Intelligent Scopes Corp (ISC), specialising in state-of-the-art image enhancement and precision AI software solutions for urology and gastroenterology, announces that CystoSmart has received regulatory clearance from Health Sciences Authority (HSA), the National Regulatory Agency for medical products and devices in Singapore.
CystoSmart, an AI software tool for bladder tumour detection in patients undergoing screening and surveillance endoscopic examination of the bladder, is brand agnostic and compatible with flexible and rigid scopes, including single-use scopes. The device is intended to be used with white light cystoscopy to aid clinicians in improving the detection accuracy of bladder tumours in real-time and post-processing conditions.
The HSA clearance for CystoSmart, which comes eleven months after it was approved by ANVISA, the Brazilian medical devices regulator, marks a significant milestone. 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 per cent), requiring repeated follow-up examinations. White light cystoscopy is the standard and most widely used method for bladder tumour detection and surveillance; however, as per published studies, between 10 per cent and 20 per cent of bladder tumours are regularly missed by standard white light cystoscopy.
Dr Rajesh Nair, Chief Surgical Officer of ISC, commented, “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 tumours and reduce unnecessary invasive biopsies and interventions.”
As per clinical and technical evaluations conducted, CystoSmart has a sensitivity (true positive rate) of over 95 per cent and a specificity (true negative rate) of over 98 per cent in bladder tumour detection, thereby aiding clinicians to improve accuracy.
