Korean FDA clearance for Planmed Verity® Extremity Scanner

Press release

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 local distributor Dong Kang Medical Systems Co., Ltd.

Planmed Verity® is designed to find subtle extremity fractures at the first visit to the clinic – fractures that have been the most commonly missed using only 2D radiographs. Planmed Verity Extremity Scanner is a unique solution to the problem with fast 3D imaging at the point of care. It is intended for pre- and postoperative imaging with better resolution, patient adaptability, and significantly lower dose than full-body CTs. Unlike any other 3D imaging device, Planmed Verity also allows 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 fast and accurate diagnosis at the point-of-care. It is ideal for low-dose imaging of extremities such as 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 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, Japan, and Oceania as well as North and Latin America where 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 750.