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Aribex, Inc., a worldwide leader in handheld x-ray technologies, clarified that its Aribex NOMAD handheld x-ray devices are legal and not the subject of an investigation announced by the U.S. Food and Drug Administration (FDA).
The FDA investigation involves the illegal online sales of handheld dental and veterinary x-ray units by manufacturers outside the United States. Aribex stressed that the NOMAD, which is manufactured in the United States, is proven safe, FDA-cleared, and approved for use in almost all states. Aribex officials said the company continues to have a positive working relationship with the FDA along with other state and local radiation safety officials.
“Clinician and patient safety has always been our number-one priority in developing and distributing our handheld x-ray device,” said Ken Kaufman, Aribex president and CFO, “and we are disappointed to learn that other manufacturers may not share a similar perspective. Just as the FDA fulfills its responsibilities, Aribex is equally committed to its role as the pioneer of safe and effective, battery-powered, handheld x-ray systems.
“We support the FDA in their efforts to warn and protect, and we follow their message with one of our own: we ask dentists, hygienists, veterinarians and other certified radiation operators to understand that rapidly changing technology has made it possible for handheld x-ray systems to be both safe and effective. Not only is the NOMAD safe, patients and users have found that it improves their imaging experience,” said Kaufman.
Aribex affirmed that each of its x-ray products meets FDA requirements, including FDA 510(K) clearance and labeling. Company officials said that numerous studies and evaluations have found the NOMAD to be safe, including the Washington State Department of Health study referenced by the FDA. Aribex maintains that its NOMAD systems are superior in shielding and cone design characteristics when compared to other intraoral dental x-ray systems.
In response to challenges this may cause for U.S. dental and veterinary practices, Aribex is offering a $200 trade-up rebate on the purchase of a NOMAD to replace an illegal device. For more information on this rebate, affected practitioners should contact Aribex at 866-340-5522 or visit www.aribex.com.