RF Medical gains EU regulatory approval for its Mi-BLATOR microwave ablation system, marking a strategic expansion of its thermal ablation portfolio in the European market.
The Mi-BLATOR microwave ablation system received CE marking under the EU MDR on Nov. 10, 2026, covering both generator and antennas and opening the European market. This is a hard regulatory approval that extends the company's portfolio beyond radiofrequency ablation, supporting European expansion, though no revenue figures are given to size the benefit.
RF Medical Co., Ltd. announced on Nov. 10, 2026, that its Mi-BLATOR microwave ablation system received CE marking under the European Union's Medical Device Regulation. The certification covers both the generator and antennas, allowing the company to expand its European portfolio beyond radiofrequency ablation and enter new clinical markets.
Its Mi-BLATOR microwave ablation system obtained CE marking under the EU Medical Device Regulation, covering both the generator and antennas, allowing the product to be launched in Europe.
The approval adds microwave ablation alongside the company's radiofrequency portfolio and creates opportunities to reach new customers across Europe, though the announcement includes no financial figures on the expected impact.