FDA Grants Clearance for CoolCryo Enabling U.S. Market Entry
February 13, 2026
The Management Board of Medinice S.A. (the "Company"), with reference to current reports No. 14/2025 and 2/2026, informs that on 13.02.2026 the Company received from the U.S. Food and Drug Administration ("FDA") clearance under the 510(k) procedure confirming the substantial equivalence of the CoolCryo medical device to a predicate device. Receipt of the clearance means the right to place CoolCryo on the market in the United States.
The Management Board of the Company indicates that obtaining FDA clearance constitutes a significant milestone in the implementation of Medinice S.A.'s development strategy in the scope of commercialization of the CoolCryo project on the U.S. market. The Company will inform about further significant events related to the implementation and development of the project in the form of relevant current reports.
CoolCryo is a medical device intended for the treatment of cardiac arrhythmia by performing cardiac surgical cryoablation.
About Medinice S.A.
Medinice is a medtech company listed on the Warsaw Stock Exchange, specializing in the development of a portfolio of novel solutions in cardiology and cardiac surgery. The company focuses on the design, clinical research, and commercialization of high-potential medical devices aimed at significantly improving patients' quality of life.
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