Lesson plan
Melafind
MelaFind is a discontinued medical device developed by MELA Sciences, based in Irvington, NY. It was the first dermatological AI device to receive approval by the FDA. MelaFind is a non-invasive tool that provides additional information to dermatologists during melanoma skin examinations. The device uses light from visible to near-infrared wavelengths to evaluate skin lesions up to 2.5 mm beneath the skin. The device provides information on a lesion's level of morphologic disorganization to provide additional objective information that may be used by dermatologists in the biopsy decision-making process. MelaFind received CE Mark approval in November 2011 and is approved for use in the European Union. MelaFind received approval from the US Food and Drug Administration in November 2011 for use in the US. MelaFind was listed as one of the Top 10 Medical Innovations for 2013 compiled by the Cleveland Clinic and received a bronze Edison award for its innovation. The MelaFind pivotal study was the largest positive prospective clinical study ever conducted in melanoma detection with 1,384 patients presenting 1,831 skin lesions. This study aimed to establish the safety and effectiveness of MelaFind using sensitivity and specificity as metrics. The device demonstrated 98.3% sensitivity by correctly identifying 172 out of 175 melanomas and high-grade lesions.…
Article summary
MelaFind is a discontinued medical device developed by MELA Sciences, based in Irvington, NY. It was the first dermatological AI device to receive approval by the FDA. MelaFind is a non-invasive tool that provides additional information to dermatologists during melanoma skin examinations. The device uses light from visible to near-infrared wavelengths to evaluate skin lesions up to 2.5 mm beneath the skin. The device provides information on a lesion's level of morphologic disorganization to provide additional objective information that may be used by dermatologists in the biopsy decision-making process. MelaFind received CE Mark approval in November 2011 and is approved for use in the European Union. MelaFind received approval from the US Food and Drug Administration in November 2011 for use in the US. MelaFind was listed as one of the Top 10 Medical Innovations for 2013 compiled by the Cleveland Clinic and received a bronze Edison award for its innovation. The MelaFind pivotal study was the largest positive prospective clinical study ever conducted in melanoma detection with 1,384 patients presenting 1,831 skin lesions. This study aimed to establish the safety and effectiveness of MelaFind using sensitivity and specificity as metrics. The device demonstrated 98.3% sensitivity by correctly identifying 172 out of 175 melanomas and high-grade lesions.…
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Discussion questions
- Summarise the article in your own words. Which single claim would you verify first, and why?
- Which claim in this article is most likely to be revised as the sources update? How would you check its current status?
- If two sources disagreed about one of these facts, what would you need in order to trust one over the other?
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