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Sunday, September 13, 2009

FDA calender

On 5/26/09, iCAD Inc. (NASDAQ:ICAD) ($1.23) announced it submitted data to the FDA seeking 510(k) marketing clearance of its VeraLook computer-aided detection (CAD) technology for CT colonography (CTC), or “virtual” colonoscopy. iCAD’s VeraLook product uses advanced algorithms to detect and highlight potential polyps warranting closer review by a radiologist. VeraLook has the potential to reduce oversight errors that could occur during review of a virtual colonoscopy exam, due to the large number of images (approximately 1500) generated by the CT system. By incorporating CAD with virtual colonoscopy, radiologists can use an image analysis tool that detects and marks potential polyps in an effort to improve detection of pre-cancerous polyps. VeraLook technology is currently available in Europe.

JUN 15, 2009
BioElectronics Corp. (BIEL) announced the filing an application with the FDA for 510(k) clearance to market its Allay(TM) Menstrual Pain Relief Patch product.

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Typically the FDA has 90 days (their policy) from the date they recieve the application to make a decision, provided they do not need additional information. Considering the FDA's decision for NEPH was about 30 days late, we can probably expect the same for BIEL. I personally don't expect a decision till October.

1 comment:

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