Medtech Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

Regulatory News In Brief

This article was originally published in The Gray Sheet

Executive Summary

Mela Sciences panel delay: FDA has postponed advisory committee review of Mela Sciences' MelaFind, a non-invasive computer vision system to aid in the detection of melanoma, from Aug. 26 to sometime in November. FDA told the firm it needs more time to arrange the meeting, the firm said July 21 (1"The Gray Sheet" June 28, 2010)

You may also be interested in...



Mela Sciences' MelaFind goes to panel

FDA's General and Plastic Surgery Devices advisory panel will meet Nov. 18 to discuss a pre-market approval application for Mela Sciences' non-invasive computer vision system to aid in the detection of melanoma. The computer-controlled multi-spectral dermoscope uses light to image skin through a thin layer of liquid, making lesions under the skin surface visible to the eye; a digital camera inside the probe captures images and differentiates lesions for melanoma risk using pattern recognition software. The panel review was postponed from Aug. 26 to allow FDA more time to arrange the meeting (1"The Gray Sheet" July 26, 2010)

Mela Sciences' MelaFind goes to panel

FDA's General and Plastic Surgery Devices advisory panel will meet Nov. 18 to discuss a pre-market approval application for Mela Sciences' non-invasive computer vision system to aid in the detection of melanoma. The computer-controlled multi-spectral dermoscope uses light to image skin through a thin layer of liquid, making lesions under the skin surface visible to the eye; a digital camera inside the probe captures images and differentiates lesions for melanoma risk using pattern recognition software. The panel review was postponed from Aug. 26 to allow FDA more time to arrange the meeting (1"The Gray Sheet" July 26, 2010)

Regulatory News In Brief

Array-based cytogenetic tests: The Cleveland Clinic and the College of American Pathologists disagree on whether cytogenetic diagnostic arrays are ready for prime time, according to July 30 comments to FDA. The agency is carving out a regulatory policy for the complex assays, which detect DNA copy number changes that may indicate disease (1"The Gray Sheet" July 12, 2010). Cleveland Clinic 2cautions that "our current ability to conduct array-based cytogenetic tests exceeds our understanding of the pathophysiology behind some of these findings." Labs should standardize test interpretation and reporting approaches, the clinic writes, and results should be presented by a genetic counselor. The college of pathologists, on the other hand, says the tests "are not unlike numerous other laboratory tests" used today and should not be "unduly restricted" by FDA. "Patient care is compromised when diagnostic testing services are less readily and affordably available because of burdensome regulation," CAP 3writes. The group suggests databases and criteria that could be used to distinguish benign from pathogenic test findings

Related Content

Topics

UsernamePublicRestriction

Register

MT029180

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel