Planmed Oy has obtained 510(k) clearance from the US Food and Drug Administration (FDA) for its Planmed Verity Extremity Scanner for providing fast 3D imaging of subtle extremity fractures that have been missed when using 2D radiographs at the point of care.
Using a significantly lower dose of radiation, the CE-marked orthopedic imaging system adapts to the patient with anatomy-specific imaging programs, movements, and carbon-fiber positioning trays.
The system, which is intended for pre- and postoperative imaging, also includes adjustable user interfaces and efficient all-in-one workflow for maximizing the operator’s soothing presence for the patient.
Planmed said the system’s easily adjustable, soft surfaced gantry and motorized positioning also help in finding a comfortable position for various examination procedures.
Planmed Oy vice president Vesa Mattila said, "Planmed Verity is the first and only CT system in the world that can image seated, supine and standing patients."
In response to the FDA’s clearance of Planmed Verity, the company’s US subsidiary Planmed USA will now sell, market and provide tech support for the product in North America.
Planmed Oy said it will showcase the imaging system at the American Association of Orthopedic Surgeons (AAOS) meeting, which will be held at Chicago, US starting from 19 March 2013.