulatory footing required of every IVD device placed on the EU market.

"Achieving IVDR certification is a defining milestone for Mindpeak - it's proof that our technology doesn't just perform in the lab, it meets the same standard that governs every diagnostic device used in patient care across Europe. This is the foundation we'll build the next phase of our platform on." said Felix Faber, CEO and Founder of Mindpeak.

Built for Scale, Built for Trust

Mindpeak's certified quality management system meets the requirements of ISO 13485 and IVDR Annex IX, as confirmed by BSI Group - a reflection of the standards Mindpeak holds itself to as it builds AI diagnostics for high-stakes clinical use. This milestone reflects the maturity of Mindpeak's regulatory infrastructure as it continues to expand its footprint with laboratories and diagnostic partners across Europe.

By meeting IVDR requirements, Mindpeak reinforces its commitment to delivering AI-powered pathology tools that pathologists and laboratories can trust for high-stakes clinical decision-making - further solidifying the company's position at the forefront of AI-driven precision diagnostics.

About Mindpeak

Mindpeak is the leading company in AI-powered digital pathology, bridging the gap from biomarker development to clinical diagnostics. Founded in 2018, Mindpeak's AI technology enables laboratories to extract actionable insights from IHC, H&E, and mIF tissue images - ranging from subcellular biomarker quantification to predictive patient stratification. The solutions support both routine diagnostics as well as the discovery and translation of novel biomarkers into real-world clinical applications.

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Mindpeak Welcomes Christiaan Neeleman to the Board of Directors

We are delighted to announce that Christiaan Neeleman has joined Mindpeak’s Board of Directors.

With more than 20 years of international leadership experience in life sciences, diagnostics, and health technology - including senior roles at Discovery Life Sciences, Definiens, and Philips Healthcare - Christiaan brings deep expertise that will help accelerate our global expansion.

His proven track record in biomarker development, companion diagnostics, and scaling precision diagnostics businesses aligns perfectly with Mindpeak’s mission: enabling faster, more accurate cancer diagnostics through AI-powered pathology.

We are excited to collaborate with Christiaan as we strengthen partnerships, expand into new markets, and further drive the adoption of AI across clinical and research settings.

Read the full press release here

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Expanding Global Access to AI Diagnostics – Our New Partnership with Pathomation

At Mindpeak, our vision is clear: world-class AI diagnostics should be available to every pathology lab, everywhere. By partnering with leading technology providers, we’re removing barriers to adoption and making AI-powered precision diagnostics a practical reality for labs worldwide.

Seamless AI Integration with Pathomation

Through our strategic collaboration with Pathomation, a globally trusted provider of digital pathology platforms, Mindpeak’s CE-IVD certified AI algorithms – including Ki-67, HER2, and zero-click PD-L1 scoring across multiple tissue types – are now natively integrated into Pathomation’s solutions.

This partnership means laboratories can:

Adopt advanced AI instantly – No extra development, integrations, or technical overhead required.
Work within existing workflows – Our algorithms run directly inside Pathomation’s widely adopted platform.
Deliver faster, more consistent results – Helping pathologists make confident, high-quality diagnostic decisions for patients everywhere.

Reaching More Labs, Globally

Pathomation’s worldwide presence, with distributor networks and users spanning Europe, Asia, and Latin America, ensures that AI-powered image analysis is accessible to more labs and more patients across the globe. Together, we’re removing geographic and technical barriers to bring state-of-the-art diagnostics to every corner of the world.

“Every partnership we form moves us closer to our goal: AI-powered image analysis in every lab, for every patient. Our collaboration with Pathomation is an important step toward making this vision a reality.” – Felix Faber, CEO, Mindpeak

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🔗 Learn more about the partnership and read the full press release: https://tissuepathology.com/2025/08/21/pathomation-and-mindpeak-forge-strategic-partnership-to-accelerate-ai-adoption-in-digital-pathology-workflows/

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Mindpeak Joins Techcyte Fusion Partner Program to Accelerate AI-Powered Digital Pathology

Mindpeak is proud to announce its new collaboration with Techcyte, a leading provider of AI-driven digital diagnostics, by joining the Techcyte Fusion™ Partner Program. This partnership brings together two pioneers in artificial intelligence for pathology, united by a mission to enhance diagnostic accuracy, efficiency, and reproducibility in cancer research and diagnostics.

Supporting Labs with Seamless AI Integration

Mindpeak’s suite of AI tools—including Research Use Only (RUO) algorithms for breast, prostate, and gastric cancer, alongside advanced IHC marker analysis—will now be available through the Techcyte Fusion™ platform. By integrating Mindpeak’s robust, explainable AI models, labs worldwide can benefit from interoperable solutions that fit naturally into existing workflows, supporting reproducible research and streamlined daily operations.

“We built Mindpeak to support pathologists with reliable, explainable AI that integrates effortlessly into daily routines,” said Felix Faber, Founder and CEO of Mindpeak. “Partnering with Techcyte allows us to reach more labs with a shared commitment to transforming cancer diagnostics through high-quality, scalable solutions.”

A Shared Vision for the Future of Pathology

The partnership underscores a shared vision: driving the future of digital pathology through validated, workflow-based AI. As labs face growing complexity and demand, collaborations like this will play a critical role in enabling faster, more precise insights and ultimately improving patient care.

Learn More
https://www.einpresswire.com/article/830144303/mindpeak-joins-techcyte-fusion-partner-program-to-accelerate-ai-powered-digital-pathology

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