22 February 2013 | Regulatory | By BioSpectrum Bureau
Planmed's Verity Extremity CT scanner gets Korean FDA approval
Singapore: Planmed, which is represented in Korea by Dong Kang Medical Systems, received clearance for its Verity Extremity Scanner from the Korean Food and Drug Administration (KFDA). It is designed to find subtle extremity fractures during the first visit to the clinic.
These are the types of fractures that have most commonly been missed when only using 2D radiographs. It provides fast 3D imaging at the point-of-care and is intended for pre and postoperative imaging. It has better resolution and patient adaptability and uses a significantly lower dose of radiation than full-body CTs. Unlike any other 3D imaging device, Verity also allows for weight-bearing imaging of the extremities.
Planmed Verity utilizes similar technology that is already in use in the Planmeca CBCT systems, which are well-known and preferred by many Korean universities and private customers. Planmed Verity has the CE mark and thus, is available for sale in the EU and many other countries where the CE certificate permits sales. Planmed Verity is also FDA cleared and available for sale in the US.
Ms Vesa Mattila, VP, Planmed Oy, said that, "Planmed Verity is the first and only CT system in the world that can image seated, supine and standing patients. We are excited that this innovative, low-dose orthopedic imaging system is now available also in Korea. We are confident that it will be well received."
Mr Jae Won Shim, president, Dong Kang Medical Systems, said that, "We are very pleased to present this unique, mobile orthopedic imaging device to our Korean customers. With Planmed Verity, our Korean customers can get a fast and accurate diagnosis at the point of care. It is ideal for low-dose imaging of extremities, such as a foot, ankle, knee, and hands."