TransScan wins additional FDA clearance

Article

Mammography firm TransScan Research and Development has received clearance from the Food and Drug Administration for a premarket approval supplement for its TS-2000 electrical impedance breast scanning system that covers improvements in the unit’s

Mammography firm TransScan Research and Development has received clearance from the Food and Drug Administration for a premarket approval supplement for its TS-2000 electrical impedance breast scanning system that covers improvements in the unit’s design and operation. The Ramsey, NJ, firm announced the news along with Siemens Medical Systems of Iselin, NJ, with which it signed a marketing agreement last December (SCAN 1/7/99).

A hand-held device that measures electrical impedance in breast tissue, TS-2000 includes a ground-electrode cylinder that patients hold as it transmits a low-voltage electrical signal through the body. A probe placed on the breast and moved across the skin measures changes in the signal. In real-time, the probe produces images on a computer screen that reveal differences in the electrical impedance between malignant tumor tissue and normal tissue.

The unit was initially cleared by the FDA in April for use as an adjunct to mammography for follow-up exams in patients with equivocal mammograms (SCAN 4/28/99). TransScan hopes that the cleared PMA supplement will pave the way for the unit to be used for other types of cancer.

Newsletter

Stay at the forefront of radiology with the Diagnostic Imaging newsletter, delivering the latest news, clinical insights, and imaging advancements for today’s radiologists.

Recent Videos
SNMMI: Emerging PET Insights on Neuroinflammation with Progressive Apraxia of Speech (PAOS) and Parkinson-Plus Syndrome
Improving Access to Nuclear Imaging: An Interview with SNMMI President Jean-Luc C. Urbain, MD, PhD
SNMMI: 18F-Piflufolastat PSMA PET/CT Offers High PPV for Local PCa Recurrence Regardless of PSA Level
SNMMI: NIH Researcher Discusses Potential of 18F-Fluciclovine for Multiple Myeloma Detection
SNMMI: What Tau PET Findings May Reveal About Modifiable Factors for Alzheimer’s Disease
Emerging Insights on the Use of FES PET for Women with Lobular Breast Cancer
Can Generative AI Reinvent Radiology Reporting?: An Interview with Samir Abboud, MD
Mammography Study Reveals Over Sixfold Higher Risk of Advanced Cancer Presentation with Symptom-Detected Cancers
Combining Advances in Computed Tomography Angiography with AI to Enhance Preventive Care
Study: MRI-Based AI Enhances Detection of Seminal Vesicle Invasion in Prostate Cancer
Related Content
© 2025 MJH Life Sciences

All rights reserved.