News
Indoor Tanning Industry Spokesperson Available for Comment to the Media
WHAT: U.S. Representatives Carolyn Maloney (D-NY) and Charles Dent (R-PA) are introducing legislation called the Tanning Bed Cancer Control Act on Tuesday, January 26, 2010.
Study Suggests Artefill® Is As Safe as Other Dermal Fillers
Suneva Medical, a privately-held aesthetic medical device company, today announced 18-month interim results from its prospective, open-label, five-year safety and patient satisfaction study on Artefill for nasolabial fold (NLF) correction. The study assessed adverse events with Artefill starting at 6-months post treatment. Initial results show the incidence of adverse events with Artefill compare favorably to the current label, and that the majority of patients (88%) reported a high satisfaction rating. Upon completion, this will be the largest and longest duration prospective U.S. clinical study of any dermal filler.
Reduce Body Fat Using Cryolipolysis
Zeltiq, a liposuction alternative, is a non-surgical way to reduce unwanted body fat using a patented cooling technique (cryolipolysis) that reduces the number of living fat cells. Unlike liposuction, the Zeltiq procedure is non-invasive, and does not require incisions or injections. No anesthesia is required for the Zeltiq procedure.
Plastic Surgery Market Provides Growth Opportunities
Frost & Sullivan has recently completed a global survey of hospitals and surgery centers providing plastic surgery. The survey, Growth Opportunities in the Global Plastic Surgery Market, reveals that plastic and cosmetic surgery continues to post some of the strongest procedural growth year-over-year of any surgical specialty. This detailed, quantitative, global assessment finds significant growth in select procedures and shows how opportunities vary widely by country.
Eleme Medical Announces The Real Women of SmoothShapes® Campaign
Eleme Medical Inc., premier aesthetics company and leader in the body shaping market, announced today that they will be conducting a global contest to select cellulite patients to be The Real Women of SmoothShapes. An alternative to celebrity endorsement, the campaign's objective is to promote the most preeminent success stories from real women who experienced SmoothShapes cellulite and BodySlimming™ treatments, letting the results speak for themselves so that people can relate to them - and the treatment - better.
FDA Requires Sybaritic, Inc. to Stop Producing Unapproved Medical Devices
Sybaritic Inc., a medical device maker, has agreed to stop producing and distributing its medical products used in laser surgery, dermatology, and spa treatments until it is in compliance with FDA quality standards. The products are considered to be unapproved medical devices as they lack appropriate FDA clearance review and approval for safety and effectiveness. The agreement was part of a consent decree of injunction signed by Bloomington, Minn., company and three of its top executives, Anthony S. Daffer, Steven J. Daffer, and Ronald Berglund.
PhotoMedex and Galderma to Co-Promote Actinic Keratosis Treatment
PhotoMedex and Galderma Laboratories, L.P. have entered into a co-promotion agreement for Galderma’s photodynamic therapy application for the treatment of actinic keratoses (AK). Under the terms of the agreement, PhotoMedex sales force will promote Galderma’s drug Metvixia® (methyl aminolevulinate) Cream, 16.8% (Metvixia) and Galderma’s Aktilite® CL128 LED (light-emitting diode) lamp to healthcare professionals, including dermatologists, plastic surgeons and cosmetic surgeons throughout the United States. Galderma will provide marketing support and distribution. The three-year agreement begins in January; no financial terms have been disclosed.
Excaliard Initiates Phase 2 Trials
Excaliard Pharmaceuticals, Inc. announced today the initiation of three proof of concept Phase 2 trials of EXC 001, an antisense medicine that reduces fibrosis, for the amelioration of skin scarring and other fibrotic disorders. The U.S. multicenter trials will test the efficacy, safety, and tolerability of EXC 001 in two different models to evaluate the improvement of the appearance of scars in subjects undergoing elective abdominoplasty surgery and revision of scars associated with prior breast surgery.
Levia® Receives FDA 510 (k) Clearance
Lerner Medical Devices, Inc. announced today that Levia®, a novel, in-home, ultraviolet B (UVB) phototherapy device, has received 510 (k) clearance from the U.S. Food and Drug Administration (FDA) for treatment of psoriasis and certain other skin conditions such as vitiligo. Under the direction of a physician, Levia enables patients to treat privately their chronic scalp and small area psoriasis with a convenient, safe and effective non-drug option: Personal Targeted Phototherapy™.
FDA: Safety Labeling Changes for Humira (adalimumab) injection
Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, of which HUMIRA is a member.