Lunit, a provider of artificial intelligence-powered cancer solutions, said Monday that it has received approval from the European Union for the commercial launch of its AI-based medical software used in detecting breast cancer.
The solution, dubbed Lunit Insight Digital Breast Tomosynthesis, is an AI-based software solution to help identify suspicious lesions with 3D mammograms.
“(Lunit) has laid the groundwork for sales in European countries by earning the CE marking in around one month after the company received an export license from the Ministry of Food and Drug Safety here,” Lunit CEO Seo Beom-seok said.
The EU currently requires the European Medical Devices Regulation CE Marking for commercializing medical devices. Those medical devices that previously received a CE marking under the Medical Devices Directive are currently asked to be recertified by May 2024 in line with the updated CE MDR regulation.
Lunit said it will soon launch Lunit Insight DBT in Europe. “Lunit will try to begin sales of the solution, starting with major countries in the EU,” an official from the company said.
The company also plans to obtain regulatory approval in the other foreign markets where the company sees increasing demand for similar AI-powered tools.
According to Lunit, demand for such 3D image analysis tools has been increasing in the global market, as they are more accurate than existing tools for 2D images.
Of many countries, Lunit expected Australia to become the next country for it to receive regulatory approval, as the country’s regulations regarding medical devices are similar to those in Europe.
Seo said, “As Lunit Insight DBT has met newly updated and stricter requirements of Europe, the company expects to receive regulatory approvals in other countries in succession, including, the US and Australia.”
Lunit currently has two other AI-powered solutions that have received updated regulatory approval in Europe: Lunit Insight CXR, an AI solution for chest X-rays, and Lunit Insight MMG, also an AI solution for mammography.
To date, Lunit has provided Lunit Insight CXR and MMG at around 1,000 medical sites across more than 40 countries, the company added.