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Profound Medical’s Contouring Assistant AI Module Gains the US FDA’s Approval for Creating Automated TULSA Treatment Plan

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Profound Medical

Profound Medical’s Contouring Assistant AI Module Gains the US FDA’s Approval for Creating Automated TULSA Treatment Plan

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  • The US FDA has granted 510(k) clearance to the company’s Contouring Assistant TULSA-AI module to be used in combination with the TULSA-PRO system, based on a standalone study of Contouring Assistant vs Reference Standard in prostate cancer cases (n=100) & an MRMC study by various radiologists & urologists
  • The standalone study depicted Contouring Assistant’s non-inferior and its ability to contour 100 prostate cases with an average Sørensen–Dice coefficient of 0.910 +/- 0.031
  • The MRMC study showed that MRMC readers were accurate but 29% faster on avg. in contouring. Another 3 urologists demonstrated improved segmentation accuracy, being 32% faster on average

Ref: Profound Medical | Image: Profound Medical

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

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Disha Nankani

Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.

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