Intelligent Scopes Corp, a leader in AI-powered image enhancement and precision software for urology and gastroenterology, has announced  that its CystoSmart platform has received regulatory clearance from Singapore’s Health Sciences Authority (HSA), paving the way for global expansion.

 

CystoSmart, an AI tool designed to detect bladder tumors during screening and surveillance cystoscopy, is brand-agnostic and works with flexible, rigid, and single-use scopes. The software is intended for use with standard white light cystoscopy, assisting clinicians in improving tumor detection both in real-time and during post-procedure review.

 

The HSA approval comes just eleven months after CystoSmart received clearance from Brazil’s ANVISA regulator and positions the device for faster approval in Australia, Canada, Switzerland, and the United Kingdom through the Access Consortium.

 

Bladder cancer ranks as the tenth most common cancer globally and the sixth most frequent malignancy in men. The disease has a high recurrence rate—up to 80%—necessitating repeated monitoring. While white light cystoscopy remains the standard method for detection, studies show it misses 10% to 20% of tumors.

 

Dr Rajesh Nair, Chief Surgical Officer at ISC, said, “Early identification of cancer translates to improved clinical outcomes, impacting positively on the patient journey and overall health economy. 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 utilisation.”

 

He added, “CystoSmart can be used as an aid for urologists to improve detection accuracy: to reduce missed tumors and reduce unnecessary invasive biopsies and interventions.”

 

Clinical evaluations show that CystoSmart achieves over 95% sensitivity and 98% specificity in bladder tumor detection, helping clinicians improve diagnostic accuracy and patient care.