A medical device manufacturer with a 3-D CAT scanning device that takes pictures of a patient’s feet from a standing position is seeking regulatory approval in Europe.
As part of its strategy, the Pennsylvania-based CurveBeam is opening a UK office to facilitate communication with European regulators as it applies for CE Mark approval for its pedCAT device. It will also serve as a platform for European sales if it gets approved.
By taking images of the patient’s feet in a standing position, it is intended to provide a more accurate picture reflecting the alignment of the subject’s bones and joints. It is designed to aid in diagnosing foot and ankle problems like fractures, infections, spurs and for presurgical purposes to ensure the accurate placement of implants to reduce the need for additional surgery and reduce healthcare costs. Although standing magnetic resonance imaging devices also provide 3-D images, they are better suited for soft tissue and ligaments.
The device received 510(k) clearance from the U.S. Food and Drug Administration in April.
The company is also setting its sights on other non-U.S. markets. It plans to set up a distribution network in Brazil, Canada, the Middle East and South Korea, and it wants to accomplish all of that by the end of the year. Last month, it received a certificate of registration with Intertek Testing Services International Organization for Standardization, signifying the device’s compliance with international standards. It expects to receive approvals to market the pedCAT in Japan sometime next year.
“We’re ambitious; we want to move fast,” said Arun Singh, the CEO of CurveBeam told MedCity News.
It expects to add six to 10 staff this year and grow to about 50 staff next year.
The company is keen to explore non-U.S. markets as it goes through the process of getting private insurance companies and Medicare to provide reimbursement to orthopedic surgeons and the podiatrists who will use the device. “We are putting together a case of why it will benefit patients and reduce the number of surgeries,” said Singh. “The savings will be enormous.”