Profound Medical Announces Health Canada Approval of TULSA-PRO®
We are so pleased to share the announcement of Health Canada approval of the TULSA-PRO® system for the ablation of low to intermediate risk organ-confined prostate cancer.
TULSA-PRO® is a transurethral prostate tissue ablation system that combines real-time Magnetic Resonance Imaging (“MRI”) with robotically-driven directional thermal ultrasound and closed-loop temperature feedback control software to deliver predictable physician prescribed ablation of whole-gland or partial prostate tissue. The TULSA-PRO® system is designed to provide customizable and predictable, incision-free and radiation-free prostate ablation while actively protecting the urethra and rectum with water cooling to preserve men’s functional abilities.
“The positive Health Canada decision is key to our global expansion strategy for TULSA-PRO®, as many major market jurisdictions, such as China, have a ‘country of origin’ approval requirement for medical devices,” said Goldy Singh, Profound’s VP, Regulatory Affairs & Product Management.