Innoblative Receives U.S. IDE Approval for its Novel Electrosurgical Device for Breast Cancer Treatment
- Innoblative prepares to initiate its feasibility study, evaluating the safety and effectiveness of its SIRA® RFA Electrosurgical Device, an FDA Breakthrough Device, for patients undergoing breast-conserving surgery
- Breast cancer is the most commonly diagnosed cancer globally
CHICAGO, April 10, 2025 /PRNewswire/ — Innoblative Designs, Inc. (Innoblative), a private medical device company addressing clinical unmet needs for patients with breast cancer, announced today that the U.S. Food and Drug Administration has approved its Investigational Device Exemption (IDE) application, paving the way for the company to initiate its U.S. feasibility study. The study will evaluate the safety and effectiveness of the company’s SIRA® RFA Electrosurgical Device in patients undergoing breast-conservation surgery (BCS).
