Medlight S.A. is a Swiss-based medical technology company that specializes in the development, manufacturing, and commercialization of optical diffusers and related devices such as needle and balloon catheters. These products are primarily used in Photodynamic Therapy (PDT) and Photoimmunotherapy, treatments that use light to activate drugs within the body to kill cancer cells. Medlight's primary market is the healthcare sector, serving hospitals, clinics, and other medical facilities worldwide.

The company operates on a business-to-business (B2B) model, selling its products directly to healthcare providers. It generates revenue through the sale of its medical devices and related products. In 2020, Medlight became part of the Rakuten Medical group, a move that has bolstered its industry presence while allowing it to continue operating as an independently managed subsidiary.

Medlight has a strong track record of regulatory compliance, having passed ISO certification audits without any major non-conformities. It has also received commercial approval for two product categories from the Japanese Ministry of Health, Labour, and Welfare. The company is committed to innovation, continuously developing new devices to meet patient needs.

However, Medlight is currently facing regulatory challenges due to changes in the Medical Devices Regulation in the European Union. The company is working to resolve these issues and obtain a valid CE mark under the new regulations.

Keywords: Medical Technology, Optical Diffusers, Photodynamic Therapy, Photoimmunotherapy, Healthcare Sector, B2B Model, Regulatory Compliance, Innovation, Medical Devices Regulation, CE Mark.