In a major step forward for AI-powered healthcare solutions, the U.S. Food and Drug Administration (FDA) granted approval in June 2025 to Allix5, an artificial intelligence software developed by Clarity, for predicting the five-year risk of developing breast cancer. Allix5 analyzes mammography images to deliver a quantified forecast of cancer risk, marking a milestone in preventive medicine and the growing role of AI diagnostics in healthcare.
With the FDA’s green light, experts anticipate a significant acceleration in the adoption of AI in medical markets. As healthcare systems worldwide pivot from treatment-focused models to prevention-centered strategies, tools like Allix5 are expected to play a pivotal role in early detection and risk assessment, offering both medical and economic value.
Lunit's “Insight Risk” Joins the AI Race in Breast Cancer Prediction
Although Clarity’s Allix5 reached the market first, South Korean med-tech company Lunit is preparing to launch a similar AI solution. Lunit unveiled its “Lunit Insight Risk” platform at the 2024 Radiological Society of North America (RSNA) meeting. The software analyzes mammograms to assess the risk of developing breast cancer within one to five years.
Unlike previous statistical tools, Insight Risk uses a big data-based model that considers individual patient characteristics, including ethnicity and medical history, enabling personalized diagnostics. Moreover, with its acquisition of AI software firm Blapha, Lunit now offers a comprehensive AI solution covering the full patient care cycle—from initial screening to discharge.
"Our strength lies in combining predictive analytics with total care integration," said a Lunit representative. "This creates a framework not only for diagnosis but also for customized treatment pathways."
VUNO Targets Sudden Cardiac Arrest With DeepCARS
Another key player, VUNO, is currently pursuing FDA approval for its AI-based sudden cardiac arrest prediction tool, VUNO Med–DeepCARS, targeting a Q3 authorization. The product received CE MDR certification in Europe and UKCA approval in May 2025. With backing from clinical partners in the EU and UK, VUNO is now negotiating insurance reimbursement policies ahead of an official market entry scheduled for the first half of 2026.
In the U.S., VUNO is buoyed by its prior designation as an FDA Breakthrough Device (BDD), increasing confidence in a smooth approval process.
3billion Aims at Rare Diseases With AI-Powered Genetic Testing
Meanwhile, 3billion, another South Korean startup, is focused on rare disease diagnostics using AI to interpret massive volumes of genetic data. The company's proprietary platform can analyze over 100,000 genetic variants in under five minutes with a 99.4% accuracy rate, giving new hope to patients with undiagnosed conditions.
"About 90% of known rare genetic disorders still lack targeted treatments," a company spokesperson said. "Our core strength is in detecting the undetected, which opens doors to new drug discovery pipelines."
3billion is accelerating its expansion into the biopharma space, leveraging its diagnostics to contribute to the development of novel therapeutics.
Outlook: Can Korean AI Healthcare Stay Competitive Globally?
The recent FDA approval of Allix5 signals the beginning of a new era for Korean AI in healthcare. Startups like Lunit, VUNO, and 3billion are not only bringing competitive solutions to global markets but also reshaping the conversation around AI-enabled preventive care, early diagnosis, and precision medicine.
As more Korean med-tech companies enter the international stage, the hope is that their AI-driven innovations will carve out a lasting presence in the global healthcare ecosystem.
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