FDA Committee Gives Thumbs Up to Breast Cancer Lumpectomy Drug-Device Combo

The FDA’s Medical Imaging Drug Advisory Committee (MIDAC) last week green-lighted Lumicell’s device-injection combo product aimed at helping surgeons detect residual breast cancer in breast tissue after lumpectomies.

The committee voted 16 for, two against and one abstention when asked whether the benefits of the product outweigh the risks.

Many on the panel agreed that Lumisight’s success rate — helping only eight out of 357 participants to avoid a second breast surgery during the relatively small open label trial — wasn’t huge, but that it’s a good start for a product that will be the first of its kind.

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