by
Brendon Nafziger, DOTmed News Associate Editor | March 01, 2010
Still testing
But for the device to rule out the need for investigative biopsies and operations, it has to approach 90% accuracy, Eror says. Preliminary studies on the investigational device, which were presented last May at the American Thoracic Society's annual meeting, were promising and within that target range, according to Eror. "Competing technologies -- sputum cytology, breath analysis -- have not shown these kinds of results," he argues.
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Eror says Freshmedx plans to file with the Food and Drug Administration for approval by the end of the year. But the U.S. will likely be their second market, he says, as they have already completed CE mark testing, required for European approval, which they expect to get first.
Alternative markets
But to enter the market, the company is looking for partners with global distribution.
They also hope the device will prosper in alternative markets. Eror says that with additional successful clinical results, the device could be used in regions where CT scanners are scarce, such as developing countries or rural areas.
"We're initially interested in peripheral markets, a little off the beaten trail," Eror said.
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