Aiforia secures IVDR certification, paving the way for expanded clinical portfolio in Europe
Aiforia obtained the In Vitro Diagnostic Regulation (IVDR) certification and successfully launches three new CE-IVD marked AI solutions for breast and prostate cancer diagnostics
Aiforia Technologies Plc, Press Release, February 20, 2025 at 10:30 a.m. EET
Aiforia Technologies Plc, a provider of cutting-edge AI-assisted medical software solutions, announced today that it has successfully obtained the In Vitro Diagnostic Regulation (IVDR) certification. At the same time, the company launches three new CE-IVD marked AI models for breast and prostate cancer diagnostics. The certification was granted by a notified body, BSI Group. The certificate confirms that Aiforia complies with the requirements of the IVD Regulation 2017/746, and enables Aiforia to bring an expanded portfolio of AI models to the European market.
“We are excited and proud to receive the IVDR certification. This is a significant milestone for Aiforia, and enables us to introduce a broader range of products to the cancer diagnostics market in Europe. The certification shows that Aiforia’s clinical solutions meet stringent safety, performance, and risk management requirements according to the IVDR. The company’s commitment to regulatory compliance and patient safety strengthens its position as a trusted partner for healthcare providers,” says Jukka Tapaninen, CEO of Aiforia.
Aiforia® Breast Cancer HER2 AI model assists pathologists in accurately assessing HER2 status in breast cancer tissue samples, aiding in crucial treatment decisions. The HER2 AI model is part of the Aiforia® Breast Cancer Suite, which consists of several AI models and the Aiforia® Clinical Suite Viewer.
Aiforia® Prostate Cancer Gleason 4 Cribriform and Perineural Invasion (PNI) AI models assist pathologists in detecting these patterns in whole slide images (WSI) of prostate tissue. These AI models are part of the Aiforia® Prostate Cancer Suite, which consists of several AI models and the accompanying Aiforia® Clinical Suite Viewer.
The Aiforia® Clinical Suites provide pathologists with an intuitive and interactive user interface for accessing and analyzing digital pathology images with the support of AI, streamlining workflows, and facilitating collaboration.
The In Vitro Diagnostic Regulation (IVDR) establishes a robust regulatory framework for diagnostic medical devices within the European Union. Implemented in 2022, the IVDR replaces the In Vitro Diagnostic Directive (IVDD) with a more comprehensive and stringent set of requirements. These updated standards aim to enhance patient safety, ensure product quality and performance, and harmonize European regulations. Key changes introduced by the IVDR include stricter clinical evidence requirements, enhanced post-market surveillance, and a new risk-based classification system.
Read more about the new products at the company’s website www.aiforia.com.
Further inquiries
Jukka Tapaninen, CEO, Aiforia Technologies Plc
tel. +33 61 041 6686
https://investors.aiforia.com/
Certified Adviser
UB Corporate Finance Ltd
ubcf@unitedbankers.fi
About Aiforia
Aiforia is a trusted provider of deep learning artificial intelligence (AI) solutions for pathology. Aiforia delivers software solutions that elevate diagnostic capabilities in image analysis, enabling remarkable medical discoveries now and in the future. With thousands of AI models already developed on the Aiforia platform for research use and several diagnostic solutions deployed, Aiforia is already significantly impacting pathology and healthcare.
Founded in 2013, Aiforia is a publicly traded company operating internationally with thousands of platform users across the globe. The company is headquartered in Helsinki, Finland, with offices in Cambridge, Massachusetts, and Rochester, Minnesota, and local representatives across Europe and North America. The diverse team at Aiforia includes experienced pathologists, medical scientists, AI and software developers, and a dedicated commercial team. Together, they are working to transform pathology with AI, enabling better care for each patient.
Find out more at www.aiforia.com
SOURCE: Aiforia
