EDAP Announces Milestones in Ablatherm-HIFU PMA Process
French ultrasound maker EDAP expects to achieve key milestones this summer in the premarket approval process for the Ablather-HIFU device. The device provides high-intensity, focused ultrasound treatment of localized prostate cancer.
According to the company, the FDA has scheduled a routine inspection of its manufacturing plant for June 23-26 and will audit clinical study sites in July as part of the clinical data validation process. EDAP will also have a panel of experts review clinical data and provide a recommendation on the device to the FDA, the devicemaker said Tuesday.
EDAP submitted a premarket approval application for the Ablatherm-HIFU in February.
"Having dates confirmed for these additional milestones is further great news for EDAP, as it demonstrates how quickly the FDA process is moving for our Ablatherm-HIFU PMA application,” said CEO Marc Oczachowski. “EDAP has successfully met the requirements of all of our previous FDA inspections and audits and is professionally organized in compliance with major quality assurance systems,” he added.
HIFU is a minimally invasive and effective treatment option for patients who are not candidates for surgery, prefer an alternative option or failed radiotherapy treatment.
EDAP’s Ablatherm-HIFU device is CE-marked and available in Europe. — Kellen Owings
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