MELAFIND Lesion Imaging Technology a Step from Market Approval

September 26th, 2011 Ronney Shantouf Dermatology

MELA Sciences announced that the FDA has finally issued an approval letter for the MelaFind Pre-Market Approval application. The device is a non-invasive and objective multi-spectral computer vision system intended for use on clinically atypical pigmented skin lesions with one or more characteristics consistent with melanoma. Using a series of algorithms the system attempts to identify and classify the lesion. The device is to be used by appropriately trained physicians to help facilitate early detection of melanoma. MelaFind recently received European CE Marking earlier this month.

The company plans to work closely with the FDA to finalize pending issues such as physician labeling, user’s guide, and clinical protocols for post-approval study to obtain the final go ahead to bring the device to market.

Press release: MELA Sciences Receives Approvable Letter From FDA for MelaFind(R)

Flashback: MelaFind Lesion Imaging Device Receives CE Marking

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18octallday19alldayWorld Congress on Polycystic Ovarian Syndrome and Fertility, 2018Abu Dhabi, UAE

18octallday19alldayManaging Your Complaints and Obstacles in Post-Market Requirements -- Results from Top Medical Device Observations During an InspectionMinneapolis, MN, USA

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Post-Market activities, Complaint Handling, MDRs, and Recalls are expensive, time consuming, and often lead to more serious financial consequences. Over 80% of FDA Inspection target observations for lack of compliance in these areas.

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How to overcome one of the biggest obstacles device manufacturers face
How the FDA expects you to develop and implement proper handling of complaints reportable or non-reportable, product complaint handling and documentation
How and when to file Medical Device Reports (MDR), effective and appropriate communication with the appropriate regulatory agencies in the event of a recall.
How to conduct a correction and removal actions to avoid a recall crisis, including required recordkeeping, expectation from FDA and other regulatory agencies in the event of a recall and key factors in implementing and maintaining compliance with the regulations and real life experiences of FDA.

**New course materials have been added, updated content will include:

Creating Standard Operating Systems (SOPs) for Post-Market Quality Systems and
What to expect from the changes in ORA with Inspection Structure Realignment

This Seminar will have you stop spinning your wheels with nonessential activities, and leave you with a comprehensive learning package that only Rita Hoffman, a former FDA CDRH Recall Branch Chief with experience across the device, drug and veterinary industries can provide.

Spend one and a half days in an interactive course led by Ms. Rita Hoffman, Former FDA CDRH Recall Branch Chief with over 36 years with FDA and leading Industry Expert, who will provide the participants with tools to minimize risk of regulatory enforcement actions.

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october 18 (Thursday) - 19 (Friday)

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Compliance Online 80068SEM

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18octallday19allday18th Global Ophthalmology, Optometry and Glaucoma Conference, 2018Helsinki, Finland

18octallday19alldayBiology and Pathology of Infectious Disease Conference, 2018Helsinki, Finland

18octallday19allday14th Global Biomarkers Summit, 2018Amsterdam, Netherlands

22octallday23alldayInternational Conference on Breast Cancer, 2013Vancouver, British Columbia, Canada