FDA approves OSI's ultrasound osteoporosis risk device:
This article was originally published in Clinica
The US FDA has granted PMA approval to Osteometer MediTech to market its UltraSure DTU-one ultrasound scanner for the assessment of osteoporotic fracture risk. The company says its product is the first imaging ultrasound system to receive PMA clearance for this indication; it is already available commercially outside the US. Osteometer MediTech is a subsidiary of Hawthorne, California-based OSI Systems.