The U.S. Food & Drug Administration releases a list of pre-market approvals granted in November 2011.
Below are Premarket Approvals (PMA), Product Development Protocols (PDP), Supplement and Notice Decisions. This list is generated on a monthly basis.
PMA Original Approvals
|APPLICATION NUMBER / DATE of APPROVAL||DEVICE TRADE NAME||COMPANY NAME CITY, STATE, & ZIP||DEVICE DESCRIPTION / INDICATIONS|
|MelaFind®||MELA Sciences, Inc.
|Approval for the MelaFind device. MelaFind is intended for use on clinically atypical cutaneous pigmented lesions with one or more clinical or historical characteristics of melanoma, excluding those with a clinical diagnosis of melanoma or likely melanoma. MelaFind is designed to be used when a dermatologist chooses to obtain additional information for a decision to biopsy. MelaFind should NOT be used to confirm a clinical diagnosis of melanoma.
MelaFind is only for use by physicians trained in the clinical diagnosis and management of skin cancer (i.e., dermatologists) who have also successfully completed a training program in the
appropriate use of MelaFind.
The MelaFind result is one element of the overall clinical assessment. MelaFind positive
lesions (which may include malignant melanoma, melanoma in situ, high grade dysplastic nevi
and atypical melanocytic proliferation/hyper-plasia) should be considered for biopsy; the biopsy
decision of a MelaFind negative lesion should be based on the remainder of the entire clinical context. Lesions that are "non-evaluable" by MelaFind should be carefully re-evaluated for biopsy.
MelaFind is indicated only for use on lesions with a diameter between 2 mm and 22 mm,
lesions that are accessible by the MelaFind imager, lesions that are sufficiently pigmented (i.e. not for use on non-pigmented or skin-colored lesions), lesions that do not contain a scar or
RECENT BLOG POSTS
InVivo hits the NASDAQ exchange
Shares of InVivo Therapeutics are slated to begin trading today on the NASDAQ stock exchange.
Abbott unveils over-the-counter glucose meter
Abbott Laboratories receives FDA approval for a new, budget-priced glucose monitor that can be...
Medtech investment in Minnesota falls back to earth
First-quarter investment in Minnesota's thriving medtech cluster falls back to earth after exploding...
EBR raises $20m for wireless pacer | Medtech funding for the week of April 13, 2015
Here's a look at some of the top legal news stories for medical device companies this week: EBR...
Renal denervation: Boston Scientific launches new Vessix trial
Boston Scientific launches a clinical trial of its Vessix renal denervation device in treating...
Top News Stories