Philips has secured 510(k) clearance from the U.S. Food and Drug Administration (FDA) for Elevate Plus, an AI-powered software suite for its Epiq Elite and Affiniti ultrasound systems.
The FDA clearance includes Auto Measure Abdomen, for automating routine measurement steps and reducing scanning time, the company noted, adding that the software is designed to reduce variability.
In addition, the company highlighted in-cart integration of Koios AI decision support aids for classifying breast lesions and thyroid nodules using the Koios Bi-RADS risk-of-malignancy assessment and Koios Ti-RADS software which has been trained on more than 350,000 pathology-proven cases.
The company also noted the XRes Pro+ software, which is designed to improve tissue detail and boundary sharpness across patient body types, and Super Res MVI Pro, which is designed to enhance microvascular flow visualization.
Elevate Plus is now both FDA-cleared and CE-marked, according to the company.
