AMS files 510(k) for Aurora scanner
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.