FDA Clears AI-Powered Software for Improving Low-Contrast CT Detection

The Food and Drug Administration (FDA) has granted 510(k) clearance for SubtleHD(CT), an emerging AI software for bolstering image quality for computed tomography (CT) scans.

The 11^th Subtle Medical product to garner FDA clearance, SubtleHD(CT) enables enhanced image quality and noise reduction across different CT scanners, according to Subtle Medical.

The company maintained that SubtleHD(CT) addresses a key need amid rising imaging volume demand and facilities seeking consistent quality with a diverse array of CT scanners, some of which may be older models.

“Health-care organizations are looking for ways to improve imaging performance while maximizing the value of the infrastructure they already have,” said Ohad Arazi, the chief executive officer of Subtle Medical. “With SubtleHD(CT), we're extending our expertise in AI-powered image enhancement to CT and taking another step toward our vision of helping providers enhance image quality across the imaging enterprise.”