FDA Requests Removal of Ablatherm Ultrasound System Software Settings
FDA requested the removal of specific energy treatment settings from 12 Ablatherm ultrasound systems in the U.S. pending clinical data evaluation.
- Product
- Ablatherm(R) Integrated Imaging, High Intensity Ultrasound System For Prostate Tissue Ablation Transrectal high intensity focused ultrasound (HIFU) ablation of prostate tissue
- Category
- Medical Device
- Distribution
- 6 states