De Novo Cleared For Sonablate Device After Panel Rejects PMA
This article was originally published in The Gray Sheet
Executive Summary
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.
You may also be interested in...
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.
FDA Panel Rejects Sonablate 450 HIFU Device For Prostate Cancer
The advisors voted almost unanimously that SonaCare Medical’s HIFU device did not have good enough data to support a positive risk-benefit profile, but they suggested the company could improve their trial design and try again.
UK Medtech Strategy Sets Out Schedule Of Milestones To FY 2026
Fourteen months on from the release of its inaugural medtech strategy, the UK MedTech Directorate has laid firm foundations and reports progress on initiatives aimed at improving technology adoption. A schedule of ambitious future timelines has also been published.