Intelligent Scopes Corp (ISC) has received regulatory clearance from the Health Sciences Authority (HSA) in Singapore for its AI software tool, CystoSmart™, which aids in detecting bladder tumours during endoscopic bladder examinations.
- Technical Performance: Clinical evaluations report a sensitivity of over 95% and a specificity exceeding 98% for bladder tumour detection.
- Compatibility: The brand-agnostic software functions with both flexible and rigid cystoscopes, supporting clinicians in real-time and post-processing modes.
- Strategic Impact: The HSA clearance for CystoSmart can help support regulatory recognition in other Access Consortium jurisdictions, such as Australia, Canada, Switzerland and the United Kingdom.
This summary is based on a press release published on BioSpectrum Asia.