Artoscan extremity MRI gets FDA nod
Lunar's move into dedicated MRI imaging is proceeding smoothly.The ink was barely dry on Lunar's agreement for exclusive NorthAmerican distribution rights to Esaote Biomedica's Artoscan dedicatedMRI extremity scanner when the unit received 510(k)
Lunar's move into dedicated MRI imaging is proceeding smoothly.The ink was barely dry on Lunar's agreement for exclusive NorthAmerican distribution rights to Esaote Biomedica's Artoscan dedicatedMRI extremity scanner when the unit received 510(k) marketingclearance from the Food and Drug Administration.
The FDA's action gives Lunar the go-ahead to show Artoscanas a commercial product at the Radiological Society of North Americaconference next month.
Esaote of Italy unveiled Artoscan at last year's RSNA meetingand the system will be shown in Lunar's booth this year (SCAN10/6/93 and 10/7/92). Lunar, of Madison, WI, will market the 0.2-teslapermanent magnet to hospitals looking for a low-cost unit to provideextremity scanning while leaving more expensive MRI systems openfor full-body imaging.
Artoscan gets the jump on niche competitor Magna-Lab, whichis also developing an extremity scanner but has not yet filedfor FDA approval. Magna-Lab plans to bring one of its scannersto this year's RSNA meeting and will show images from the unit,according to a company spokesperson.
An initial prototype of Magna-Lab's three-sided head and extremityimager, the Magna-SL, was shown at the 1992 RSNA exhibition (SCAN12/2/92).