The pedCAT, a weight-bearing, 3D CT imaging device for the foot and ankle region—small enough to fit in a doctor’s office—is projected to be available soon for sale in Canada, Europe and South America.
CurveBeam Earns Certification for pedCAT
1 min read Premium comments
Secondary
Made by CurveBeam, of Warrington, Pennsylvania, the pedCAT has a 4’ by 5’ footprint and, according to its manufacturer, can provide a scan of a single foot or both feet in less than a minute at minimal levels of radiation. The pedCAT has been available for sale in the United States and some international markets since April 2012.
CurveBeam received a certificate of registration with Intertek Testing Services, a certification body of the International Organization for Standardization, on July 7, 2012. The certificate signifies the company’s design, development, manufacturing, installation, training and service management systems are compliant with international standards.
CurveBeam is now qualified to apply for approval for the pedCAT from Health Canada, which reviews medical devices to assess their safety, effectiveness and quality before authorizing them for sale in Canada. CurveBeam is now qualified to apply for CE marking. The company expects to receive approvals to market the pedCAT in Japan within a year and is in the process of setting up its international dealer network, said Dave Cowan, vice president of operations.
“This certification underscores CurveBeam’s commitment to not only design & produce world class products, but also provide exemplary service and support in all markets it serves, ” said CurveBeam CEO Arun Singh in the July 10 press release. “We are excited to be able to offer this ground-breaking technology to various international markets in the upcoming future.”
CurveBeam was formed in 2009 with the goal of providing Cone Beam CT capabilities to the orthopedic and podiatry specialties at a fraction of the price of traditional CT equipment.
React:
Discussion
This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
Join the conversation
Orthopedic professionals are discussing this. Sign in and upgrade to read every comment and add your voice.