Syneron(TM) Medical Ltd. has launched the sleek eMatrix(TM) treatment system, a portable touch-screen device that allows physicians to program dermatological procedures requiring skin resurfacing. An exciting advancement in aesthetic procedure technology that helps physicians to treat more patients in more locations, eMatrix utilizes Matrix RF(TM), the world’s first RF-only technology for fractional ablation and skin resurfacing, which was FDA-cleared and received the CE Mark for wrinkle reduction in August. The new eMatrix system uses fractional tissue heating to provide ablation and effective resurfacing.

Johnson & Johnson Pharmaceutical Research & Development has announced that it received a Complete Response letter from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for ceftobiprole for the treatment of complicated skin and skin structure infections, including diabetic foot infections. The FDA has indicated that they cannot approve the NDA for ceftobiprole at this time. They have asked J&JPRD to conduct additional audit work of clinical investigator sites and to address specific questions related to site monitoring.

The U.S. Food and Drug Administration has approved updated labeling changes for Genentech Inc.’s Raptiva (efalizumab) to warn of  the dangerous infection risks (like PML) associated to its usage. A once-weekly injection, Raptiva is approved for treatment of plaque psoriasis in adult candidates for phototherapy or systemic (whole body) therapy. Also, a risk of immune system’s permanent suppression with repeated administration of Raptiva has been indicated for kids below 14 years.

The U.S. Food and Drug Administration has given 510(k) clearance to Reliant Technologies Inc. for three novel Fraxel re:pair laser hand pieces. This enhanced potential of the Fraxel re:pair laser system will provide physicians with an option for surgical treatment and skin resurfacing. As part of the Fraxel re:pair Complete Fractional Ablative Workstation, all of the three surgical hand pieces can be used alone or along with each other, with no need to turn the system off for changing the hand pieces.

The U.S. FDA has approved EVOLENCE for the correction of moderate to deep facial wrinkles and folds, such as nasolabial folds. EVOLENCE is a new generation collagen-based structural dermal filler. Its introduction marks the first dermal filler entry for the Aesthetics Group of OrthoNeutrogena. Collagen, comprising up to 80% of the dermis, forms natural and abundant building blocks that help the skin to maintain its strength. As one becomes older, collagen naturally breaks down and the face is full of wrinkles, lines and folds.

EVOLENCE and its proprietary GLYMATRIX Technology use collagen from natural sources to compensate for the lost collagen in the body. This adds volume and structural support in depleted areas, for a more naturally youthful appearance. There is no need of any pre-test, but the durability assured is unparallelled.

According to Medicis Pharmaceutical, the FDA’s waiver provisions for the generic versions of the company’s once-daily oral acne drug, Solodyn (minocycline HCl), will put patients at risk. The company is asking the FDA to approve Solodyn’s generic versions only after in vivo bioequivalence testing for drug strength.

The FDA has granted clearance to Cynosure’s TriActive LaserDermology System, which is a cellulite treating system based on laser. In addition to the system’s apparent effect on cellulite, it also relives patients of minor pain and muscle spasms. TriActive LaserDermology System improves circulation as well and can be used with various plastic surgery procedures.

The Food and Drug Administration (FDA) has approved a drug that reverses the numbing effects of local anesthesia used by dentists. OraVerse, which was developed by Novalar Pharmaceuticals Inc. is the first dental anesthesia reversal agent on the market for patients of age 6 years or more. According to clinical studies, OraVerse reduces the time it takes for the effect of Novocaine and other numbing agents to wear off to half. Novalar aims to start selling the product in October.

Reliant Technologies has received FDA approval for its 510(k) submission for its Fraxel repair laser system for Fractional Deep Dermal Ablation (FDDA™) treatment. The system is used for treating wrinkles, rhytides, furrows, fine lines, textural irregularities, pigmented lesions and vascular dyschromia. The Fraxel repair laser system already had clearance for ablation, coagulation and skin resurfacing.