Medtech Insight is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

Spectral Molecular Imaging Readies IDE For Melanoma Detection Trial

This article was originally published in The Gray Sheet

Executive Summary

Spectral Molecular Imaging will submit an investigational device exemption application to FDA within three months for its SkinSpect system to aid early melanoma detection.

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)

US Q1 Consumer Health Earnings Preview: Label This One Historic And Challenging But Promising

US OTC drug and supplement firms’ reports of results for the first three months of 2024 began on April 19 with P&G. JP Morgan analysts say while “some retailers in the US in particular” are reducing consumer health inventories, for the overall sector they expect “a healthier balance of positive volume and lower pricing contribution.”

Keeping Track: Cancer Approvals From Lumisight Imaging To Adjuvant Alecensa

The US FDA’s approval of Lumicell’s optical imaging agent Lumisight makes a dozen novel approvals in 2024 for the Center for Drug Evaluation and Research.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

MT029510

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

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