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Latest news
- 2026-02-13
FDA Grants Clearance for CoolCryo Enabling U.S. Market Entry
Medinice S.A. received FDA 510(k) clearance on February 13, 2026, for the medical device CoolCryo, confirming its equivalence to a reference device. This marks a key step in bringing CoolCryo to the U.S. market for treating heart arrhythmias via cryoablation.
- 2025-11-07
Letter to Shareholders regarding the December 3, 2025 EGM
Medinice S.A. announces that the company continues to execute its key projects and commercialization activities in line with the adopted strategy. The investment agreement with the fund remains in effect, and an investor meeting summarizing 2025 will be held soon.
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