Amsterdam, the Netherlands – WSK Medical is proud to announce the CE-MDR approval of Zeno AI, the first artificial intelligence solution on the market designed for the real-time detection and classification of head and neck cancers during routine endoscopic examinations, currently focused on the throat. This groundbreaking technology promises to transform head and neck cancer diagnostics and enhance patient outcomes through its precision and speed.
Head and neck cancers are notoriously difficult to diagnose early, often requiring a combination of physical exams, imaging tests, and biopsies. Traditional methods can be time-consuming and sometimes inconclusive. Zeno AI streamlines this process by providing immediate analysis and insights during a routine endoscopic examination, significantly reducing the time between suspicion and diagnosis. This capability is crucial for catching head and neck cancers at a stage when they are most treatable.
How Zeno AI works
For detection of laryngeal lesions in the outpatient clinic, a digital flexible transnasal endoscopy is performed. ‘Pre-stadium’ of laryngeal cancer (e.g. dysplasia) or early-stage laryngeal cancer (e.g. carcinoma in situ) can be difficult to detect. In a recent study by Scholman et al. among 111 observers with different levels of clinical expertise in ear, nose and throat (ENT) medicine, the authors state that the overall sensitivity of correctly identifying a specific histological entity during high definition was 66.3%. Thus, almost 33% of laryngoscopic diagnosis is incorrect.
Using Zeno AI will give ENT physicians a real-time AI analysis solution for early laryngeal cancer detection and classification that can be utilised during a routine endoscopic examination (laryngoscopy). Its real-time analysis allows the ENT physician to get instantaneous feedback and to make informed decisions on the spot, all while being easy to use and simple to understand. In addition, Zeno AI is not connected to the internet and does not store patient data, so it can be connected to existing endoscopic systems as a plug-and-play solution. Faster laryngeal cancer diagnosis can reduce healthcare costs and enable a faster care plan and potentially increase the survival rate of patients.
Significance of (EU) CE-certification
The CE-certification signifies that Zeno AI meets stringent medical safety and effectiveness standards set by the European Union (EU). This certification not only validates the technology but also enhances WSK Medical’s credibility in the healthcare market. Patients can now access cutting-edge technology that could improve survival rates and quality of life, while healthcare providers gain a powerful tool to enhance diagnostic accuracy and efficiency.
A snapshot of Zeno AI’s prediction of a Malignancy in the larynx in real-time during a routine endoscopy.
“It has been a long journey writing our Technical File that started off with Jonathan Woodburn (CTO) and myself. We were so lucky that Leon Doorn of MedQAIR came on board to assist us. Thanks to MedQAIR we were able to speed up the process significantly and we could not have done it without Leon and his team. It feels very rewarding to finally have the CE-certification for Zeno AI, a product that I think will revolutionize the ENT field. I am looking forward to exciting things ahead and going live in the EU and other markets that accept CE-certification” says Marius Wellenstein, CEO and founder of WSK Medical.
Looking ahead
As Zeno AI becomes more widely adopted and further enhanced to cover the entire Head and Neck area, it has the potential to set a new standard for Head and Neck cancer diagnostics. This innovative solution not only highlights the transformative potential of AI in healthcare but also inspires further research and development in AI-driven medical solutions.
For more information about Zeno AI and its capabilities, please visit Zeno AI’s product page.
About WSK Medical
WSK Medical is a global leading Artificial Intelligence software solution provider that focuses on the development and deployment of AI software solutions for the early detection and classification of cancer. Our aim is to bring you the most advanced AI technologies to assist clinicians and doctors. We do this by working in partnership, to develop high performing and secure AI software as a medical device for oncology purposes. For more information about our AI solutions, please contact us.
