CT imaging company CurveBeam revealed on Monday the receipt of the US FDA's 510(k) clearance for its LineUP Multi-extremity weight bearing CT system for launch in the orthopedic extremity imaging market.
The company said the compact system enables radiologists and orthopedic specialists to visualize three-dimensional bone detail of the lower extremities, while the patient is standing, so anatomy can be assessed while in the "weight bearing" or "load bearing" position.
In conjunction, the LineUP can perform bilateral scans of entire legs, the hand, wrist as well as elbow The LineUP system can be plugged into a standard wall outlet and has minimal shielding requirements. Radiation dose to the patient is significantly less than a conventional CT scan.
According to the company, the weight bearing CT imaging for body extremities became commercially available in 2012. The device has been added to the imaging services of numerous hospital foot & ankle sections, orthopedic clinics and podiatry offices worldwide. Its InReach system for hand, wrist and elbow received FDA clearance in 2017. Specialists extol the ability to confirm a scaphoid fracture diagnosis or distal radius fracture diagnosis at the point-of-care.
Foresee Pharmaceuticals receives positive CHMP opinion for CAMCEVI 21 mg
Great Novel Therapeutics' GNTbm-38 approved by US FDA for Phase I trial
Johnson & Johnson reports US FDA approval of TECVAYLI plus DARZALEX FASPRO for RRMM
Airiver Medical's Airiver Pulmonary DCB receives US FDA Breakthrough Device Designation
Sanaregen receives FDA clearance for retinal degeneration clinical trial
Esperion to acquire Corstasis, expanding cardiovascular portfolio
ReviR Therapeutics doses first participant in First-in-Human Phase 1 clinical trial of RTX-117
BD receives FDA clearance for Surgiphor 1000mL irrigation system
United Therapeutics' ralinepag reduces risk of clinical worsening in pivotal PAH study
FDA accepts rusfertide NDA and grants priority review for polycythemia vera