Philips Elevate Plus AI ultrasound software cleared by FDA

Philips received FDA clearance for Elevate Plus, an AI-powered upgrade to its EPIQ/Elite ultrasound systems, featuring automated quantification tools for abdominal and OB/GYN imaging.

• FDA clearance announced for a suite of AI-driven tools intended to enhance workflow and measurement reproducibility.
• Automated features include Follicle, Fibroid, Renal, and Bladder Volume assessments, plus OB/GYN tools like fetal biometry.
• Clearance was based on 510(k) pathway; specific agreement/performance metrics were not detailed in the announcement.

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