Showing 551-560 of 1351 results for "".
- Health Canada Clears Cutera’s AviClearhttps://practicaldermatology.com/news/health-canada-clears-cuteras-aviclear/2461268/Health Canada has cleared Cutera, Inc.’s AviClear for the treatment of mild, moderate, and severe acne. This Health Canada announcement comes on the heels of the U.S. Food and Drug Administration’s 510(k) clearance of AviClear, in March 2022. In addition
- DERMWIRE Exclusive: FDA Clears Cutera’s AviClear Acne Devicehttps://practicaldermatology.com/news/dermwire-exclusive-fda-clears-cuteras-aviclear-acne-device/2461124/The U.S. Food and Drug Administration has cleared granted 510(k) clearance to Cutera’s AviClear acne device. This is the first energy device to receive a nod for the treatment of mild, moderate, and severe acne. AviClear targets acne at the source by selec
- Lilly's Lebrikizumab Plus Topical Corticosteroids Offer Improvement and Itch Relief in Atopic Dermatitishttps://practicaldermatology.com/news/lillys-lebrikizumab-plus-topical-corticosteroids-offer-improvement-and-itch-relief-in-atopic-dermatitis/2461015/Lebrikizumab, an IL-13 inhibitor, significantly improved disease severity when combined with topical corticosteroids (TCS) in people with moderate-to-severe atopic dermatitis (AD) in Eli Lilly and Company's third pivotal Phase 3 trial (ADhere). By Week 16, the study met all primary and k
- FDA: Omeza's Collagen Matrix Cleared for Marketinghttps://practicaldermatology.com/news/fda-omezas-collagen-matrix-cleared-for-marketing/2460904/The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to the Omeza Collagen Matrix for chronic wound care. Omeza Collagen Matrix (OCM) is a wound care matrix comprised of hydrolyzed fish collagen infused with cod liver oil, which acts as an anhydrous skin pr
- It's a RAP: Allergan Set to Acquire Solitonhttps://practicaldermatology.com/news/deal-time-allergan-set-to-acquire-soliton/2460801/Allergan Aesthetics is set to acquire Soliton and Resonic, its Rapid Acoustic Pulse device. Resonic recently received U.S. Food and Drug Administration (FDA) 510(k) clearance and is a non-invasive treatment for the short-term improvement in the appearance of cellulite. The ac
- FDA Nod for Modifications to Soliton's Resonic Devicehttps://practicaldermatology.com/news/fda-nod-for-modifications-to-solitons-tattoo-removal-device/2460790/The U.S. Food and Drug Administration granted Soliton, Inc. 510(k) for modifications to its RESONIC device. The RESONIC device utilizes the RAP technology to deliver safe and effective tattoo removal and cellulite treatment and now includes an autoloading cartridge and an
- Study: Pembrolizumab Provides Long-Term Benefits in Patients With Metastatic Melanomahttps://practicaldermatology.com/news/study-pembrolizumab-provides-long-term-benefits-in-patients-with-metastatic-melanoma/2460470/A new 10-year analysis provides new insights into an important question: whether BRAF V600E/K mutation status or previous BRAF inhibitor (BRAFi) therapy with or without a MEK inhibitor (MEKi) affects response to pembrolizumab (Keytruda). This retrospective analysis of three ra
- Soliton Seeks 510k Clearance for RAP Anti-Cellulite Devicehttps://practicaldermatology.com/news/soliton-seeks-510-clearance-for-rap-anti-cellulite-device/2460452/Soliton, Inc. filed for 510(k) premarket clearance with the U.S. Food and Drug Administration (FDA) of its second-generation Rapid Acoustic Pulse (RAP) device for the reduction in the appearance of cellulite. The RAP device was previously cleared by the FDA as an accessory to a 1064 nm
- Wontech Scores FDA Nod for Sandro Dual Laserhttps://practicaldermatology.com/news/wontech-scores-fda-nod-for-sandro-dual-laser/2460333/The U.S. Food and Drug Administration granted 510 (K) marketing clearance to Wontech’s Sandro Dual, a hybrid Nd:YAG & Alexandrite laser device. In the hybrid mode, by irradiating a short time difference between two wavelengths of 755nm and 1064nm, the laser accurately hits its
- FDA Clears Sebacia Microparticles for Laser-Based Acne Treatmenthttps://practicaldermatology.com/news/fda-clears-sebacia-microparticles-for-laser-based-acne-treatment/2457603/Sebacia Microparticles are now FDA-cleared for use in the treatment of acne. The clearance comes on the heels of a pivotal study demonstrating the clinical safety and efficacy of the micoparticles. Sebacia, Inc. had submitted its 510(k) submission to the FDA in June 2018. Sebacia Mic