HEALTH CARE : Davstar Waiting for FDA Approval to Market Its Incontinence Device
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Davstar Industries Inc. in Newport Beach is banking on a favorable review from the U.S. Food and Drug Administration to help boost its bottom line.
The medical device manufacturer said it has applied for approval to market its DriStar, an incontinence machine designed for elderly, bedridden and wheelchair-bound women.
The FDA must now review the device and decide whether it can be marketed in the United States. Davstar Chief Executive Jerry Silver said that, if approved, the machine could tap into a fairly broad market. He said he does not know how long the FDA review will take.
Silver said about 2 million women in the United States suffer from incontinence, or uncontrolled urination, as well as the inability to get out of beds or wheelchairs.
“The only other alternative out there now is diapers,” Silver said.
Davstar’s machine is made up of an absorbent pad connected to a tube that leads to a collection tub. The tub has a vacuum system that aids in collecting urine, Silver said.
As the general population ages, he said, the market for such a machine is likely to grow.
“There are a lot of people suffering out there,” Silver said. “Urinary incontinence is a significant cause of disability and dependence.”
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