The Tamesis
Intelligent Scopes Corp has received the regulatory green light for its new bladder cancer software.
The growing focus on advanced imaging and diagnostic solutions is driving Singapore’s medical device industry to integrate artificial intelligence (AI) into daily clinical practice.
A report by GlobalData said the industry’s growth is in line with the country’s goal of a “future-proof” healthcare system that is capable of meeting growing demand and complexity.
In a key development, US medical technology company Intelligent Scopes Corp has received regulatory approval from the Health Sciences Agency (HSA) for its artificial intelligence software tool CystoSmart, which supports bladder cancer detection.
The tool analyzes cystoscopy images to help clinicians detect and characterize lesions, reducing variability in interpretation while leaving the final decision to the clinician.
The approval comes as Singapore and Malaysia launch the Medical Device Regulatory Dependency Scheme, a six-month pilot program running until February 28 that aims to shorten the approval time for selected medical devices.
Under the scheme, HSA Singapore and the Medical Devices Authority of Malaysia can rely on each other’s regulatory assessments of medium and high risk devices (covering categories B, C and D).
According to Singapore’s comprehensive assessment route, the review time for Class B equipment takes up to 160 working days, Class C equipment takes 220 days, and Class D equipment takes up to 310 days.
While the pilot is expected to attract more funding from venture funds, private equity firms and investors, analysts noted that its short duration could limit uptake as companies typically plan their strategies in three- to five-year cycles.
“Singapore’s digital health landscape is increasingly shaped by structured oversight and practical implementation,” said Anindita Ghosh, medical devices analyst at GlobalData. “This enables digital health solutions to be used more reliably across Singapore’s healthcare system.”
Ghosh added that AI-based software enables faster and more consistent interpretation of medical images, reduces diagnostic variability, improves workflow and aids clinical decision-making, while still relying on clinician oversight for final evaluation.
Domestically, National University Health System (NUHS) is partnering with Genesis MedTech Group to develop a surgical AI project and hiring NUHS clinicians to support product development that meets clinical needs.
The two organizations will also set up the “Genesis-NUHS Artificial Intelligence Innovation and Surgical Training Laboratory.”
Separately, the Singapore-MIT Research and Technology Alliance has established a research center to develop wearable ultrasound imaging systems for real-time monitoring of chronic diseases.
