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www.fdanews.com/articles/183369-csa-medical-wins-expanded-fda-clearance-for-trufreeze-cryotherapy

CSA Medical Wins Expanded FDA Clearance for TruFreeze Cryotherapy

September 6, 2017

Endoscopic cryo-ablation company CSA Medical won expanded 510(k) clearance for its TruFreeze spray cryotherapy system.

The system is now cleared for use on patients with Barrett’s esophagus with low grade dysplasia. The device was previously approved for high grade dysplasia as well as malignancies, the Boston-based company said.

The TruFreeze system is designed for use in dermatology, gynecology, general surgery, and to ablate benign and malignant lesions.

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