×

Error message

  • Failed to authorize with Brightcove
  • Failed to authorize with Brightcove
  • Failed to authorize with Brightcove
  • Failed to authorize with Brightcove
  • Failed to authorize with Brightcove
News | October 12, 2006

FDA Clears VIAS Used with Tissues Stained for p53

TriPath Imaging Inc. and Ventana Medical Systems Inc. have announced that TriPath Imaging has received 510(k) clearance from the FDA for the Ventana Image Analysis System (VIAS) when used with tissues stained for p53. p53 is a tumor suppressor biomarker which is employed by pathologists as an adjunct to histopathology and is used to assist with diagnosis and the prognostic assessment of cancer.
Research studies have shown that high levels of the p53 protein have been associated with more aggressive breast cancers. Precise quantitative measurement of p53 expression in breast biopsy samples may be used to aid in the overall management and treatment of breast cancer patients.
"FDA clearance for the analysis of p53 increases the clinical utility of VIAS as an aid to the anatomical pathologist. This is the first time the p53 marker has been cleared by the FDA for use with an image analysis system," said Paul R. Sohmer, M.D., chairman, president and CEO of TriPath Imaging. "We expect to continue to further expand the application menu supported by VIAS with additional 510(k) applications."

Related Content

Technology | Focused Ultrasound Therapy | June 19, 2018
EDAP TMS SA has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Focal One device for...
Epsilon Imaging Demonstrates Strain Imaging Integration for Echo Programs at ASE 2018
News | Cardiovascular Ultrasound | June 19, 2018
Clinical practice, along with guidelines and research, have shown that speckle tracking strain imaging can improve...
FDA Clears Bay Labs' EchoMD AutoEF Software for AI Echo Analysis
Technology | Cardiovascular Ultrasound | June 19, 2018
Cardiovascular imaging artificial intelligence (AI) company Bay Labs announced its EchoMD AutoEF software received 510(...
Hitachi Medical Systems Europe Named Imaging Supplier for London Prostate Cancer Program
News | Prostate Cancer | June 14, 2018
Hitachi Medical Systems Europe has been awarded the contract to supply six ultrasound systems as part of the RAPID...
How AI and Deep Learning Will Enable Cancer Diagnosis Via Ultrasound

The red outline shows the manually segmented boundary of a carcinoma, while the deep learning-predicted boundaries are shown in blue, green and cyan. Copyright 2018 Kumar et al. under Creative Commons Attribution License.

News | Ultrasound Imaging | June 12, 2018 | Tony Kontzer
June 12, 2018 — Viksit Kumar didn’t know his mother had...
Olympus and Hitachi Healthcare Americas Introduce Arietta 850
News | Ultrasound Imaging | June 04, 2018
Olympus, a global technology leader in designing and delivering innovative solutions for medical and surgical procedu
New Ultrasound Guidelines Reliably Identify Children Who Should be Biopsied for Thyroid Cancer

Image courtesy of Loyola Medicine

News | Pediatric Imaging | May 29, 2018
A Loyola Medicine study has found that new ultrasound guidelines can reliably identify pediatric patients who should be...
Samsung Receives FDA Clearance for Premium Ultrasound System RS85
Technology | Ultrasound Imaging | May 07, 2018
NeuroLogica, a subsidiary of Samsung Electronics Co. Ltd., announced the Samsung RS85 ultrasound system has received U....
3D-4D ultrasound of a fetus imaged with a GE Volusion E10 system. It shows the yoke sac. This is a baby ultrasound, also referred to as fetal ultrasound or prenatal ultrasound.

3D-4D ultrasound of a fetus imaged with a GE Volusion E10 system. It shows the yoke sac.

Feature | Ultrasound Women's Health | May 07, 2018
Below is a collection of prenatal ultrasound images from the ITN archive.
Esaote Change of Ownership Completed
News | Ultrasound Imaging | April 30, 2018
The acquisition of biomedical equipment company Esaote SpA’s share capital was completed on April 19, the company...
Overlay Init