Philips receives FDA 510(k) clearance for Elevate Plus for EPIQ Elite and Affiniti, delivering AI advancements in general imaging ultrasound

June 2, 2026  Philips receives FDA 510(k) clearance for Elevate Plus for EPIQ Elite and Affiniti, delivering AI advancements in general imaging ultrasound AI-powered workflow automation helps clinicians acquire high-quality reproducible images faster and with greater confidence Amsterdam, the Netherlands – Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, today announced regulatory clearance in the USA of Elevate Plus, bringing advanced imaging and a suite of AI and automation capabilities to Philips EPIQ Elite and Affiniti, its flagship ultrasound systems. With CE Mark and 510(k) clearance, Elevate Plus helps standardize routine exams and reduce the need for repeat scanning, delivering more consistent and high-quality ultrasound images faster across users.