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.

ProSense, which destroys tumors by freezing them, was designed as an alternative to breast conserving surgery, or lumpectomy, the current standard of care. The system works by harnessing the power...

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