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US FDA Asks Prostate Ablation Device-Sponsors For More Clinical Safety Data To Support Clearances

Executive Summary

Almost four years after the agency first authorized a prostate ablation device, regulators have proposed a number of requirements for clinical studies that sponsors would have to meet to comply with special controls needed for the devices to be cleared for marketing.

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HIFU Face-Off: US Competition Begins For Prostate High-Intensity Focused Ultrasound

With the 510(k) clearance of EDAP TMS' Ablatherm HIFU and the first US procedure performed with SonaCare Medical's recently cleared Sonablate system, a European rivalry in high-intensity focused ultrasound machines for prostate cancer has moved to the US. And EDAP's CEO argues it was positive for long-term adoption that his firm's system ultimately gained 510(k) clearance as a surgical tool rather than the originally sought PMA approval for a prostate cancer indication.

De Novo Cleared For Sonablate Device After Panel Rejects PMA

The ultrasound unit for the ablation of prostate tissue was cleared via the de novo process. Last year, an FDA advisory panel recommended against approving a PMA on the device due to what the experts said were insufficient clinical trial results.

FDA Recommends Narrowed Indication For EDAP’s Ablatherm-HIFU

The agency sent EDAP TMS a not-approvable letter for its high intensity focused ultrasound device, asking the company to narrow its sought prostate cancer indication and provide additional safety and efficacy data by next spring.

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