CurveBeam's 3D Weight Bearing Imaging Scanner for Feet Gets European Regulatory Nod
2/12/2013 8:37:44 AM
I’m so used to hearing how U.S. medical device companies are first focusing on getting regulatory approval in Europe to commercialize their technology there before seeking clearance from the U.S. Food and Drug administration that it’s almost surprising when the opposite happens. But nearly a year after getting 510(K) clearance from the FDA, a Pennsylvania-based medical device startup has received the green light from European regulators to market its 3-D orthopedic imaging device. CurveBeam’s device, pedCAT, got a CE Mark last month, according to an e-mailed statement from CEO Arun Singh. It uses cone beam computer tomography to generate three-dimensional images of the foot and ankle. It is based on a 3-D dental imaging system, Singh developed at Imaging Sciences International in Hatfield, Pennsylvania, which was acquired by Danaher Corp. in 2007. Singh has claimed that the benefit of taking pictures of patients’ feet while in the standing position is that bones and ankles are in the proper alignment. It can take seconds rather than the minutes using a standing MRI would take, according to Singh.
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