Korean FDA clearance for Planmed Verity® Extremity Scanner
On January 16, 2013, Planmed Verity® Extremity Scanner received clearance from the Korean Food and Drug Administration (KFDA) for medical imaging. In Korea, Planmed Verity is represented by the local distributor Dong Kang Medical Systems Co., Ltd.
Planmed Verity® is designed to find subtle extremity fractures during the first visit to the clinic – the types of fractures that have most commonly been missed when only using 2D radiographs. Planmed Verity Extremity Scanner is a unique solution to the problem; it provides fast 3D imaging at the point of care. It is intended for pre- and postoperative imaging, and 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, Planmed Verity also allows for weight-bearing imaging of the extremities.
As a dedicated extremity scanner, Planmed Verity adapts to the patient with anatomy-specific imaging programs, movements, and trays. Easily adjustable, soft surfaced gantry and motorized positioning trays help in finding a comfortable position for various examination procedures. The adjustable user interfaces and efficient all-in-one workflow are also designed to maximize the operator’s soothing presence for the patient.
“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,” says Vesa Mattila, Vice President of Planmed Oy. "South Korea is one of the most innovative and medically advanced countries in Asia. Our distribution partner, Dong Kang Medical Systems Co., Ltd., has an excellent reputation at the best medical institutions in South Korea."
“We are very pleased to present this unique, mobile orthopedic imaging device to our Korean customers,” says Jae Won Shim, President of Dong Kang Medical Systems Co., Ltd. "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."
Planmed’s products are well known for their exquisite design and user ergonomics. 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.
For further information, please contact:
Mr Vesa Mattila, Vice President, Planmed Oy
Tel. 358 20 7795 301
Planmed Oy and the Planmeca Group
Planmed Oy develops, manufactures, and markets advanced imaging equipment and accessories for mammography and orthopedic imaging. Planmed's extensive mammography product range covers digital and analog units, stereotactic biopsy devices, and breast positioning systems for an early detection of breast cancer. Within orthopedic 3D imaging Planmed offers low dose extremity CT imaging for quicker, easier and more accurate diagnosis at the point-of-care.
Planmed Oy exports more than 98% of its production to over 70 countries worldwide. The principal markets are Europe, Asia as well as North andLatin Americawhere the company has considerable market shares. Planmed Oy is part of the Finland-based Planmeca Group which manufactures and markets advanced equipment for medical and dental fields. The Group employs approximately 2,500 professionals and the estimated turnover for the year 2013 is MEUR 760.