Derisk market access for pharmaceutical companies wanting to integrate Ypsomed's digital health
Ypsomed has received FDA 510(k) clearance for SmartPilot, a digital add-on that transforms the YpsoMate autoinjector into a connected device. SmartPilot automatically captures injection data—such as time, injection outcome, and user errors—and transmits it via Bluetooth to patients’ smartphones. This milestone reinforces Ypsomed’s commitment to intelligent, patient-centered design and paves the way for smarter, data-driven selfcare. This clearance enables:
Reduce Time to Market
This approval is a milestone that reduces time to market for any pharmaceutical company wanting to integrate Ypsomed’s digital health with their drug.
Broad Applications
As the first FDA-cleared connectivity solution for autoinjectors, SmartPilot serves as a predicate device for any future FDA submissions, thereby paving the way for future therapy areas.
Safe and Effective Connected Devices
SmartPilot enhances self-injection safety, enables real-time monitoring, and empowers healthcare providers with insights.
What is 510(k) Clearance?
A 510(k) is a premarket notification to the FDA, demonstrating that a medical device is safe and effective by proving it is substantially equivalent to a device that is already on the market. It thereby:
- ensures regulatory compliance
- confirms the safety and efficacy of the product
- authorizes the marketing of SmartPilot in the US
This regulatory pathway is independent from the drug approval process.
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Disclaimer
SmartPilot is intended for the capture and recording of injection data from compatible autoinjectors to provide comprehensive user feedback using visual indicators and audible signals to guide users throughout the injection process. It is not specifically indicated for the treatment, prevention, cure, or diagnosis of a disease or condition. Although SmartPilot may enhance the user experience, the therapeutic effect is provided solely through the use of the delivered drug under the supervision of a qualified healthcare provider. If you have questions about the SmartPilot, your treatment, or your medical condition, please consult a qualified healthcare professional.
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