The device transforms the YpsoMate into a connected system that automatically captures and transmits injection data. Ypsomed said this marks an important step toward digital health solutions that offer deeper insight into therapy use. The digital add-on also enables objective monitoring and supports improved adherence and treatment outcomes.
Burgdorf, Switzerland-based Ypsomed said FDA clearance for SmartPilot demosntrates its readiness to support partners in clincial trials and commercial applications in the U.S.
SmartPilot captures key injection data like time and date, injection outcome and potential user errors. It transmits this data securely via Bluetooth to patients’ smartphones. Enabling automatic and real-time data collection supports both clinical development and day-to-day therapy management.
Ypsomed said clearance made SmartPilot the first and only FDA-cleared connectivity device specifically designed for use with an autoinjector. It said previous FDA-cleared devices for capturing injection data were limited to pen injectors, primarily for diabetes treatment.
SmartPilot has compatibility with subcutaneously administered medications, including both small molecules and biologics. The technology guides patients through each injection step via visual and acoustic signals. This scalable digital platform supports adaptive clinical trial design, market introduction and individualized care strategies.
“This is an important step forward in advancing digital technologies for self-injection and self-care. It validates our commitment to intelligent, patient-centered design and strengthens our partnerships with pharmaceutical companies and digital health partners,” said Ulrike Bauer, Ypsomed chief business officer.
