On-device AI delivers results in five seconds with 98% sensitivity (Scientific Reports, 2024)
Dr. CerviCARE® AI, winner of the CES 2026 Innovation Award
NTL HEALTHCARE announced that its on-device AI cervical cancer screening system, Dr.CerviCAREon, has received Class III medical device approval from South Korea's Ministry of Food and Drug Safety (MFDS). The device is the first in the OB/GYN field to receive approval as an embedded, on-device AI diagnostic under the country's Digital Medical Products Act, which took effect inJanuary 2025.
Conventional AI-based diagnostic software has typically relied on server or cloud connectivity — a dependency that NTL HEALTHCARE's on-device system eliminates entirely. The device embeds the AI engine directly into the medical camera hardware, offering three key advantages: On-device processing — the system performs advanced image analysis without any external network connection; Data security — patient data remains entirely on the device, eliminating the risk of transmission to external servers; Five-second turnaround — cervical cancer staging results are delivered in approximately five seconds, enabling immediate point-of-care decision-making even in fully offline environments.
The AI software powering the device, CerviCARE® AI, has demonstrated diagnostic accuracy comparable to that of tertiary-level medical institutions, despite being designed for point-of-care use. The system achieved a sensitivity of 98% for high-grade lesions, according to a study published in Scientific Reports (2024), an SCI-indexed peer-reviewed journal. The technology was also recognized with a CES 2026 Innovation Award in the Artificial Intelligence category.
NTL HEALTHCARE is directing its efforts toward low- and middle-income countries (LMICs) and medically underserved regions where screening infrastructure is limited. The device's independence from stable network or power supply makes it deployable in remote areas where hospital-level diagnostics have traditionally been out of reach. The company is currently collaborating with international organizations across Asia, Africa, Latin America, and Eastern Europe to expand distribution, describing the initiative as a step toward "democratizing digital healthcare."
"The Class III approval of our on-device AI diagnostic system, along with the CES Innovation Award, demonstrates that NTL's AI technology is at the forefront of the global market," said Taehee Kim, CEO of NTL HEALTHCARE. "We will continue working to close gaps in medical access and advance public health equity worldwide."
Choi Mun-hee
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