FDA clears SonaCare HIFU prostate device, prompts Edap to yank de novo, go for 510k

SonaCare said it won FDA pre market approval for its high intensity focused ultrasound device designed to treat prostate cancer, causing competitor EDAP (NSDQ:EDAP) to yank the de novo application for its Ablatherm HIFU. SonaCare said its Sonablate 450 will be available in the U.S. this October. “The FDA regulatory authorization to market Sonablate in the U.S. is a milestone for non-invasive prostate care and a tremendous gain for men’s health. Men all over the world, in the more than 49 countries where it has already been authorized for use, have had access to this technology for prostate ablation. There are numerous peer reviewed articles attesting to its value in ablating the prostate while minimizing the occurrence of side effects. Our company is appreciative of the collaborative efforts made on the part of the FDA to bring this technology to the U.S.,” SonaCare CEO Dr.Mark Carol said in a press release. The Sonablate is SonaCare’s 2nd medical device to win clearance, having won 510(k) clearance for its Sonatherm laparoscopic high intensity therapeutic 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,” Carol said in prepared remarks. The approval caused therapeutic ultrasound company EDAP to withdraw the de novo application for its Ablatherm device to pi...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Food & Drug Administration (FDA) Oncology Pre-Market Approval (PMA) Regulatory/Compliance EDAP TMS SA SonaCare Medical Source Type: news

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Source: ClinicalTrials.gov - Category: Research Source Type: clinical trials
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