Koninklijke Philips N.V. (PHG), a health technology company, announced on Monday that the U.S. Food and Drug Administration, or FDA, has granted clearance for Elevate Plus, an advanced AI imaging system designed for its flagship ultrasound systems, the Philips EPIQ Elite and Affiniti.
Elevate Plus is cleared under CE marking in Europe and FDA 510(k) clearance in the U.S and it aims to standardise routine check-ups, reduce the need for rescanning, and deliver consistent, high-quality ultrasound images, the firm noted.
Additionally, the auto-measure abdomen feature in Elevate Plus is designed to perform routine abdominal measurements with minimal variability and an accuracy of over 93% in high-volume settings.
The company obtained the data results for Elevate Plus from 150 subjects using the MD.AI annotation tool and 3 clinical experts.
On the other hand, Koios AI decision support, which was previously available off-cart, is now accessible on-cart for EPIQ Elite and Affiniti ultrasound systems. This enhancement allows clinicians to classify breast lesions and thyroid nodules more effectively.
EPIQ Elite and Affiniti Elevate Plus are designed to deliver extended-life systems through modular, upgradable platforms to minimise disruptions and promote consistency across care teams, Philips stated.
Moving forward, the company expects to expand its leadership in AI-powered ultrasound to address high demand for care teams and staffing pressures.
PHG is currently trading at $25.37, down 0.24%.
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