AI-powered digital diagnostics company Techcyte has announced that its Fusion AP platform has achieved CE marking under the European In Vitro Diagnostic Regulation (IVDR).
Fusion AP is designed to support digital pathology workflows through high-performance slide viewing, enterprise scalability, and truly integrated AI-driven analysis support. With the CE-IVDR marking, European laboratories can adopt Fusion AP with regulatory assurance aligned to current EU requirements.
The device is now registered with the German Competent Authority and authorised for commercialisation across the European Economic Area.
“IVDR compliance is a critical milestone not only for regulatory readiness, but for the long-term sustainability of digital pathology in Europe,” said Ben Cahoon, Chief Executive Officer of Techcyte. “This achievement reflects our commitment to rigorous quality systems, robust clinical validation, and responsible AI deployment. It provides European laboratories with confidence that Fusion AP meets the highest regulatory standards.”
The IVDR represents one of the most significant regulatory shifts in European diagnostics in decades, raising requirements for clinical evidence, risk management, post-market surveillance, and quality systems. Achieving CE marking under IVDR confirms that Fusion AP meets these strengthened standards and is approved for clinical use within its intended purpose across Europe.
As laboratories across Europe transition from legacy directives to IVDR-compliant systems, regulatory clarity has become a key factor in vendor selection. By securing CE marking under IVDR, Techcyte positions Fusion AP as a compliant and future-ready solution for digital pathology programs seeking scalability, performance, and regulatory alignment. The CE-IVDR mark enables Techcyte to market and deploy Fusion AP throughout the European Economic Area, supporting hospitals, laboratory networks, and pathology groups in their transition to digital-first workflows.