Lunit Inc. is the latest South Korean firm to gain the U.S. FDA’s 510(k) clearance for Lunit Insight DBT, its artificial intelligence (AI)-powered breast cancer diagnostic tool that analyzes digital breast tomosynthesis (DBT) images, boosting its efforts to enter the U.S. market. The company also reported that it secured $150 million in a public offering.

Lunit Inc. has won FDA approvals for the company’s breast cancer detection product Lunit Insight MMG and the triage and notification software Lunit Insight CXR Triage, only days apart. Lunit Insight MMG is an artificial intelligence (AI) product for breast cancer detection from mammography images. Lunit’s second approval is for Lunit Insight CXR Triage, its AI-powered chest X-ray triaging product.

Fujifilm Holdings Corp. has bagged the Japanese Pharmaceuticals and Medical Devices Agency (PMDA)’s approval for CXR-AID, its artificial intelligence (AI) powered chest X-ray analysis system developed in collaboration with Lunit Inc.