Innoblative Designs, Inc. They have received Breakthrough Device Designation from the U. S.

Food and Drug Administration (FDA) for their innovative SIRA™ RFA Electrosurgical Device (SIRA). Specifically designed for breast cancer patients undergoing BCS (lumpectomy), the SIRA device has a unique spherical shape that enables circumferential delivery of RF energy. This feature ensures reproducible ablation depths, providing greater confidence in achieving a consistent thermal effect.

Although the SIRA™ device is currently investigational and not available for sale in the United States, it holds the promise of revolutionizing the treatment of breast cancer by offering more precise and effective thermal ablation. Innoblative Designs, Inc