DNV Selected to Certify Noul’s Malaria Blood and Cancer Testing Solutions for EU Market

DNV Selected to Certify Noul’s Malaria Blood and Cancer Testing Solutions for EU Market

(IN BRIEF) DNV has partnered with Korean diagnostics company Noul to certify its AI-powered malaria, blood cell and cervical cancer testing solutions under the EU In Vitro Diagnostic Medical Device Regulation. Acting as an IVDR Notified Body, DNV will assess three miLab™ cartridges built on Noul’s point-of-care diagnostic platform, supporting the company’s plans for European and global market access. The collaboration combines Noul’s advanced AI-driven diagnostics with DNV’s regulatory and certification expertise to help bring innovative testing solutions to healthcare providers worldwide.

(PRESS RELEASE) SEOUL, 14-Jan-2026 — /EuropaWire/ — DNV has entered into a partnership with Korean AI-driven diagnostics company Noul to support the certification of its malaria diagnosis, blood cell morphology and cervical cancer testing solutions under the European Union’s In Vitro Diagnostic Medical Device Regulation (IVDR). The collaboration will enable Noul to progress the regulatory approval of its innovative diagnostic technologies for access to European and international markets.

The EU IVDR establishes a comprehensive regulatory framework to ensure the safety, performance and clinical effectiveness of in vitro diagnostic medical devices. Under the regulation, most IVD products must obtain certification and a CE mark before they can be placed on the EU market. As the CE mark is also recognised in many other regions worldwide, IVDR compliance serves as an important gateway for global commercialisation.

Acting in its role as an IVDR Notified Body, DNV will carry out certification activities for three of Noul’s solutions built on the company’s miLab™ point-of-care diagnostic platform. These include the miLab™ MAL cartridge for malaria diagnosis, the miLab™ BCM cartridge for blood cell morphology analysis and the miLab™ CER cartridge for cervical cancer testing. The miLab™ platform integrates sample preparation, digital imaging and artificial intelligence–based analysis to deliver consistent, high-quality diagnostic results while supporting efficient workflows in a wide range of healthcare settings, from advanced hospital laboratories to remote clinics.

The certification process represents an important step in Noul’s international growth strategy, as demand increases globally for rapid, accurate and accessible diagnostic solutions. By working with DNV’s medical device certification specialists, Noul aims to accelerate the availability of its AI-powered diagnostics while meeting stringent regulatory requirements.

DNV brings extensive experience in medical device assurance and regulatory certification, supported by a global network of auditors, technical assessors and clinical experts. Through this partnership, DNV will support the timely and efficient certification of Noul’s technologies, helping innovative diagnostic solutions reach healthcare providers with confidence in their safety, accuracy and performance.

About DNV

DNV is a trusted Notified Body for medical device certification under the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). We provide independent, rigorous, and transparent assessments to ensure that medical devices placed on the market are safe, effective, and reliable throughout their lifecycle.

Our role goes beyond compliance, we partner with manufacturers to navigate complex regulatory requirements, balancing innovation with patient safety and quality. With deep technical expertise and global reach, DNV supports customers in achieving market access, maintaining regulatory integrity, and building trust in their products.

Driven by our purpose to safeguard life, property, and the environment, we help advance patient safety and healthcare outcomes while enabling manufacturers to thrive in a rapidly evolving regulatory landscape.

Learn more at https://www.dnv.com/medical-devices/

About Noul Co., Ltd.

“Enabling blood and cancer diagnostics anywhere in the world with AI.”

Founded in December 2015, Noul (376930.KQ) is an on-device AI healthcare company with a mission to explore global challenges that threaten human health and life, discover novel solutions, and realize those possibilities. Noul has commercialized the world’s first AI-powered diagnostic lab, miLab™, through convergence of AI, biotechnology, and compact robotics.

The miLab™ is the only solution that fully automates the microscopic diagnostic process—from sample preparation to AI-based image analysis—delivering lab-grade blood and cancer diagnostics at the point of care. Within 15 minutes, miLab™ produces precise results even in low-resource settings.

In 2022, miLab™ was described in a UNITAID report as “The most advanced digital microscope and fully integrated bench-top platform” for malaria diagnostics. It is now deployed in 28 countries, used by pharmaceutical companies, hospitals, labs, and public health institutions worldwide.

With strong clinical validation and proven performance, Noul is rapidly expanding its market presence, especially in malaria, blood analysis, and cervical cancer diagnostics. The company’s vision is to make a meaningful impact on the lives of 1 billion people worldwide through accessible, innovative diagnostic technologies.

Website: https://noul.com

Media contact:

Lakshmy Gowrishankar
Head of Regional Marketing & Communications, APAC & Greater China
+656583180512
Lakshmy.Gowrishankar@dnv.com

Sung Hwa Bae
Auditor
Sung.Hwa.Bae@dnv.com

SOURCE: DNV