Singapore Regulators Clear AI Software Tool for Bladder Cancer Detection

Intelligent Scopes Corp. has earned Health Sciences Authority (HSA) clearance in Singapore for CystoSmart, an artificial intelligence-powered software tool for bladder tumor detection.

CystoSmart is designed to find bladder tumors in patients undergoing bladder screening and surveillance endoscopic examination. Brand agnostic and compatible with flexible and rigid scopes— including single-use scopes—the device is intended for use with white light cystoscopy to help clinicians improve detection accuracy of bladder tumors in real-time and post processing conditions.

CystoSmart’s HSA clearance, which occurs 11 months after it was approved in Brazil, marks a significant milestone, according to the company. Not only does it clear CystoSmart for use in Singapore, but, through the ‘Access Consortium’ collaboration, it paves the way for accelerated regulatory clearances in Australia, Canada, Switzerland and the United Kingdom, countries that are part of the Access Consortium group.

Bladder cancer is the tenth most common cancer worldwide, and the sixth most common malignancy in men. With increasing incidence globally, bladder cancer has a high rate of progression and recurrence (up to 80%) requiring repeated follow up examinations. White light cystoscopy is the standard and most widely used method for bladder tumor detection and surveillance; however, as per published studies, between 10% and 20% of bladder tumors are regularly missed by standard white light cystoscopy.

“Early identification of cancer translates to improved clinical outcomes, impacting positively on the patient journey and overall health economy,” Intelligent Scopes Corp. Chief Surgical Officer Dr. Rajesh Nair said. “Accurate exclusion reduces inappropriate investigations, which carry a physical and psychological burden for patients. Early detection or exclusion of bladder cancer allows for more effective resource utilization. CystoSmart can be used as an aid for urologists to improve detection accuracy—to reduce missed tumors and reduce unnecessary invasive biopsies and interventions.”

As per clinical and technical evaluations conducted, CystoSmart has a sensitivity (true positive rate) of more than 95% and a specificity (true negative rate) of over 98% in bladder tumor detection.

Intelligent Scopes Corp, a subsidiary of Claritas HealthTech, leads global endoscopic solutions deployment. The company provides state-of-the-art image processing and enhancement software medical devices and AI diagnostic tools for urology and gastroenterology. The company focuses on image processing, image enhancement, AI diagnostic tools, and robotic guidance systems for endoscopy procedures to improve detection rates, reduce unnecessary biopsies, and enhance patient outcomes.