Profound Medical Secures FDA 510(k) Clearance For Thermal Boost Module

(RTTNews) - Profound Medical Corp. (PROF) has announced that the FDA has granted 510(k) clearance for its Thermal Boost module to be used alongside TULSA-PRO.

TULSA-PRO is a technology that allows surgeons to remove all or part of the prostate gland in patients with low, intermediate, or high-risk prostate cancer, as well as benign prostatic hyperplasia (BPH), making TULSA-PRO one of the most versatile technologies for treating prostate diseases.

To further enhance the TULSA-PRO technology, the company. is developing a series of software modules that will work in tandem with it. These modules will provide customization, ease of use, and more confidence in clinical outcomes. The company plans to market these new modules under the name 'TULSA AI.'

Moreover, the company is also focused on creating an AI-driven automated treatment plan module. This module will utilize a database of successful treatment designs curated by physicians. The company is currently working with the FDA to achieve clearance for this module.