Novian Health’s Novilase Breast Therapy Named Breakthrough Device

Novian Health has received a breakthrough device designation from the FDA for its Novilase interstitial laser system.

The proposed indication for the laser ablation device is the destruction of malignant breast tumors in adult women who seek a breast conserving procedure, the Chicago-based company said.

Novilase was previously cleared by the FDA for treating benign breast tumors. The system has also earned a CE mark for it to treat both malignant tumors and fibroadenomas.