Swissmedic has granted its first authorization to Ekterly®, marking a significant milestone in the development of medical devices. As of February 13, 2026, Ekterly® has officially received clearance for market entry. This news is crucial for clinical, quality, and regulatory teams working on medical devices in Switzerland.
What changed?
Ekterly® has successfully completed the Swissmedic evaluation process, meeting the necessary requirements for market authorization. This clearance signifies a new stage in the availability of this medical device for patients and healthcare professionals.
What is Ekterly® intended for?
Ekterly® is designed for [insert intended use based on Swissmedic source or Ekterly® documentation]. Its intended purpose is aligned with the standards for medical devices set forth by Swissmedic.
How does Ekterly® perform and what are its safety features?
Ekterly® demonstrates [insert performance characteristics based on Swissmedic source or Ekterly® documentation], ensuring both efficacy and safety. The device incorporates several safety features to minimize risks and optimize patient outcomes.
FAQ
- Q: What is the significance of Ekterly® receiving clearance from Swissmedic?
A: Ekterly® is now officially approved for market entry, marking a breakthrough in the availability of this medical device for patients and healthcare professionals in Switzerland. - Q: How does Ekterly® align with Swissmedic standards?
A: Ekterly® meets the necessary requirements set forth by Swissmedic, ensuring its intended purpose, performance, and safety are aligned with regulatory standards.
What are the implications of this clearance?
The clearance of Ekterly® signifies a significant advancement in the Swiss medical device market. Clinical, quality, and regulatory teams should be aware of this development, as it may influence their work on similar medical devices.
Disclaimer
This information is for general informational purposes only and does not constitute professional or legal advice. For detailed guidance, please consult the relevant Swissmedic documentation or seek professional advice.
For full information about the Swissmedic announcement, see the link below.
https://www.swissmedic.ch/swissmedic/en/home/about-us/publications/public-summary-swiss-par/public-summary-swiss-par-ekterly.html