NewTom BIOLASE VG3 Panoramic Oral X-Ray System Receives FDA Clearance
VG3 Expected to Be Available for Delivery in June 2013
Irvine, Calif. -- BIOLASE, Inc., the world's leading manufacturer and distributor of dental lasers, announced today that the U.S. Food and Drug Administration (the "FDA") has cleared the NewTom™ BIOLASE VG3 ("VG3") digital panoramic, cephalometric, and tomographic extra-oral X-ray system which BIOLASE® will market and distribute in the U.S. for $50,000 to $120,000. BIOLASE is the exclusive distributor of NewTom digital imaging products for the dental market in the U.S. and Canada.
The VG3 is a significant complement to the ultra-high performance full field of view ("FOV") provided by the NewTom VGi, which is currently distributed by BIOLASE. The new VG3 is a truly modular hybrid 2D/3D system that can start as a digital 2D panoramic X-ray system, which replaces traditional film-based panoramic units, that can be upgraded at any time to add either a cephalometric sensor and software, necessary for orthodontics and diagnosing head, jaw, and facial pain, and/or 3D cone-beam-computed-tomography ("CBCT") with an 11" x 8" FOV, used for implants, endodontics, gum disease, sinus problems, and oral and maxillofacial surgery.
Federico Pignatelli, Chairman and Chief Executive Officer, commented, "We are very pleased that the NewTom BIOLASE VG3 has received FDA clearance in the U.S. The VG3 fills a significant need for doctors who want to replace their older, film-based panoramic units with a competitively priced, modern digital 2D unit that offers flexibility to add 3D capabilities as they expand the range of endodontic and periodontic procedures they perform. Digital panoramic systems emit a fraction of the radiation compared to older film-based systems, which make them much safer for patients and staff. Digital imaging also plays a very important role in the development of improved treatment plans, the proper placement of implants, and the early diagnosis of diseases."
The VG3 comes equipped with NewTom's NNT 4.0 imaging analysis software and incorporates NewTom's patented Safebeam™ technology which emits the lowest possible dosage of radiation. Safebeam technology automatically adjusts the radiation dosage and continuously monitors systems operations thereby eliminating the possibility of unnecessary exposures making it the safest available for patients and staff.
"The VG3 comes equipped with a removable 2D panoramic sensor that allows operators to safely remove it for use on the cephalometric arm," said Bill Brown, Vice President of Sales & Marketing. "Billed as an ideal solution for practices that require a high-quality device at a competitive price, the 2D panoramic sensor allows practitioners to make dynamic orthogonal tomogram examinations with the ability to upgrade the base panoramic VG3 with a cephalometric sensor or software and a digital 3D CBCT at any time."