FEDs OK Epley Omniax System to Help Dizzy Millions

Vesticon's Omniax device has been cleared by the FDA.

The Food and Drug Administration (FDA) has informed Vesticon Corp. that the company’s new Omniax device has been cleared to proceed to market in the United States. This is the first ever OK’d for national use of a device designed to assist in the diagnosis and treatment of balance disorders and vertigo, including benign paroxysmal positional vertigo (BPPV). An estimated 15 million Americans alone currently suffer from balance problems and vertigo, which often is debilitating to those it afflicts. A recent Portland “start up,” Vesticon Corp., developed the Omniax, and is in talks with several multi-national medical device companies about distribution. “We believe that the FDA action for the Omniax is significant to achievement of our mission of helping physicians and their patients achieve Victory Over Vertigo,” said President and CEO Cathryn Epley. The Omniax is the first in the vestibular field to receive clearance to assist doctors with treatment of this dizziness. It is also one of the few devices cleared to assist doctors in diagnosis. Existing technologies typically only provide a general assessment or evaluation and none are cleared for treatment applications. The Omniax includes a software-guided patient positioning system (see photo) using infrared goggles that assist physicians in analyzing abnormal patterns of eye movement. These are involuntary responses to loose particles floating in the semi-circular canals of the ear. At the same time, the Omniax also helps to “reposition” those particles out of canals by rotating patients to varying positions, including a “360 -degree flip.” The Omniax product has been highly anticipated by the medical community and Epley says it has a backlog of customers eager to access the Omniax. Epley said Vesticon hopes to begin shipping to its national customer base this Fall.