US EditionInnoblative Receives U.S. IDE Approval for its Novel Electrosurgical Device for Breast Cancer Treatment
- Innoblative announced on April 10, 2025, in Chicago, that the FDA approved its IDE application for the SIRA device.
- Breast cancer's high re-operation rates and difficult radiation treatments drive the need for alternative options like the SIRA device.
- The SIRA device, designed for breast-conserving surgery, uses radiofrequency energy to ablate residual cancer in the post-lumpectomy cavity.
- Richard Stark, Innoblative's CEO, stated IDE approval was a 'significant milestone' and he anticipates the technology to 'be a game-changer'.
- Innoblative will begin a U.S. Feasibility study to validate SIRA's safety and effectiveness, potentially reducing reoperations and radiation needs.
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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 surgeryBreast cancer is the most commonly diagnosed cancer globally1
·Denton, United States
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FDA approves Innoblative’s IDE for electrosurgical device for breast cancer
The FDA has granted approval for Innoblative Designs' IDE application, allowing it to commence a feasibility study in the US.The post FDA approves Innoblative’s IDE for electrosurgical device for breast cancer appeared first on Medical Device Network.
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