Fischer system heads toward FDA filing

Article

Fischer Imaging of Denver is collecting the clinical data to supporta 510(k) application for its SenoScan full-view digital mammographyscanner. Fischer has placed beta SenoScan units at Brooke ArmyMedical Center in Fort Sam Houston, TX, Thomas Jefferson

Fischer Imaging of Denver is collecting the clinical data to supporta 510(k) application for its SenoScan full-view digital mammographyscanner. Fischer has placed beta SenoScan units at Brooke ArmyMedical Center in Fort Sam Houston, TX, Thomas Jefferson Universityin Philadelphia, and the University of California at San Francisco.

Fischer and other companies developing full-field systems willbe able to go the 510(k) route rather than the more rigorous premarketapproval path to obtain regulatory clearance. The FDA decidedearlier this year to allow Fischer and other companies developingfull-field digital mammography systems to submit 510(k) applicationsrather than PMA filings.

In addition to SenoScan, Fischer's RSNA booth display willinclude Performa, an ultrasound scanner for breast biopsy guidancethat Fischer has licensed from Acoustic Imaging; the MammotestPlus stereotactic breast biopsy system; and CVX, a new angiographicinterventional positioner.

Recent Videos
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
What New Research Reveals About the Impact of AI and DBT Screening: An Interview with Manisha Bahl, MD
Related Content
© 2025 MJH Life Sciences

All rights reserved.