Subtle Medical has secured 510(k) clearance from the U.S. Food and Drug Administration (FDA) for SubtleHD(CT), an AI-powered image enhancement software for CT imaging.
The software reduces noise and improves low-contrast detectability across CT scanner generations, according to the company. It is designed to integrate into existing workflows without requiring hardware changes, Subtle Medical said.
SubtleHD(CT) is the company's first CT product and its eleventh FDA-cleared product overall, expanding a portfolio that already includes AI image enhancement software for MRI and PET across more than 1,300 scanners worldwide, according to the company.
