FDA clears SMV’s coincidence detection

April 16, 1997

Nuclear medicine vendor SMV America has received 510(k) clearance from the Food and Drug Administration for its Volumetric Coincidence Reconstruction (VCR) technique for its Vision FX-80 gamma camera. SMV, of Twinsburg, OH, joins ADAC Laboratories and

Nuclear medicine vendor SMV America has received 510(k) clearance from the Food and Drug Administration for its Volumetric Coincidence Reconstruction (VCR) technique for its Vision FX-80 gamma camera. SMV, of Twinsburg, OH, joins ADAC Laboratories and Picker International in the group of vendors that have 510(k) clearance for a coincidence-detection technique.

In other SMV America news, the company reported record growth in both orders and product sales for the fourth quarter of 1996, although as a private company it did not release specific dollar figures. The company said that camera and computer orders were up 189%, and shipment revenues increased 64% compared with the same period the year before. For the year, SMV said that product revenues grew by 30% and orders doubled.

SMV America ended the year with a 15.5% market share and a large backlog, the company said, while SMV International, its sister company, saw its market share in Europe expand to 25%.