- Optiscan Imaging has rounded off a string of positive business dealings with an appointment with the Food and Drug Administration (FDA)
- The meeting will be held in January 2020 to discuss an application for marketing Optiscan’s “ViewnVivo” system in America
- ViewnVivo uses laser scanning imaging to read a patient’s tissue and screen for oral cancer and tumours
- The intended submission with the FDA could take a matter of months or years
- Shares Optiscan increased in value by 5.13 per cent to trade at 4.1 cents each
Optiscan Imaging (ASX:OIL) has earned the spot to discuss its cancer screening technology with the Food and Drug Administration (FDA) early next year.
The meeting discusses Optiscan’s “ViewnVivo” system which is engineered to screen specifically for oral cancer and tumours.
Optiscan is currently seeking to submit its “510(k)” application to the FDA. The 510k submission is necessary when seeking to market a product for human application in the U.S.
The ViewnVivo system uses laser scanning imaging to assess the patient’s tissue in the mouth — helping to screen for signs of oral cancer.
Optiscan Executive Chairman Darren Lurie spoke today on the company’s ongoing successes.
“It is pleasing to see the positive developments across all areas of the business, including progress with regulatory aspects of our own clinical system, our orders from CZM and the early impact of our new China distributor model,” he said.
CZM is German based medical technology company Carl Zeiss Meditec. CZM recently ordered $550,000 worth of products from Optiscan.
Last month, Optiscan appointed scientific equipment company Guangzhou Yunxing to distribute its solutions in China.
FDA 510(k) applications can take a matter of months, or years. Optiscan initially lodged its request to meet with the FDA on November 4.
“These initiatives have been some time in the making and it is rewarding to see them starting to come to fruition,” Darren said in conclusion.
Shares Optiscan increased in value by 5.13 per cent to trade at 4.1 cents each.