{"entity":{"id":"automated-breast-ultrasound","kind":"technology","name":"Automated breast ultrasound (Invenia ABUS) and ultrasound tomography (SoftVue)","aka":["ABUS","Automated breast ultrasound","3D breast ultrasound","Invenia ABUS","SOMO.V","SoftVue","Whole-breast ultrasound tomography"],"tldr":"A breast ultrasound done by a machine that sweeps the whole breast in a few passes, used alongside mammograms in women with dense breasts. It finds extra cancers but also leads to more call-backs for things that turn out not to be cancer.","summary":"Automated breast ultrasound is a class III device in the United States (product code PAA). GE Healthcare's SOMO.V ABUS was approved on 18 September 2012 (P110006), with later Invenia ABUS supplements; Delphinus Medical Technologies' SoftVue automated whole breast ultrasound system was approved on 6 October 2021 (P200040). In the SomoInsight study of 15,318 women with dense breasts, adding automated ultrasound to screening mammography found 1.9 additional cancers per 1,000 women screened (112 cancers in all, 30 of them found only by ultrasound, 93.3 per cent of those invasive), but recalls rose by 284.9 per 1,000 women; the authors concluded that it \"increased the cancer detection yield of clinically important cancers, but it also increased the number of false-positive results\".","status":"established","asOf":"2026-11-04","links":[{"label":"FDA PMA P110006: SOMO.V ABUS automated breast ultrasound (18 September 2012)","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P110006"},{"label":"FDA PMA P200040: SoftVue automated whole breast ultrasound (6 October 2021)","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P200040"},{"label":"FDA product code PAA: automated breast ultrasound","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm?ID=PAA"},{"label":"Brem et al., the SomoInsight study of automated breast ultrasound in dense breasts (Radiology 2015)","url":"https://doi.org/10.1148/radiol.14132832"}],"tags":["devices-gaps-2026-11"],"related":[],"cancers":["breast-cancer"],"sections":["early-detection","imaging","devices"],"technologies":["ultrasound","mammography","breast-mri-coils-abbreviated-mri","vacuum-assisted-breast-biopsy"],"targets":[],"drugs":[],"companies":["ge-healthcare"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"provenance":{"editedBy":"OnCo device gap fill (openFDA, accessdata.fda.gov, NICE, Europe PMC, maker pages)","editedOn":"2026-11-04"},"principle":"A wide transducer on a compression paddle, or a ring transducer around the breast, sweeps it automatically, producing a three-dimensional volume that a radiologist reads separately from the acquisition.","strengths":["Finds additional invasive cancers in dense breasts","Standardised acquisition by a technologist"],"limitations":["Many more recalls and biopsies for benign findings","Does not replace mammography"],"since":2012},"route":"/technologies/automated-breast-ultrasound/","neighbours":{"cancer":[{"id":"breast-cancer","kind":"cancer","name":"Breast cancer (all types)","route":"/cancers/breast-cancer/"}],"section":[{"id":"devices","kind":"section","name":"Devices & Physical Therapies","route":"/fronts/devices/"},{"id":"early-detection","kind":"section","name":"Early Detection & Screening","route":"/fronts/early-detection/"},{"id":"imaging","kind":"section","name":"Imaging","route":"/fronts/imaging/"}],"technology":[{"id":"breast-mri-coils-abbreviated-mri","kind":"technology","name":"Breast MRI coils and abbreviated breast MRI","route":"/technologies/breast-mri-coils-abbreviated-mri/"},{"id":"mammography","kind":"technology","name":"Mammography & tomosynthesis","route":"/technologies/mammography/"},{"id":"ultrasound","kind":"technology","name":"Ultrasound","route":"/technologies/ultrasound/"},{"id":"vacuum-assisted-breast-biopsy","kind":"technology","name":"Vacuum-assisted breast biopsy systems (Mammotome, EnCor, Eviva, Brevera)","route":"/technologies/vacuum-assisted-breast-biopsy/"}],"company":[{"id":"ge-healthcare","kind":"company","name":"GE HealthCare","route":"/companies/ge-healthcare/"}]}}