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 Secures First Patent for Advanced AI in Digital Pathology

Mindpeak has been granted its first patent, marking an important milestone in the company’s mission to advance AI-powered pathology and precision diagnostics.

The patent protects a novel method for training artificial intelligence systems to accurately identify and classify different cell types in tissue samples. This technology addresses a critical requirement for reliable cancer diagnostics and reinforces the role of AI as a dependable decision-support tool for pathologists.

The patent has been issued across 18 European Union member states and validated in the United Kingdom, highlighting the originality, robustness, and clinical relevance of Mindpeak’s approach to digital pathology.

This achievement reflects the dedication and expertise of Mindpeak’s research, development, and engineering teams, whose work continues to advance the capabilities of medical AI.

For further information, please refer to the full press release:
https://www.globenewswire.com/news-release/2025/12/10/3202933/0/en/Mindpeak-Secures-First-Patent-for-Advanced-AI-Method-in-Digital-Pathology.html

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Accelerating AI Adoption in Pathology: Mindpeak x PathGroup

The role of AI in pathology isn’t just evolving – it’s accelerating. It’s helping pathologists turn complex data into faster, more consistent answers for patients. At Mindpeak, we’re proud to be part of that change. Today, we’re taking another big step forward through a new collaboration with PathGroup – one of the leading providers of anatomic, clinical, molecular and digital pathology services in the U.S.

This partnership goes beyond collaboration; it marks a powerful step toward bringing AI into everyday diagnostics. By combining Mindpeak’s proprietary image analysis technology with PathGroup’s extensive, pathologist-led network, we’re laying the groundwork for a new era of precision and efficiency in pathology.

Together, we’ll support pathologists integrate AI seamlessly into their workflows – enhancing speed, consistency and equity in diagnostics. The result: faster, more reliable insights for patients and more time for pathologists to focus on what matters most – patient care.

At Mindpeak, we believe the future of pathology is AI-augmented, not AI-replaced. Through partnerships like this, that future is becoming reality – one slide at a time.

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