Sonablate® is the Company’s second medical device to receive U.S. FDA regulatory authorization, complementing the 510(k) cleared Sonatherm® laparoscopic HITU ablation device. “With the authorization to sell Sonablate® in the U.S., we can now offer a full HIFU surgical suite of technologies working off of the same basic platform and providing benefits throughout health care centers,” said Mark Carol.
“In addition,” Dr. Carol continued, “this de novo clearance, together with the CE Mark for Sonablate®500, will facilitate additional regulatory authorizations in markets beyond Europe and North America, further strengthening our world-wide market leadership in therapeutic HIFU devices.”
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About SonaCare Medical, LLC
SonaCare Medical is a world leader in minimally invasive focused ultrasound (HIFU) technologies. SonaCare Medical is committed to developing focused ultrasound related technologies that support precise and innovative procedures for the treatment of a range of medical conditions. SonaCare Medical, with its subsidiary Focus Surgery, Inc., designs and manufactures medical devices, including the following: Sonablate®, which has 510(K) clearance in the U.S. under a De Novo regulatory classification; Sonablate® 500, which has CE Marking and has obtained regulatory authorization in more than 49 countries outside the U.S.; Sonatherm® laparoscopic HIFU surgical ablation system, which has 510(K) clearance in the U.S., has CE Marking and has obtained regulatory authorization in more than 30 countries outside the U.S.
For additional information, visit http://www.SonaCareMedical.com
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