Norland receives PMA for ultrasound bone unit
Bone densitometry vendor Norland Medical Systems and its partner, U.K.-based McCue, have received premarket approval clearance from the Food and Drug Administration for CubaClinical, an ultrasound bone measurement system. CubaClinical is a dry system and
Bone densitometry vendor Norland Medical Systems and its partner, U.K.-based McCue, have received premarket approval clearance from the Food and Drug Administration for CubaClinical, an ultrasound bone measurement system. CubaClinical is a dry system and carries a large clinical database, according to Norland executives.
After terminating a two-year alliance with Canadian firm IMRO, White Plains, NY-based Norland signed an exclusive distribution and service agreement in June 1999 with McCue, which developed CubaClinical (SCAN 8/4/99). Norland distributes McCue systems in the U.S., Canada, Europe, Africa, the Middle East, and the Pacific Rim. CubaClinical lists at approximately $20,000.