Medical imaging device developer CurveBeam said yesterday it won CE Mark approval in the European Union for its LineUP and InReach orthopedic extremity computed tomography scanning systems.
The Warrington, Penn.-based company said its LineUP system is designed to allow the patient to stand during scanning to assess weight-bearing or load-bearing positions, and can perform bilateral scans of legs from below the heel to above the knee.
The company’s InReach system has been cleared by the FDA since last year, and the company said it has been installed in multiple hand surgery centers in the US since its clearance.
“The recent CE Mark certification of the LineUP and InReach systems demonstrates CurveBeam’s ambition and commitment to elevating the standard of care in imaging for orthopedics. Worldwide anticipation for the LineUP system has been clamorous, and CurveBeam is confident the LineUP will make an even larger impact than the pedCAT did in understanding of lower extremity conditions,” prez & CEO Arun Singh said in a prepared statement.
“We look forward to working with our partners across Europe to promote the LineUP and InReach systems. CurveBeam has demonstrated strong commitment to the European markets and we are confident its presence will continue to grow rapidly,” European operations director Guy Long said in a press release.
Last May, Curvebeam said it won FDA 510(k) clearance for the InReach cone beam CT imaging system.