Healthcare Industry News: cardiac monitor
News Release - August 30, 2012
Zynex Receives FDA 510(k) Clearance for InWave Medical DeviceLONE TREE, CO--(Healthcare Sales & Marketing Network)- Zynex, Inc. (ZYXI), a provider and developer of non-invasive medical devices for electrotherapy, stroke rehabilitation, neurological diagnosis and cardiac monitoring, announced that it received FDA 510(k) clearance on its InWave medical device.
The InWave device is the newest product in the Zynex portfolio, and will be manufactured, marketed and sold through our Zynex Medical subsidiary. This device is used primarily for treating female urinary incontinence. Incontinence is defined as the involuntary loss of bladder or bowel control. According to the National Association for Continence, urinary incontinence affects 200 million people world-wide, and it is believed that 80% of those sufferers are women.
Zynex's CEO, Thomas Sandgaard, commented; "We are very excited about the introduction of this new product. The InWave adds to our already broad product line and is reimbursed by health insurance. We believe it will provide our expanding sales force an additional tool to fuel revenue generation in our rapid growing Zynex Medical subsidiary."
Zynex (founded in 1996), operates under three primary business segments; Zynex Medical, Zynex NeuroDiagnostics and Zynex Monitoring Solutions. Zynex Medical engineers, manufactures, markets and sells its own design of electrotherapy medical devices for electrotherapy, used for pain management and rehabilitation. Zynex Medical's product lines are fully developed, FDA-cleared and commercially sold world-wide. Zynex NeuroDiagnostics, sells the company's proprietary NeuroMove device designed to help stroke and spinal cord injury patients and is currently expanding into markets for EMG, EEG, sleep pattern, auditory and nerve conductivity neurological diagnosis devices through product development and acquisitions. Zynex Monitoring Solutions, currently in the development stage, has been established to develop and market medical devices for non-invasive cardiac monitoring.
Safe Harbor Statement
Certain statements in this release are "forward-looking" and as such are subject to numerous risks and uncertainties. Actual results may vary significantly from the results expressed or implied in such statements. Factors that could cause actual results to materially differ from forward-looking statements include, but are not limited to, the need to obtain additional capital in order to grow our business, our ability to engage additional sales representatives, the success of such additional sales representatives, the need to obtain FDA clearance and CE marking of new products, the acceptance of new products as well as existing products by doctors and hospitals, larger competitors with greater financial resources, the need to keep pace with technological changes, our dependence on the reimbursement from insurance companies for products sold or rented to our customers, acceptance of our products by health insurance providers, our dependence on third party manufacturers to produce our goods on time and to our specifications, implementation of our sales strategy including a strong direct sales force, the uncertain outcome of pending material litigation and other risks described in our filings with the Securities and Exchange Commission including the "Risk Factors" section of our Annual Report on Form 10-K for the year ended December 31, 2011.
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