Philips said on June 2 that the FDA granted 510(k) clearance for Elevate Plus, a software upgrade for its EPIQ Elite and Affiniti general-imaging ultrasound systems. The shift is less about pixels than about where the AI lives: the company is moving its Koios decision-support engine onto the scanner itself, so the read happens at the cart rather than on a separate workstation.
Two features anchor the release. Auto Measure Abdomen automates routine abdominal measurement steps, which Philips says deliver “over 93% accuracy compared to manual measurements by clinical experts.” And Koios AI, now available on-cart, brings decision support to breast and thyroid imaging. Per the company, the breast tool — Koios Bi-RADS — “offers interpretation and assessment of the risk of malignancy in under 2 seconds”; the thyroid tool, Koios Ti-RADS, is described as supporting “confident lesion classifications using over 350,000 pathology-proven cases.” (BI-RADS and TI-RADS are the standard radiology scoring systems for breast and thyroid imaging that those tool names reference.) The under-two-second figure is attached only to the breast pathway in Philips’ own wording, not to thyroid. The upgrade also bundles imaging refinements branded XRes Pro+ and Super Res MVI Pro.
The numbers carry caveats
The 93% accuracy figure is not unsupported, but the evidence behind it is thin. A footnote in the release says the number was “obtained from a retrospective data analysis study involving data from 150 subjects (using MD.AI annotation tool, 3 clinical experts).” That is a small, internal, retrospective comparison against three expert annotators — not a peer-reviewed or prospective trial.
The most quotable figure — an up-to-30% reduction in scanning time — rests on even less. It comes from a testimonial attributed to Gretchen Sammy, an ultrasound manager at Boston Medical Center, in the company’s release: “Automating key measurement tasks allows our sonographers to reduce scanning time by up to 30% without sacrificing clinical precision.” That is a single-site customer statement about automating measurement tasks in general — the release does not tie the 30% to any one named feature — and it is not a controlled study. Philips has posted no trial behind it.
A 510(k) clearance establishes substantial equivalence to a predicate device; it is not evidence that the AI improves patient outcomes.
For now, Elevate Plus is a workflow-and-triage story: faster measurements and on-cart decision support meant to standardize how sonographers flag breast and thyroid findings. The release makes no patient-outcome or clinical-benefit claim. Whether the tool translates into fewer missed lesions or shorter reporting cycles is a question the marketing materials cannot answer.