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FDA Approves Channel Medystems’ Cerene Endometrial Cryotherapy

 
• By Reed Miller

Cerene is indicated for endometrial cryoablation in premenopausal women. Channel's PMA is based on 12-month results from the CLARITY trial, which showed procedural success with Cerene in about 77% of patients.

FDA approved background, 3D rendering, blue street sign
• Source: shutterstock.com

US FDA has approvedChannel Medsystems Inc.’s Cerene cryotheraphy device for endometrial cryoablation in premenopausal women with heavy menstrual bleeding due to benign causes for whom childbearing is complete, the agency announced March 28.

Cerene uses nitrous oxide to freeze and ablate the endometrium to reduce future menstrual bleeding due to benign causes in premenopausal women. Cerene competes with second-generation “global” endometrial ablation technologies...

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• By Shubham Singh

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