• Roche Molecular Systems (Pleasanton, California) reported that Zelboraf (vemurafenib), a drug to treat patients with late-stage (metastatic) or unresectable (cannot be removed by surgery) melanoma, the most dangerous type of skin cancer. Zelboraf is specifically indicated for the treatment of patients with melanoma whose tumors express a gene mutation called BRAF V600E. The drug has not been studied in patients whose melanoma tests negative for that mutation by an FDA approved diagnostic. Zelboraf is being approved with a first-of-a-kind test called the cobas 4800 BRAF V600 Mutation Test, a companion diagnostic that will help determine if a patient's melanoma cells have the BRAF V600E mutation. The BRAF protein is normally involved in regulating cell growth, but is mutated in about half of the patients with late-stage melanomas. Zelboraf is a BRAF inhibitor that is able to block the function of the V600E-mutated BRAF protein. The FDA's approval of the cobas 4800 BRAF V600 Mutation Test was based on data from the clinical study that also evaluated the safety and effectiveness of Zelboraf. Samples of a patient's melanoma tissue were collected to test for the mutation.

• Syneron Beauty (Yokneam, Israel) has received FDA clearance to market the Tända Luxe Light Emitting Diode device to consumers. The new device is a next-generation evolution of the Tända Regenerate, and is cleared by the FDA for over-the-counter treatment of wrinkles, rhytides and fine lines around the periorbital (around the eye) region. The Tända Luxe wrinkle treatment device combines concentrated red light therapy, sonic vibration and gentle warming in a unique massaging treatment head to provide both the sensory and anti-aging benefits of a professional treatment. Tända Luxe's concentrated beams of red light therapy are delivered by a super-luminous LED array that produces a fractional phototherapy effect, effectively reversing signs of aging.