AMS files 510(k) for Aurora scanner

Article

Advanced Mammography Systems has filed a 510(k) application with the Food and Drug Administrationfor Aurora, the company's dedicated MR mammography system. TheWilmington, MA, company, which is a majority-owned subsidiaryof fast MRI developer Advanced NMR

Advanced Mammography Systems has filed a 510(k) application with the Food and Drug Administrationfor Aurora, the company's dedicated MR mammography system. TheWilmington, MA, company, which is a majority-owned subsidiaryof fast MRI developer Advanced NMR Systems, unveiled Aurora atlast year's Radiological Society of North America meeting (SCAN11/23/94). The firm filed Aurora's 510(k) application in lateFebruary.

Aurora features a 0.5-tesla superconducting magnet that ishidden behind the rear wall of the examination room. The patientlies prone on the table and enters the magnet bore feet first.The patient's breasts are cupped without compression in built-inradio-frequency coils that are accessible from below for biopsy.List price of the system is expected to be $495,000.

Advanced Mammography Systems is in the final stages of negotiationswith several medical facilities for beta-site installations ofthe scanner, the company reported.

The company also reported that it has completed the redemptionof outstanding redeemable warrants for the purchase of the company'sstock. Advanced Mammography Systems said 773,935 warrant holdersout of a total 774,595 elected to purchase its stock at a priceof $3 a share. The transaction generated $2.3 million, which willbe used for R&D and working capital purposes.

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.