Shots:

• The FDA’s 510 (k) clearance is based on TACT clinical study involves assessing of TULSA-PRO in 115 patients with biopsy-proven- organ-confined prostate cancer and has received primary treatment of whole-gland prostate ablation with sparing of the urethra and urinary sphincter across the US- Canada and Europe
• The TACT clinical study resulted in meeting its 1EPs & 2EPs i.e- safe and effective prostate tissue ablation with significant prostate volume and PSA reduction with low rates of residual prostate disease
• TULSA-PRO is a CE marked transurethral prostate tissue ablation system combining MRI with robotically driven transurethral ultrasound and closed-loop temperature feedback control with its expected commercial launch in the US in Q4’19

Click here to­ read full press release/ article | Ref: Business wire | Image: MedGadget