FDA accepts HIFU maker’s pre-market application
EDAP TMS said the FDA has provided a positive filing review notification on the company’s pre-market approval application for its Ablatherm Integrated Imaging HIFU (high-intensity focused ultrasound) device for the treatment of low-risk, localized prostate cancer.
EDAP TMS said the FDA has provided a positive filing review notification on the company’s pre-market approval application for its Ablatherm Integrated Imaging HIFU (high-intensity focused ultrasound) device for the treatment of low-risk, localized prostate cancer.
HIFU is approved as a treatment of prostate cancer in a number of countries but is still considered investigational in the United States.
The FDA conducted a filing review of EDAP’s application, and found it to contain all of the information needed to proceed with the substantive review, in which the FDA will evaluate the safety and effectiveness of the Ablatherm device, as well as EDAP’s engineering, manufacturing, and quality systems, the company said.
“We are moving forward in the pre-market approval review process as the agency commences its substantive review. We will continue to work closely with the FDA review team,” said Marc Oczachowski, of EDAP.
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