Cytomedix, Inc, Rockville, MD, has received Food and Drug Administration (FDA) marketing clearance for its AutoGel System. The platelet-rich plasma (PRP) gel is indicated for use on exuding wounds, such as leg, pressure, and diabetes-related ulcers, and for the management of mechanically or surgically debrided wounds. Cytomedix is the first company in the United States to complete a randomized, controlled, multicenter, double-blinded clinical trial for a PRP gel system for use on chronic wounds, according to the company. The AutoGel System is currently the only autologous platelet gel therapy product with FDA clearance for a broad indication that includes various types of chronic wounds.
Sage Products, Cary, IL, announced that its Skin Check system for promoting daily skin inspection is now available on all of its prepackaged Comfort Bath products at no extra charge. The easy-to-use, peel-and-stick label empowers nonlicensed staff to observe and communicate skin issues to the patient's nurse by indicating which part of the body needs to be checked for skin problems. The gentle, rinse-free Comfort Bath washcloths provide a hygienic and cost-effective alternative to soap and water bathing, and minimize the chance of cross contamination, according to the company.
Sage Products also has been awarded a new technology agreement from Novation, LLC, Irving, TX, for its 2% chlorhexidine gluconate (CHG) cloths, effective July 1, 2007, through June 30, 2010. Products containing 2% CHG are US Food and Drug Administration approved for preoperative skin preparation.
Medela, Inc, Chicago, IL, has been awarded accreditation status by the Accreditation Commission for Health Care, Inc, (ACHC). The ACHC is a private, not-for-profit corporation that is certified to ISO 9001:2000 standards and was developed by home care and community-based providers to help companies improve business operations and quality of patient care. Medela's completion of the accreditation process positions the company to provide its Invia Healing System to the negative pressure wound therapy market, according to Medela.
Diversified Clinical Services, Jacksonville, FL, has appointed Jeffrey W. Nelson as President and Chief Executive Officer. Jim Henry, who has served as CEO since 1997, will transition to the role of Vice Chairman of the Board. Mr Nelson has more than 20 years' experience in the health care industry and stated that he is excited to join Diversified Clinical Services, which is a national wound care company that collaborates with hospitals to establish and manage comprehensive outpatient wound care programs.