CE mark for AI-supported health monitoring platform by Zana Technologies

EIT Health E-boat participant Zana Technologies has received the Class I Medical Device CE Mark for its AI-supported health monitoring platform Tidda AI.

Have you experienced pain in the last three days? Do you notice signs of inflammation in your wound? These are the typical questions Tidda AI will ask users to gather a holistic view on a patient’s health. The platform applies Conversational AI technology through chatbot-and speech assistance that helps to automate the communication with the patient, to capture their symptoms and reported outcomes, while enabling the monitoring and detection of clinical events. Additionally, the start-up also offers a health watch that tracks blood pressure, heart rate, steps, blood oxygen, and sleep. The solution empowers doctors to continuously stay updated on the status of their patients’ health and recovery. It allows patients to recover at home well and securely, while freeing up precious medical resources, keeping high-risk patients away from possibly crowded clinics, and reducing costs.

The CE certification mark assures that Tidda AI, which is the flagship product of Zana Technologies, conforms to the stringent requirements of the Medical Devices Directive 93/42/EEC. The directive outlines safety and performance requirements for medical devices within the EU market so that a product bearing the CE mark can be freely sold.

The CE certification mark is a key milestone in the business development strategy for Zana Technologies, a young and fast-evolving company. It is an important step towards reimbursement in the German healthcare system, while also bearing weight as a seal of quality approval for expansion into other markets.

Dr. Armand Brahaj, the Chief Technology Officer of Zana states: “For the CE mark certification, our team followed a challenging and stringent process in order to carefully comply with the requirements of the medical device directive. The work undertaken to earn the CE mark encompassed a broad series of actions and software development encompassing strict checkpoints and quality assurance measures. We fully revised our software lifecycle processes, including verification and validation, while carefully assuring the usability of the software to minimize any risks. A lot of effort was put in the engineering of a secured system that assures high data protection, full encryption and anonymization of patient information”.

For the German market, the CE mark is an important milestone for Tidda AI to earn Statutory Health reimbursement in the frame of the new Digital Healthcare Act. The act enables a DiGA – digital health application certified as CE-marked medical device – to be prescribed by a physician and get reimbursed by the public health insurance covering over 73 million persons in Germany.

Since securing the CE Mark, Zana has actively commenced operations to validate the Tidda AI solution in strict clinical settings through controlled trials by forming partnerships with renowned University Hospitals in Germany.