U-Systems' somo.v nets Canadian license

AuntMinnie.com staff writers
Aug 15, 2011

Ultrasound developer U-Systems has received a medical device license from the Medical Devices Bureau of Health Canada to sell and market its somo.v automated breast ultrasound (ABUS) system as an adjunct to mammography for screening asymptomatic women for breast cancer in Canada.

The license approves somo.v for use as an adjunct to mammography to provide physicians with enhanced sensitivity for breast cancer detection in diagnostic symptomatic and screening asymptomatic women, according to U-Systems.

In addition to Canada, somo.v is approved for breast cancer screening in the 27 European Union countries. The device also has received clearance by the U.S. Food and Drug Administration (FDA) for adjunctive diagnostic use with mammography in the U.S.

Latest in Breast
Mri Breast 400
NME breast lesions have high malignancy rate on MRI-guided biopsy
August 10, 2026
(A) Free-response receiver operating characteristic (FROC) curve for DBT-DINO and DINOv2 (Meta AI) on the detection task. DINOv2 achieved higher sensitivity than DBT-DINO across most false-positive thresholds. (B) Detection rates of DBT-DINO and DINOv2 for lesions that were ultimately found to be benign (n = 70) and lesions that were found to be cancerous (n = 66). Error bars represent 95% CIs estimated via patient-level bootstrapping with 1000 repetitions. Both models showed similar detection rates for cancerous lesions, whereas DINOv2 detected more benign lesions than DBT-DINO. (C) Example bounding box predictions for DBT-DINO and DINOv2 on the detection test set. Each image is a single two-dimensional section from a three-dimensional digital breast tomosynthesis volume; the first column shows a mediolateral oblique view, and the second and third columns show craniocaudal views. Both models struggled to detect very small lesions, such as the 3-mm-diameter lesion shown in the first column. FP = false positive.
DBT-based foundational model classifies breast density
August 4, 2026
Rad Site
RadSite publishes clinical coverage guideline for breast CBCT imaging
July 30, 2026
Images in a 70-year-old asymptomatic woman with a prior excisional biopsy in the left breast yielding lobular carcinoma in situ 3 years earlier. Screening contrast-enhanced mammography (CEM) was performed, which was considered a prevalence screen as the woman had no prior breast MRI in the past 3 years and no prior CEM. (A) Low-energy (26–30 kVp) mediolateral oblique (MLO) and (B) craniocaudal (CC) views show surgical clips but no abnormality. (C) Recombined MLO and (D) CC images show an enhancing mass in the medial left breast (arrows). Biopsy revealed invasive lobular carcinoma. Size was 0.2 cm; tumor grade II/III; negative lymph nodes; and estrogen receptor–positive, progesterone receptor–positive, and human epidermal growth factor receptor 2–negative.
CEM finds breast cancer at baseline, incidence screening
July 28, 2026
Related Stories
2011 08 09 11 56 38 249 Stanford Breast Coil Image 02 Thumb
MRI
Stanford group shrinks MRI coil for better breast imaging
2011 07 29 08 17 13 510 2011 07 28 Bmj Thumb
Breast
Debate over breast screening to intensify after new BMJ study
2011 07 06 16 04 57 96 Li Mri Breast Thumb
MRI
CE-MRI predicts survival in breast cancer patients after chemo
2011 06 27 09 36 40 776 Sectra Mammography Unit Thumb
Breast
Sectra to sell mammography business to Philips
More in Breast
NME breast lesions have high malignancy rate on MRI-guided biopsy
By Amerigo Allegretto
Biopsies from women with a known ipsilateral malignancy have a higher frequency of breast cancer.
August 10, 2026
Mri Breast 400
DBT-based foundational model classifies breast density
By Amerigo Allegretto
DBT-DINO showed strong performance in classifying breast density from DBT images.
August 4, 2026
(A) Free-response receiver operating characteristic (FROC) curve for DBT-DINO and DINOv2 (Meta AI) on the detection task. DINOv2 achieved higher sensitivity than DBT-DINO across most false-positive thresholds. (B) Detection rates of DBT-DINO and DINOv2 for lesions that were ultimately found to be benign (n = 70) and lesions that were found to be cancerous (n = 66). Error bars represent 95% CIs estimated via patient-level bootstrapping with 1000 repetitions. Both models showed similar detection rates for cancerous lesions, whereas DINOv2 detected more benign lesions than DBT-DINO. (C) Example bounding box predictions for DBT-DINO and DINOv2 on the detection test set. Each image is a single two-dimensional section from a three-dimensional digital breast tomosynthesis volume; the first column shows a mediolateral oblique view, and the second and third columns show craniocaudal views. Both models struggled to detect very small lesions, such as the 3-mm-diameter lesion shown in the first column. FP = false positive.
