Philips Secures FDA 510(k) Clearance for its AI Suite Elevate Plus
Philips announced on Tuesday that it has received FDA 510(k) clearance for Elevate Plus, an AI and automation suite for the EPIQ Elite and Affiniti ultrasound systems, aimed at standardizing examinations and reducing repeat scans. This development strengthens the Dutch group's position in AI-assisted medical imaging.
AI Automation to Standardize Ultrasound Examinations
Elevate Plus combines advanced imaging with workflow automation features. Auto Measure Abdomen, one of the main components, uses AI to automate common measurement steps, reducing variability among users and decreasing examination time. According to presented data, the measurements provided by this function show an accuracy over 93% compared to manual measurements performed by clinical experts. The Koios AI function, previously only available outside the devices, is now integrated directly into EPIQ Elite and Affiniti, enabling classification of breast lesions and thyroid nodules. Integration with Koios Bi-RADs offers interpretation and malignancy risk assessment in less than 2 seconds.
Image Quality Enhancements for More Reliable Diagnostics
Elevate Plus introduces imaging enhancements designed to facilitate the visualization of anatomical structures and blood flows, particularly in challenging examinations. XRes Pro+ offers improved tissue detail definition and sharper contours. Super Res MVI Pro enhances the visualization of microvascular flow, providing a clearer view of blood flow and promoting more efficient examinations with fewer repetitions.
Modular and Scalable Architecture for System Sustainability
EPIQ Elite and Affiniti Elevate Plus are based on a modular and scalable architecture that allows adaptation to future developments. The release emphasizes that remote updates and security enhancements keep the technology up-to-date with minimal disruption, while integrated telehealth support promotes consistency across teams and care sites.
