Intelligent Scopes Corp (ISC) has received regulatory clearance from Singapore’s Health Sciences Authority (HSA) for CystoSmart, its AI software for bladder tumour detection.
The software is designed to assist clinicians during endoscopic bladder examinations and is compatible with both rigid and flexible scopes, including single-use devices.
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It operates with white light cystoscopy to support detection accuracy in real-time and through post-processing.
The HSA clearance follows approval by Brazil’s Agência Nacional de Vigilância Sanitária (ANVISA) 11 months earlier. This authorisation supports CystoSmart’s entry into Singapore and facilitates accelerated regulatory processes in Canada, Australia, the UK, and Switzerland through the Access Consortium collaboration.
Clinical and technical evaluations of CystoSmart report a sensitivity (true positive rate) exceeding 95% and a specificity (true negative rate) exceeding 98% in detecting bladder tumours. The technology aims to help clinicians improve diagnostic accuracy during cystoscopy procedures.
ISC chief surgical officer Dr Rajesh Nair 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.
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By GlobalData“Early detection or exclusion of bladder cancer allows for more effective resource utilisation. CystoSmart can be used as an aid for urologists to improve detection accuracy: to reduce missed tumours and reduce unnecessary invasive biopsies and interventions.”
ISC operates as a subsidiary of Claritas HealthTech and develops medical devices featuring AI diagnostic tools, image processing, and enhancement software for gastroenterology and urology.
Its focus areas include robotic guidance systems, image enhancement, and improving outcomes by reducing unnecessary biopsies in endoscopy.
