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Novian Health Inc. has been granted Breakthrough Device designation from the U.S. Food and Drug Administration for its Novilase®Interstitial Laser System and its proposed indication for use: the focal destruction of malignant breast tumors in adult women who seek a breast conserving procedure.
The FDA’s Breakthrough Device program supports the timely development of technologies that have the potential to provide more effective treatment of life-threatening diseases. By obtaining this status, Novian will benefit from an expedited regulatory review process, which may accelerate access to its interstitial laser therapy system in the United States.
“Laser therapy can help patients avoid the trauma and risks of breast cancer surgery,” said Henry Appelbaum, president and CEO of Novian Health. “Receiving this designation is a significant milestone that moves us one step closer to offering the benefits of this game-changing technology to breast cancer patients in the U.S.”
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