GE HealthCare secures 510(k) for updated Voluson Expert ultrasound

AuntMinnie.com staff writers
Jan 28, 2025

GE HealthCare (GEHC) has secured U.S. Food and Drug Administration (FDA) 510(k) clearance for its updated portfolio of Voluson Expert Series ultrasound systems.

The latest tools include SonoLystlive, which can be used during 11- to 14-week gestational anatomical exams, and an expanded color Doppler offering, Graphicflow, for visualizing complex blood flow in differentiating normal from abnormal hemodynamics.

GEHC also noted enhancements to select Voluson AI tools, including SonoPelvicFloor3.0, which helps reduce pelvic floor measurement exam time by automating plane alignment, live C-plane tracking, and measurements, and SonoAVCfollicle2.0, which uses AI in follicle detection.

The Voluson Expert Series integrates AI-powered features and automation tools in women's imaging, particularly complex, high-risk pregnancies, according to GEHC. The systems are designed to be compatible with specialty probes, including the 2D/3D probe RAB7-D and wireless Vscan Air dual probes, GE said.

GE HealthCare
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(A,B) Images from an initial ultrasound examination showed no identifiable lesions and received a consensus ultrasound category of US-1. Nearly the entire liver is visualized, with minimal shadowing (“s”, A and B), and the examination received consensus result of VIS-A. The AFP level was 7.1 ng/mL on assessment six months before the ultrasound, 9.1 ng/mL on assessment three months before examination, and 14.2 ng/mL on assessment on exam day. The AFP result was thus assessed as positive based on a progressive increase on two consecutive tests. The atient was considered to have negative surveillance result according to LI-RADS Ultrasound Surveillance v2017, but positive surveillance result according to LI-RADS Ultrasound Surveillance v2024. (C-D) Axial arterial-phase (C) and portal-venous phase (D) T1-weighted images from subsequent gadoxetic acid-enhanced MRI show a 2-cm arterial-phase hyperenhancing observation (arrow, C) with portal-venous washout (arrow, D) in segment 7. This observation was classified on MRI as LR-5, thus meeting the present study’s reference standard for diagnosis of HCC. The mass is located in the periphery of the liver, an anatomic area where ultrasound visualization can be challenging due to shadowing.
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Images depict a 49-year-old female participant with cryptogenic cirrhosis who presented with a 3.2-cm liver lesion. This biopsy-confirmed hepatocellular carcinoma (HCC) with an initial categorization of Liver Imaging Reporting and Data System (LI-RADS) category LR-4 (probably HCC) at CT was upgraded to LR-5 (definitely HCC) at contrast-enhanced ultrasound (CEUS). (A) Precontrast CT images in the liver show vague hypoattenuation in the medial left hepatic lobe (arrows). (B) Arterial phase images demonstrate no definite arterial phase hyperenhancement (arrows). (C) Washout and an enhancing capsule (arrows) on a late-phase image resulted in an LR-4 categorization. (D) B-mode ultrasound shows a round hypoechoic nodule (arrows). (E) An early-phase CEUS image shows clear arterial-phase hyperenhancement (arrows); (F) No washout at one minute (arrows), and (G) late, mild washout at four minutes (arrows) resulted in a CEUS LR-5 categorization.
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(A,B) Images from an initial ultrasound examination showed no identifiable lesions and received a consensus ultrasound category of US-1. Nearly the entire liver is visualized, with minimal shadowing (“s”, A and B), and the examination received consensus result of VIS-A. The AFP level was 7.1 ng/mL on assessment six months before the ultrasound, 9.1 ng/mL on assessment three months before examination, and 14.2 ng/mL on assessment on exam day. The AFP result was thus assessed as positive based on a progressive increase on two consecutive tests. The atient was considered to have negative surveillance result according to LI-RADS Ultrasound Surveillance v2017, but positive surveillance result according to LI-RADS Ultrasound Surveillance v2024. (C-D) Axial arterial-phase (C) and portal-venous phase (D) T1-weighted images from subsequent gadoxetic acid-enhanced MRI show a 2-cm arterial-phase hyperenhancing observation (arrow, C) with portal-venous washout (arrow, D) in segment 7. This observation was classified on MRI as LR-5, thus meeting the present study’s reference standard for diagnosis of HCC. The mass is located in the periphery of the liver, an anatomic area where ultrasound visualization can be challenging due to shadowing.
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(A,B) Images from an initial ultrasound examination showed no identifiable lesions and received a consensus ultrasound category of US-1. Nearly the entire liver is visualized, with minimal shadowing (“s”, A and B), and the examination received consensus result of VIS-A. The AFP level was 7.1 ng/mL on assessment six months before the ultrasound, 9.1 ng/mL on assessment three months before examination, and 14.2 ng/mL on assessment on exam day. The AFP result was thus assessed as positive based on a progressive increase on two consecutive tests. The atient was considered to have negative surveillance result according to LI-RADS Ultrasound Surveillance v2017, but positive surveillance result according to LI-RADS Ultrasound Surveillance v2024. (C-D) Axial arterial-phase (C) and portal-venous phase (D) T1-weighted images from subsequent gadoxetic acid-enhanced MRI show a 2-cm arterial-phase hyperenhancing observation (arrow, C) with portal-venous washout (arrow, D) in segment 7. This observation was classified on MRI as LR-5, thus meeting the present study’s reference standard for diagnosis of HCC. The mass is located in the periphery of the liver, an anatomic area where ultrasound visualization can be challenging due to shadowing.
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