MW Medical receives FDA clearance for new microwave applicator
Scottsdale, Arizona (ots-PRNewswire) -
MW Medical (OTC Bulletin Board: MWMD) received FDA clearance for its new, large aperture hair removal applicator. This accessory for the MW 2000 hair removal system provides a significantly larger treatment footprint to improve operator efficiency and increase treatment efficacy.
The clinical trial was performed in December, 2000 by Dr. David Duffy of Torrance, CA., under an IRB approved protocol with monitoring by MW Medical clinical personnel. After following patients for the prescribed period of the trial, the data was submitted to the FDA to support the 510(k) filing to begin marketing this new accessory. "We are indebted to Dr. Duffy and his staff for their interest in the project and quality of this study. Their dedication and diligence throughout the process was outstanding," states Tyler Brown, MW Medical COO.
Due to the nature of the accessory and the company's earlier approval, MW Medical requested and was granted a special 510(k) clearance. The trial was completed with one hundred percent compliance and zero adverse events. "This was truly an outstanding effort on all fronts -- the development team, Dr. Duffy and the clinical staff and our regulatory advisors -- all worked closely to make this project run flawlessly," stated Jan Wallace, MW Medical CEO. Regulatory Specialists of Irvine, CA. served as consultants to the company on the project and continue to support on-going clinical/regulatory development.
The new applicator's design also incorporates an improved energy distribution profile, increased efficiency and a new handle design. These features will provide more effective and efficient energy delivery to the hair follicles and a more comfortable design. This improves target heating while enhancing tissue cooling and reducing potential tissue damage at higher energy settings.
MW is particularly pleased with achieving this regulatory clearance, as it demonstrates the company's continuing objective to advance the use and safety of microwave technology in the medical field.
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