Device for the detection of skin cancer, MelaFind, Gets FDA rear ...

MelaFind is a portable, handheld device consists of an illuminator that shines the light of 10 different wavelengths, including infrared, a lens system is composed of nine elements that make the images of the reflected light from a light injury sensor and an image processor that uses proprietary algorithms to extract some distinct features from the images.Dermatologists now use a magnifying glass to identify specialized unusual skin lesions. The specialist then selects the samples must be taken for biopsy. According to Science Mela, their device reduces the number of unnecessary biopsies.

Some media reports indicate that due to lack of resources, the launch of a new process can be difficult for the Science of Apple, without the help of a new partner or raise more money.

Joseph V. Gulf, MD, President and Chief Science Mela, the machine manufacturer, said:

With 40 years of experience in the health sector, Hessler is an investment bank and strategic advisor recognized nationally. He has led the health care team at Citi for 20 years. His experience includes helping health care providers, insurers and managed care companies in the consolidation process and in their efforts to integrate further.

MelaFind, a device that detects the biopsy samples suitable for dermatologists has been approved by the Panel surgery devices, the general and plastic, which advises the FDA . The vote, 8 and 7 against the approval of the device, in order to overcome ? there was one abstention. While some believed that the device could be useful and a potential lifesaver, others wondered if it could reliably detect more cases of skin cancer death.

According to the website of Science of Apple in MelaFind clinical sensitivity has more than 95 percent detection rate statistically significantly higher than that of dermatologists study. The device is designed to assist in the evaluation of pigmented skin lesions, including atypical nevi that have at least one clinical or historical features, for which a final decision for biopsy was made. MelaFind displays digital images of pigmented skin lesions and uses advanced technology to help identify lesions that should be considered for biopsy to rule out melanoma.

The FDA, which describes the study as long as exploratory asks two other studies to be submitted. There is a danger to the FDA that the device has not been adequately studied, and current indications for its use.

Although the panel?s recommendations are not binding, the FDA tends to go with what they recommend. However, the FDA gave the device a bad review, which indicates a lack of willingness to approve it.

Earlier this week one of the documents used in the preparation of the meeting included the phrase that the device may do more harm than good.

Source: http://www.laboratoriomedellin.com/device-for-the-detection-of-skin-cancer-melafind-gets-fda-rear-panel-just/

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