Medical imaging device developer CurveBeam said today it won FDA 510(k) clearance for the InReach cone beam CT imaging system.
The Warrington, Penn.-based company’s InReach is an ultra-compact CT scanner designed to provide high-contrast 3D datasets of bony anatomy. The system is designed primarily for the hand, wrist, elbow and lower extremities in non-weight bearing positions.
The InReach is the 2nd extremity CT imager that the company has released so far.
“The InReach will revolutionize the speed and accuracy of assessment of upper extremity conditions that specialists have traditionally found challenging to diagnose with plain X-Ray, such as scaphoid fractures. The InReach continues the company’s mission to elevate advanced diagnostic imaging capabilities to enhance orthopedic care,” CurveBeam prez & CEO Arun Singh said in a press release.
CurveBeam said that the InReach was designed for point-of-care with a small footprint, self-shielded design and standard power requirements for fast diagnosis and accurate treatment planning.
The company said it is currently developing a next-gen multi-extremity device, called the LineUP, which is designed to provide bilateral weight-bearing images of knees as well as images of hands, wrists and elbows. The company is hopeful for an FDA submission by July.
