Electro-Optical Sciences Starts MelaFind Melanoma Detector Pivotal Study
This article was originally published in The Gray Sheet
Executive Summary
Electro-Optical Sciences anticipates PMA approval in 2008 for its MelaFind hand-held melanoma detector, supported by a pivotal trial initiated the week of Jan. 29
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Electro-Optical Sciences’ MelaFind melanoma detector
Firm files PMA application June 4 for use of the handheld, non-invasive device to assist in the early diagnosis of melanoma, the leading cause of death from skin cancer. The PMA is supported by pivotal trial data showing 95% sensitivity, with specificity "statistically significantly higher than that of study clinicians," according to the company. While dermatologists typically diagnose melanoma with their naked eyes, MelaFind uses 10 different wavelengths of light to analyze skin lesions and help clinicians decide whether to perform a biopsy. FDA granted the PMA "expedited review" status while it was still in the planning stages in October 2006; the agency grants expedited review - placing the PMA at the head of the pre-market review queue - in cases where "a device offers a potential for clinically meaningful benefit as compared to the existing alternatives ... or when the new medical device promises to provide a revolutionary advance," according to FDA (1"The Gray Sheet" Feb. 5, 2007, p. 15)
Electro-Optical Sciences’ MelaFind melanoma detector
Firm files PMA application June 4 for use of the handheld, non-invasive device to assist in the early diagnosis of melanoma, the leading cause of death from skin cancer. The PMA is supported by pivotal trial data showing 95% sensitivity, with specificity "statistically significantly higher than that of study clinicians," according to the company. While dermatologists typically diagnose melanoma with their naked eyes, MelaFind uses 10 different wavelengths of light to analyze skin lesions and help clinicians decide whether to perform a biopsy. FDA granted the PMA "expedited review" status while it was still in the planning stages in October 2006; the agency grants expedited review - placing the PMA at the head of the pre-market review queue - in cases where "a device offers a potential for clinically meaningful benefit as compared to the existing alternatives ... or when the new medical device promises to provide a revolutionary advance," according to FDA (1"The Gray Sheet" Feb. 5, 2007, p. 15)
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Amedica cancels IPO plan: Orthopedic implant maker Amedica cancels plans for an initial public offering, citing adverse stock market conditions in an Aug. 1 statement. The firm says its cash position is "adequate" to continue preparations for a 2008 U.S. market debut of its initial Valeo silicon nitride ceramic spinal implant, and that it will pursue additional financing at an "appropriate" time in the future (1"The Gray Sheet" June 4, 2007, p. 7)...