SonaCare lands FDA nod for HIFU system

AuntMinnie.com staff writers
Oct 13, 2015

High-intensity focused ultrasound (HIFU) developer SonaCare Medical has received U.S. Food and Drug Administration (FDA) clearance to market its Sonablate 450 system for the ablation of prostate tissue.

The firm said it expects to begin distributing the system in the U.S. in October. SonaCare previously received FDA clearance for its Sonatherm laparoscopic HIFU ablation device.

Latest in Ultrasound
Thyroid 400
RFA successful for treating malignant thyroid nodules
December 13, 2024
The clinical team perform an ultrasound scan at the Nyankunde Hospital, the Democratic Republic of the Congo, where Warren Cooper, MD, has performed operations ranging from repairing broken bones to craniotomies for over a decade.
What can we do to increase global access to imaging?
December 1, 2024
Digital Justice Scales
Inquest into neonatal death highlights ultrasound errors
November 27, 2024
Ultrasound Scanner Computerized 400 (1)
CEUS-based radiomics model aids in breast cancer diagnosis
November 26, 2024
Related Stories
2015 10 14 09 24 36 945 Radiation Symbol 200 New
Ultrasound
Ultrasound shows thyroid cancer spike after Fukushima
2015 10 08 15 34 19 856 Nguyen Larry 200
Ultrasound
ISO certification: Why it's important to you
2015 10 05 13 45 39 638 Hareendranathan Acetabular Model 200
Ultrasound
3D ultrasound-based hip segmentation is fast, accurate
2015 09 30 15 36 05 592 New Jersey 200
Ultrasound
Breast density law leads to higher ultrasound costs in NJ
More in Ultrasound
RFA successful for treating malignant thyroid nodules
By Amerigo Allegretto
Radiofrequency ablation (RFA) can successfully treat malignant thyroid nodules with minimal adverse events.
December 13, 2024
Thyroid 400
What can we do to increase global access to imaging?
By Josh Sokol, MD
Outreach and philanthropy will be central themes at RSNA 2024. Ahead of the congress, teleradiologist Josh Sokol, MD, explains why the radiology community must work together to improve access to imaging.
December 1, 2024
The clinical team perform an ultrasound scan at the Nyankunde Hospital, the Democratic Republic of the Congo, where Warren Cooper, MD, has performed operations ranging from repairing broken bones to craniotomies for over a decade.
Inquest into neonatal death highlights ultrasound errors
By Philip Ward
A radiologist and a sonographer failed to diagnose critical conditions in two pregnant women, including a twin baby who died three days after birth, a report has revealed.
November 27, 2024
Digital Justice Scales
CEUS-based radiomics model aids in breast cancer diagnosis
By Amerigo Allegretto
A contrast-enhanced ultrasound (CEUS)-based radiomics model could help accurately diagnose breast cancer.
November 26, 2024
Ultrasound Scanner Computerized 400 (1)
Ultrasound-based deep learning models aid thyroid nodule prediction
By Amerigo Allegretto
A deep learning-based framework incorporating ultrasound images and clinical data can help in thyroid nodule prediction.
November 25, 2024
Thyroid 400
Elastography shows tissue stiffness in athletes with low-back pain
By Amerigo Allegretto
Shear-wave elastography shows tissue stiffness in athletes with low-back pain, which could help guide rehabilitation strategies.
November 22, 2024
Back Pain 400
Nomogram model predicts malignancy risk in ovarian masses
By Amerigo Allegretto
A nomogram model based on O-RADS ultrasound findings and clinical and lab indicators can predict malignancy risk in adnexal cystic-solid masses.
November 19, 2024
Ovarian Cancer Social
AI-enabled CCTA on par with IVUS for plaque quantification
By Kate Madden Yee
An AI-powered automated plaque quantification tool for coronary CT angiography (CCTA) performs on par with intravascular ultrasound (IVUS) for quantifying heart plaque volume and characterizing plaque.
November 14, 2024
Heart Plaque
Ultrasound-guided nerve blocks safe for emergency pain management
By Amerigo Allegretto
Ultrasound-guided nerve blocks (UGNBs) performed by emergency clinicians could be safe for pain management.
November 13, 2024
Emergency 400
Thermal ablation effective long term in patients with thyroid cancer
By Will Morton
Outcomes over 10 years suggest that image-guided thermal ablation is a safe and effective option for patients with papillary thyroid carcinoma.
November 7, 2024
Thyroid Cancer
Could cranial ultrasound sub for brain MRI in imaging infants?
By Amerigo Allegretto
Cranial ultrasound could have utility for imaging infants with hypoxic-ischemic encephalopathy.
November 6, 2024
Baby Bottle
Ultrasound nonmass breast lesion features may signal malignancy
By Amerigo Allegretto
Some nonmass breast lesion characteristics on ultrasound exams can be considered suspicious for malignancy at screening ultrasound.
November 5, 2024
Images depict a 43-year-old woman with a malignant nonmass lesion that was diagnosed as microinvasive ductal carcinoma. (A) Transverse and (B) longitudinal ultrasound images show a hypoechoic nonmass lesion (solid arrows) with segmental distribution in the left breast. The lesion has associated calcifications (dashed arrows in A). (C) Longitudinal color Doppler ultrasound image shows high vascularity. (D) Magnified image in the mediolateral oblique view from screening mammography shows grouped calcifications (arrows), which are considered a mammographic correlate of the ultrasound-detected nonmass lesion (A radiopaque marker attached to the skin is visible in the image because the mammographic exam was performed after screening breast ultrasound). Ultrasound-guided core needle biopsy and pathologic examination revealed ductal carcinoma in situ, but the lesion was upgraded to microinvasive ductal carcinoma at subsequent surgery (2.5-cm ductal carcinoma in situ, histologic grade II, estrogen receptor-positive, progesterone receptor-positive, human epidermal growth factor receptor type 2-negative).
Page 1 of 512
Next Page