US FDA Asks Prostate Ablation Device-Sponsors For More Clinical Safety Data To Support Clearances
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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Manufacturers developing devices to remove tissue in the prostate should provide the US FDA with follow-up information on patients that include certain indirect data about the long-term safety outcomes of using their product, according to a final agency guidance.
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.
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.