1. Medtech Insight

Advisory Panel Recommends FDA Approve Marketing Authorization For Novel Breast Cancer Treatment

 
• By Brian Bossetta

The US FDA’s advisory panel on general and plastic surgery devices voted in favor of agency approval for a novel medical device for treating early stage, low-risk breast cancer as a potential alternative to lumpectomy. The agency is expected to make its decision on the device early next year.

In a 9 to 5 vote, the FDA’s General and Plastic Surgery Devices Advisory Panel recommended the agency approve a de novo classification request from the Israeli firm IceCure Medical for its ProSense Cryoablation system.

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