Healthcare Industry News: X-ray imaging
News Release - October 4, 2007
AFP Imaging Corporation Receives FDA Clearance to Market NewTom(TM) VG Cone Beam Computed Tomography ScannerELMSFORD, N.Y.--(HSMN NewsFeed)--AFP Imaging Corporation (OTCBB: AFPC.OB ) announced today that it has received 510K clearance from the U.S. Food and Drug Administration (FDA) to market the Company's advanced NewTom(TM) 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 ("Vertical Generation"), 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 can reconstruct any 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, world-wide, 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(TM) 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 (CBCT) 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 over ten 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."
About AFP Imaging
AFP Imaging is a diagnostic imaging supplier whose products are distributed worldwide with clinical applications for dental, medical and veterinary professionals. The company's quality assurance program is ISO 9001 certified, an international standard. The company's digital imaging technologies and product lines are providing the gateway for future internal and external growth. Through its global distribution network, the company has produced branded products that are installed in approximately 100,000 dental and medical facilities. Each site serves as a reference point for future user upgrades of equipment. The company's products are distributed under various trademarked brand names that include AFP, DENT-X, EVA and NEWTOM. For additional corporate information please visit our web sites at www.afpimaging.com, www.dent-x.com and www.newtomdental.com.
The remarks contained in this press release and presented elsewhere by management from time to time contain forward-looking statements, which involve risks and uncertainties, including statements regarding the Company's plans, objectives, expectations and intentions. The Company's actual results may differ significantly from the results discussed in this press release or in other forward-looking statements presented by management due to the inability to maintain adequate working capital, failure of revenue on new products to develop as estimated, regulatory delays, loss of existing customers, the Company's inability to meet increasing demand for its new products, general downward trends in the Company's industry and other risk factors as described in the Company's filings with the Securities and Exchange Commission. The Company expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any such statements to reflect any change in the Company's expectation or any change in events, conditions or circumstances on which such statement is based.
Source: AFP Imaging
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