• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to footer
  • Advertise
  • Subscribe

MassDevice

The Medical Device Business Journal — Medical Device News & Articles | MassDevice

  • Latest News
  • Technologies
    • Artificial Intelligence (AI)
    • Cardiovascular
    • Orthopedics
    • Neurological
    • Diabetes
    • Surgical Robotics
  • Business & Finance
    • Wall Street Beat
    • Earnings Reports
    • Funding Roundup
    • Mergers & Acquisitions
    • Initial Public Offering (IPO)
    • Legal News
    • Personnel Moves
    • Medtech 100 Stock Index
  • Regulatory & Compliance
    • Food & Drug Administration (FDA)
    • Recalls
    • 510(k)
    • Pre-Market Approval (PMA)
    • MDSAP
    • Clinical Trials
  • Special Content
    • Special Reports
    • In-Depth Coverage
    • DeviceTalks
  • Podcasts
    • MassDevice Fast Five
    • DeviceTalks Weekly
    • OEM Talks
      • AbbottTalks
      • Boston ScientificTalks
      • DeviceTalks AI
      • IntuitiveTalks
      • MedtechWOMEN Talks
      • MedtronicTalks
      • Neuro Innovation Talks
      • Ortho Innovation Talks
      • Structural Heart Talks
      • StrykerTalks
  • Resources
    • About MassDevice
    • DeviceTalks
    • Newsletter Signup
    • Leadership in Medtech
    • Manufacturers & Suppliers Search
    • MedTech100 Index
    • Videos
    • Webinars
    • Whitepapers
    • Voices
Home » Mela shares double overnight after positive FDA review

Mela shares double overnight after positive FDA review

November 19, 2010 By MassDevice staff

MELA logo

Mela Sciences Inc.’s (NSDQ:MELA) stock doubled in price overnight after the a Food & Drug Administration panel voted in favor of its melanoma-detecting device’s safety and efficacy.

MELA shares were up 105.5 percent to $5.24 before the trading day opened. Through yesterday’s close, the shares lost 60 percent of their value in the past three months. The company’s shares’ gain remained around 95 percent up in mid-morning trading.

The FDA’s General and Plastic Surgery Devices Panel advisory panel recommended approval of the device on a narrow 8 to 7 vote. The review panel’s vote is non-binding, but the FDA often takes its cues from advisory panels in making final rulings omn pre-market approval applications. The vote comes two days after the release of a scathing internal FDA review of the Irvington, N.Y.-based company’s MelaFind device. The FDA said the device as a biopsy replacement may cause "more harm than good," and was not studied adequately and urged the company to run a new clinical trial.

Law firms were quick to pounce, announcing “investigations” of allegations that the company misled shareholders about the device.

The company’s shares tumbled to a low of $2.53 after the release of the negative review, down from a January peak of $12.24. MELA went public in 2005 for $5 per share.

Physicians testifying on behalf of the device at yesterday’s panel suggested that the MelaFind, which the company designed for early diagnosis of catch skin, would be a welcome addition to their cancer detecting tool kits.

Dr. Michael Newman, who participated in the first clinical trial for MelaFind, told the panelists that he’s a good dermatologist but not as good as the FDA would lead you to believe. He said he can use all the help he can get, according to The Street.

University of Pittsburgh dermatologist Dr. Laura Ferris, who also studied MelaFind for the company, told the panel that doctors like her “need help in evaluating these lesions.”

“The decision to biopsy is subjective, and it’s variable. Having an objective device to give me input on making that decision would be very helpful,” she said, according to Reuters.

The FDA has yet set a date for its decision on the MelaFind PMA application, according to the company.

Filed Under: Business/Financial News, Diagnostics, News Well, Oncology Tagged With: Dermatology, MELA Sciences Inc.

More recent news

  • EBR Systems raises $36.1M for leadless pacing tech
  • The biggest cardiovascular tech news out of EuroPCR 2025
  • CardiaWave has positive 12-month Valvosoft results
  • Elixir Medical reports sustained durability with bioadaptor compared to Medtronic stent
  • Medtronic has new Cardiovascular, CST leaders after longtime exec departs

Primary Sidebar

“md
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest med device regulatory, business and technology news.

DeviceTalks Weekly

See More >

MEDTECH 100 Stock INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
MDO ad

Footer

MASSDEVICE MEDICAL NETWORK

DeviceTalks
Drug Delivery Business News
Medical Design & Outsourcing
Medical Tubing + Extrusion
Drug Discovery & Development
Pharmaceutical Processing World
MedTech 100 Index
R&D World
Medical Design Sourcing

DeviceTalks Webinars, Podcasts, & Discussions

Attend our Monthly Webinars
Listen to our Weekly Podcasts
Join our DeviceTalks Tuesdays Discussion

MASSDEVICE

Subscribe to MassDevice E-Newsletter
Advertise with us
About
Contact us

Copyright © 2025 · WTWH Media LLC and its licensors. All rights reserved.
The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media.

Privacy Policy