Connected Solutions For Self-Injection
From enabling connected clinical trials to supporting digital therapy management, our solutions help improve clinical trial operational efficiency and data quality, strengthen commercial success, and empower patients to self-manage their therapy.
Access to reliable injection data is becoming increasingly important across both clinical development and commercial therapy management. Ypsomed combines connected injection devices with integrated digital solutions. From enabling connected clinical trials to supporting digital therapy management, our solutions help improve clinical trial operational efficiency and data quality, strengthen commercial success, and empower patients to self-manage their therapy.
SmartPilot
Combine SmartPilot with YpsoMate and begin capturing accurate, unbiased injection data while enabling intuitive, step-by-step user guidance. Transforming the proven YpsoMate autoinjector into a fully connected digital health solution facilitates your big data strategy.
SmartPilot's ergonomic, user-centric design ensures an effortless injection experience. Seamlessly integrated with Ypsomed Digital Health, it empowers patients to confidently manage their therapy.
SmartPilot is compatible with both YpsoMate 1 mL and 2.25 mL autoinjectors.
Now FDA 510(k) cleared
SmartPilot has received 510(k) clearance from the US. Food and Drug Administration (FDA), securing market access. A 510(k) clearance indicates that the device has been demonstrated to be as safe and effective as, that is, substantially equivalent to, a legally marketed predicate device, in accordance with applicable FDA requirements.
CliniPilot
Ypsomed’s CliniPilot is an innovative add-on technology available in two versions, for YpsoMate 1 mL and YpsoMate 2.25 mL autoinjectors, transforming them into smart, connected devices, enabling connected clinical trials. It automatically captures and securely transmits key injection data – including time, date, injection outcome, and any identified user errors that may occur – via Bluetooth to a companion app. The app formats the data to be fully compatible with major Electronic Data Capture (EDC) systems and transmits it, ensuring that pharmaceutical partners retain full ownership of the data. Seamlessly embedded in current workflows, CliniPilot supports pre-approval trials and post-approval RWE programs across traditional, hybrid, and fully decentralized models. Developed in line with regulatory guidance without the need for regulatory clearance – enhancing flexibility, efficiency, and scalability.