Magna-Lab files 510(k) for niche MRI
Niche MRI developer Magna-Labfiled for Food and Drug Administration 510(k) clearance last monthfor its Magna-SL extremity scanner. While the filing marks a milestonefor the Hicksville, NY, company, it will have to play catch-upwith competitor Lunar,
Niche MRI developer Magna-Labfiled for Food and Drug Administration 510(k) clearance last monthfor its Magna-SL extremity scanner. While the filing marks a milestonefor the Hicksville, NY, company, it will have to play catch-upwith competitor Lunar, which received 510(k) clearance last yearfor its Artoscan niche system (SCAN 11/3/93).
Magna-SL is a three-sided 0.3-tesla permanent magnet systemthat weighs about 5000 pounds. Magna-Lab intends to market thesystem as a scanner ideal for performing extremity scans at acost one-half to one-third of whole-body scanners. Magna-Lab mayalso promote the unit as capable of conducting brain scans.
While Magna-Lab waits for the FDA's go-ahead, it will moveforward with marketing efforts in Europe, where Magna-SL has regulatoryapproval. The company signed a $4 million sales and distributionagreement in January and will begin shipments in the second halfof this year. Initial sales could total $10 million if existingletters of intent and options are exercised. Magna-SL systemsare expected to sell for about $500,000.
Magna-Lab went public last year with an oversubscribed initialpublic offering that netted the firm $4.8 million (SCAN 5/5/93).
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