Ypsomed: FDA Clears SmartPilot Connectivity Device For Use With Autoinjector Platform

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(RTTNews) - Ypsomed Holding AG (YPHDF) announced Monday that its digital connectivity add-on, SmartPilot, has received 510(k) clearance from the U.S. Food and Drug Administration or FDA.

SmartPilot captures key injection data, such as time and date, injection outcome, and potential user errors, and transmits it securely via Bluetooth to patients' smartphones. SmartPilot detects and identifies user errors and logs all relevant injection data, helping improve the safety and reliability of self-injection.

With automatic and real-time data collection, the device supports both clinical development and day-to-day therapy management.

The company noted that SmartPilot is the first and only FDA-cleared connectivity device specifically designed for use with an autoinjector platform. All FDA-cleared devices for capturing injection data until now have been limited to pen injectors, primarily used in diabetes treatment.

The new device transforms the YpsoMate autoinjector into a connected system that automatically captures and transmits injection data.

Ulrike Bauer, Chief Business Officer, said, "The FDA clearance of SmartPilot authorizes the device to be legally marketed and demonstrates its readiness to support our partners in both clinical trials and commercial applications. This is an important step forward in advancing digital technologies for self-injection and selfcare. It validates our commitment to intelligent, patient-centered design and strengthens our partnerships with pharmaceutical companies and digital health partners."

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