Innoblative Gets Breakthrough Status for Breast-Conserving Surgery Device

Innoblative Designs has received Breakthrough Device designation for its SIRA radiofrequency (RF) ablation device for use in breast-conserving surgery, often referred to as “lumpectomy.”

RF ablation has been shown to reduce repeat surgeries and may also reduce local recurrence, the company said.

Innoblative's SIRA device’s spherical shape delivers RF energy to the entire surgical cavity, yielding more consistent ablation depths than conventional RF devices, the company said.

The Breakthrough Devices program gives timely access to medical devices by speeding up their development, assessment and review.

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