Profound Medical’s TULSA-PRO Receives the US FDA’s 510(k) Clearance for Ablation of Prostate Tissue

 Profound Medical’s TULSA-PRO Receives the US FDA’s 510(k) Clearance for Ablation of Prostate Tissue

Profound Medical’s TULSA-PRO Receives the US FDA’s 510(k) Clearance for Ablation of Prostate Tissue

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

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

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