Scanner receives FDA clearance

Oct. 4, 2007
AFP Imaging Corporation given approval to market company's advanced NewTom VG Cone Beam Computed Tomography Scanner.

ELMSFORD, New York--AFP Imaging Corporation has announced that it has received 510K clearance from the U.S. Food and Drug Administration to market the company's advanced NewTom VG Cone Beam Computed Tomography Scanner.

This proprietary, dental imaging system provides the clinician with detailed three-dimensional, radiographic images of the teeth and jaws along with optimal patient comfort through flexible seating options. NewTom VG patients can now stand, sit, or remain in their wheel chairs while being scanned.

The unit's smaller footprint makes it ideal for in office examination procedures when space is limited in the operatory. The primary applications are for diagnosis and treatment planning for dental implants, orthodonture and oral surgery plus Ear Nose and Throat procedures.

The NewTom Cone Beam Computed Tomography Scanners are dedicated X-ray imaging devices that acquire the clinical image from a 360-degree, rotational X-ray sequence. The digitally reconstructed 3-D radiograph provides superior details of the dento-maxillo-facial complex as well as for the field of maxillofacial surgery.

The software reconstructs an image from the examined anatomical volume, producing a display of three-dimensional images, from any point of view. It is estimated that the market for dental CBCT systems, worldwide, will be more than $600 million over the next few years.

NewTom VG makes use of the same technology and proprietary software as AFP Imaging's NewTom 3G that provides a horizontal support table to accommodate the needs of the elderly, infirm or trauma patients, as well as small children.

AFP Imaging is the only Cone Beam Computed Tomography scanning supplier to currently provide both vertical and horizontal configurations. The products are manufactured by Quantitative Radiology, srl (QR) Verona, Italy, a wholly owned subsidiary of AFP Imaging.

For more than 10 years, QR has been a global CBCT leader and is the company's research, development and manufacturing source for the proprietary NewTom technology.

David Vozick, Chairman of AFP Imaging, said, "The dental profession increasingly recognizes the value of three-dimensional imaging over historic two-dimensional analog X-ray films or digital radiographs. The NewTom VG, as well as the NewTom 3G, provides more accurate images to facilitate patient evaluations, treatment planning and clinical efficiency. We believe that three-dimensional radiography is becoming the standard of care in dentistry and other professions for diagnosis and treatment of these complex cases."