FDA Grants Profound Medical Corp. IDE Approval for TULSA-PRO™
TORONTO, May 19, 2016 -- Profound Medical Corp. (PRN.V), an emerging medical device company focused on prostate care, today announced that it has been granted Investigational Device Exemption (“IDE”) approval from the U.S. Food and Drug Administration (“FDA”), for a multicenter Pivotal Clinical Trial (“Pivotal Trial”). The objective of this trial is to evaluate the efficacy of the TULSA-PROTM System in patients with localized prostate cancer.
TULSA-PRO is a unique technology that combines real-time Magnetic Resonance Imaging (MRI) with transurethral robotically-driven ultrasound and closed-loop thermal feedback control providing a highly precise prostate treatment tailored to patient-specific anatomy.
“We are delighted to announce that TULSA-PRO has received IDE approval,” commented Profound CEO, Steve Plymale. “With this approval, clinicians participating in the study will be able to further validate the efficacy of this innovative technology. The commencement of this multijurisdictional Pivotal Trial is a significant milestone for Profound as it aims to establish TULSA-PRO as a minimally invasive alternative to other prostate care therapies. This study is expected to set the path to 510k regulatory approval and we look forward to working with the FDA to bring this unique technology to clinicians and patients across the United States.”
- Published: 19 May 2016
- Written by Editor
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