Lumendi’s CE Mark Signals European Expansion of Advanced Colonoscopy Tech

Zug, Switzerland – November 15, 2025 – Lumendi AG has received CE Mark certification for its DiLumen™ EZ and DiLumen™ C devices, clearing the way for commercial distribution of its advanced endoscopic platform across Europe. This milestone not only expands the reach of Lumendi’s minimally invasive technology, but also highlights the increasing demand for safer, more effective colonoscopy procedures – and the complex landscape of evolving medical device regulations.

The CE Mark certification confirms that Lumendi’s devices meet the stringent safety and performance requirements of the European Union’s Medical Device Regulation (MDR), a significantly updated framework intended to enhance patient safety and transparency. Achieving this certification, particularly under the MDR, is a considerable undertaking, demonstrating Lumendi’s commitment to quality and compliance.

“The MDR presents a higher bar for medical device manufacturers, requiring more comprehensive documentation and ongoing monitoring,” explains an industry analyst familiar with the European regulatory landscape. “Successfully navigating this process, as Lumendi has, is a testament to their robust quality management system.”

Disrupting the Colonoscopy Paradigm

Lumendi's DiLumen platform is designed to improve the efficacy and comfort of colonoscopies, a crucial procedure for detecting and preventing colorectal cancer. Traditional colonoscopies can be uncomfortable for patients and carry a small risk of perforation. The DiLumen platform utilizes a flexible, steerable catheter that allows physicians to navigate the colon with greater precision and control, potentially reducing discomfort and complications.

“The key benefit of this technology lies in its ability to enhance visualization and maneuverability within the colon,” says a gastroenterologist who has evaluated the DiLumen platform. “This can be particularly helpful in complex cases, such as those involving anatomical variations or prior surgical interventions.”

Clinical studies have shown that the DiLumen platform can improve diagnostic yield and reduce procedure times. A recent study published in a peer-reviewed journal demonstrated a 20% reduction in procedure times and improved detection of precancerous polyps. Over 6,000 procedures have been successfully performed worldwide using the platform.

Navigating the European Market

The European endoscopic devices market is estimated to be worth over $6 billion and is projected to grow at a compound annual growth rate of 7.1% through 2028. Key players in the market include Boston Scientific, Olympus, and Fujifilm. Lumendi aims to carve out a niche by offering a differentiated technology that addresses the limitations of traditional colonoscopy.

To accelerate its expansion in Europe, Lumendi has partnered with MICRO-TECH Endoscopy, a leading distributor of endoscopic devices in the UK and Ireland. This partnership will provide Lumendi with access to a well-established sales and marketing network, as well as a team of experienced application specialists.

“MICRO-TECH Endoscopy has a strong track record of successfully launching innovative medical technologies in the UK and Ireland,” notes an industry observer. “This partnership will be instrumental in driving adoption of the DiLumen platform in these key markets.”

The Evolving Regulatory Landscape

The implementation of the MDR has presented significant challenges for medical device manufacturers. The regulation requires more rigorous clinical evidence, increased post-market surveillance, and greater transparency. Companies must also demonstrate that their devices are safe and effective throughout their entire lifecycle.

“The MDR has forced companies to invest heavily in regulatory compliance,” explains a regulatory affairs consultant. “It’s no longer enough to simply meet the minimum requirements. Companies must demonstrate a proactive approach to risk management and continuous improvement.”

Lumendi’s successful navigation of the MDR highlights the importance of a robust quality management system and a commitment to regulatory compliance. The company has invested heavily in documentation, clinical evidence, and post-market surveillance.

“This certification isn’t just about ticking boxes,” says an anonymous Lumendi spokesperson. “It’s about demonstrating our commitment to patient safety and providing healthcare professionals with the tools they need to deliver the best possible care.”

Looking Ahead

With the CE Mark secured and a strong distribution partnership in place, Lumendi is well-positioned to expand its presence in the European market. The company plans to launch the DiLumen platform in several key countries over the next year, focusing on centers of excellence and early adopters of innovative technology.

“We believe that the DiLumen platform has the potential to transform the way colonoscopies are performed,” says the Lumendi spokesperson. “Our goal is to make this technology accessible to patients and healthcare professionals across Europe, improving outcomes and reducing the burden of colorectal cancer.”

The company is also exploring opportunities to expand its technology platform to other areas of endoscopy, such as upper endoscopy and bronchoscopy. With a growing portfolio of innovative products and a commitment to regulatory compliance, Lumendi is poised to become a leading player in the global endoscopy market.

The success of Lumendi's expansion will be closely watched by industry observers, as it signals a growing trend towards minimally invasive procedures and a greater emphasis on patient safety and quality in the medical device industry.