RadSite publishes clinical coverage guideline for breast CBCT imaging
By AuntMinnie.com staff writers
The guide outlines how breast CBCT should be used when conventional imaging approaches are inconclusive or inaccessible.
July 30, 2026
Rad Site
CEM finds breast cancer at baseline, incidence screening
By Amerigo Allegretto
Incidence screening with CEM maintains high performance and may offer more benefits over baseline CEM screening.
July 28, 2026
Images in a 70-year-old asymptomatic woman with a prior excisional biopsy in the left breast yielding lobular carcinoma in situ 3 years earlier. Screening contrast-enhanced mammography (CEM) was performed, which was considered a prevalence screen as the woman had no prior breast MRI in the past 3 years and no prior CEM. (A) Low-energy (26–30 kVp) mediolateral oblique (MLO) and (B) craniocaudal (CC) views show surgical clips but no abnormality. (C) Recombined MLO and (D) CC images show an enhancing mass in the medial left breast (arrows). Biopsy revealed invasive lobular carcinoma. Size was 0.2 cm; tumor grade II/III; negative lymph nodes; and estrogen receptor–positive, progesterone receptor–positive, and human epidermal growth factor receptor 2–negative.
Women's Imaging MinnieCast, Episode 13: Partial breast irradiation in the spotlight
By Amerigo Allegretto
Two committee members for ASTRO's PBI guidelines share insights about this breast cancer treatment option.
July 17, 2026
Minnie Cast Thumbnail (15)
Incorrect AI suggestions influence reader performance on mammography
By Amerigo Allegretto
The biggest impact on reader performance stemmed from false-negative AI suggestions.
July 14, 2026
A normal mammogram confirmed by three-year radiologic follow-up illustrates reader-marked regions of interest (ROIs) during (A) unaided (round 1) and (B) artificial intelligence (AI)–assisted (round 2) reading. Each colored dot represents an ROI for recall by a human reader. Readers could mark more than one ROI per case, represented by multiple dots of the same color. During AI-assisted reading, the AI system displayed three visible prompts: two with suspicion of malignancy scores of 35% (left mediolateral oblique [L MLO] and craniocaudal [L CC]) and one with a suspicion of malignancy score of 10% (right craniocaudal [R CC]), shown as polygonal overlays. Without AI, six of 10 readers (60%) marked a false-positive ROI. With AI assistance, this fell to two of 10 (20%). R MLO = right mediolateral oblique.
Breast cancer screening higher among civically engaged women
By Amerigo Allegretto
Women who voted, attended a public meeting, or volunteered are more likely to get their breast cancer screening.
July 14, 2026
Mammogram Calendar 400
CEM on par with MRI for breast cancer diagnosis, local staging
By Amerigo Allegretto
CEM alone in a prospective study achieved perfect sensitivity and negative predictive value in diagnosing breast cancer.
July 10, 2026
MRI false positive for additional disease, (top to bottom): A. Index lesion—grade 2 invasive ductal carcinoma; B. MRI lesion two, upper inner quadrant: Stromal sclerosis and columnar cell change; C. MRI lesion three, upper outer quadrant: No ultrasound correlate, no malignancy on follow-up; D. CEM marked background parenchymal enhancement with a unifocal retroareolar lesion demonstrating wash-out on delayed MLO. Images are republished under a Creative Commons license (CC BY 4.0).
Siemens Healthineers gets FDA nod for CEM on Mammomat B.brilliant
By AuntMinnie.com staff writers
Siemens Healthineers has received FDA clearance for CEM and CEM biopsy capabilities for its Mammomat B.brilliant system.
June 30, 2026
Mammomat B.brilliant breast imaging system
Fujifilm, IAEA sign agreement to expand cancer imaging
By AuntMinnie.com staff writers
The two organizations will collaborate on awareness campaigns, education and training programs for healthcare professionals, and the provision of Fujifilm medical equipment.
June 29, 2026
Acquisitions
DeepHealth gets FDA nod for two mammography AI tools
By AuntMinnie.com staff writers
DeepHealth has received FDA clearance for two parts of the company's Breast Suite AI platform: BAC Assessment and Mammo Dx.
June 25, 2026
Deephealth White On Purple
QT Imaging reports low variability for breast scanner biomarkers
By AuntMinnie.com staff writers
Study analyzes Breast Acoustic CT speed-of-sound (SoS) measurements.
June 24, 2026
Breast Update 2 T76 Vuzvgq
Page 1 of 584
Next Page