Philips Secures FDA Clearance for AI-Enhanced Ultrasound Systems

Royal Philips has announced that it secured FDA 510(k) clearance in the United States for its Elevate Plus offering, which incorporates artificial intelligence into its EPIQ Elite and Affiniti ultrasound systems. This development aims to bolster efficiencies in general imaging by introducing advancements in AI-driven automation and imaging.

Elevate Plus is designed to standardize routine ultrasound exams, mitigate variances across different users, and diminish the necessity for repeat scans. By enhancing workflow automation, the system strives to deliver high-quality, consistent images more rapidly, supporting clinical teams facing increasing patient loads and staffing constraints.

Jie Xue, Chief Business Leader of Precision Diagnosis, Philips, highlighted the innovation's potential to enhance care delivery: "By combining intelligent imaging with AI-powered workflow automation, Elevate Plus is designed to reduce variability, streamline routine exams, and support faster, more informed clinical decisions."

One of the central features of Elevate Plus is its Auto Measure Abdomen function. This tool employs AI to automate routine measurement processes, substantially cutting down on time-intensive and operator-dependent tasks. Clinical evaluations revealed that automated measurements boast over 93% accuracy, closely mirroring the assessments of expert operatives.

Elevate Plus also integrates Koios AI decision support into the ultrasound system. Previously available only off-cart, this feature assists clinicians in efficiently classifying breast lesions and thyroid nodules, offering risk assessments with notable speed and accuracy.

Advanced enhancements in imaging quality, such as XRes Pro+, aim to provide sharper and cleaner imaging details, while Super Res MVI Pro is designed to deliver more precise visualization of microvascular flow. These features collectively aim to aid clinicians in accessing clearer insights and enhancing diagnostic efficiency, ultimately reducing the need for repeated scans.

The ultrasound systems equipped with Elevate Plus are constructed for longevity, incorporating a modular design that facilitates future upgrades and includes built-in tele-health functionalities. This ensures evolving demands can be met without substantial overhauls, thereby extending the system's lifespan and utility.

According to Maria Cristina Chammas, Director of the Ultrasound Division at the Hospital das Clínicas, School of Medicine, University of São Paulo, the system holds potential to significantly streamline workflow and diminish sonographer fatigue by automating repetitive tasks while upholding clinical accuracy.