Philips Elevate Plus gains FDA clearance for ultrasound AI
Elevate Plus for EPIQ Elite and Affiniti includes Auto Measure Abdomen, Koios decision-support integration, and image-quality tools for general imaging ultrasound.
Philips has received U.S. FDA 510(k) clearance for Elevate Plus on its EPIQ Elite and Affiniti ultrasound systems, adding AI and automation features for general imaging ultrasound.
The FDA 510(k) summary specifically describes the addition of Auto Measure Abdomen to Philips EPIQ and Affiniti diagnostic ultrasound systems. The software is designed to automate selected measurements used in routine abdominal and renal exams.
Auto Measure Abdomen provides semi-automated, editable measurements for abdominal organs such as the kidney and spleen. Users can adjust caliper endpoints or perform additional manual measurements.
The cleared feature is available with C5-1 and C9-2 transducers only. FDA records state that the software is supported by EPIQ and Affiniti models running software version 14.0 or higher.
Philips said Auto Measure Abdomen achieved more than 93% accuracy compared with manual measurements by clinical experts. The company said the figure came from a retrospective data analysis involving 150 subjects and 3 clinical experts.
The FDA summary said the validation study evaluated kidney sagittal length, kidney transverse width, kidney transverse height, and spleen length. The proposed device did not require clinical studies to support substantial equivalence.
Elevate Plus also includes in-cart integration of Koios AI decision-support tools for breast lesion and thyroid nodule classification, according to Philips. The company said the Koios tools use Bi-RADS and Ti-RADS software trained on more than 350,000 pathology-proven cases.
Additional Elevate Plus features include XRes Pro+ for tissue detail and boundary sharpness, and Super Res MVI Pro for microvascular flow visualization. Philips said the suite is now both FDA-cleared and CE-marked.
Companies:Philips, Koios Medical, U.S. Food and Drug Administration
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