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. He believes that it can also help in pre-surgical planning for implant placement. In addition to feet, CurveBeam is also looking at expanding its use to people with foot problems associated with complications from diabetes and for arthritic conditions.
Now that the European markets are open to the Warrington, Pennsylvania-based company’s device, it will be interesting to see what the uptake is like. In the US market, re-imbursement issues can frequently pose a challenge to companies with new technology, even after they’ve met the regulators’ requirements.
At the start of 2012, Medicare began requiring that a device be accredited before it will reimburse scans. As part of the accreditation guidelines, physicians are required to interpret the scans and a radiology technician is required to act as the operator of the device. Singh told MedCity News last year that it was working with accreditation bodies and national medical organizations to create an accreditation pathway tailored for cone beam CT devices.