Move Signals KCI’s Support of FDA’s Goal of Ensuring Strong Standards for Patient Home Use
SAN ANTONIO--(BUSINESS WIRE)-- Kinetic Concepts, Inc. (NYSE: KCI) today announced it is the first manufacturer to commit to submitting labeling for its products used in the home to the Food and Drug Administration as part of the agency’s medical device Home Use Initiative. KCI will voluntarily submit labeling for its products cleared by FDA for home use for inclusion in the home use device labeling repository on the FDA’s website.
As home-based care becomes more prevalent and sophisticated, the FDA is stepping up efforts to ensure complex medical devices have the safeguards needed for safe home use by patients. As part of the initiative, the FDA is launching a 10-month pilot program beginning this summer in which manufacturers of home use devices may voluntarily submit their labeling for posting on a central website repository. The repository will provide a central location for home care patients and caregivers to access important information about the safe use of their devices.
“Patient safety means everything to KCI, and we support the FDA in launching its initiative,” said Catherine Burzik, KCI’s president and CEO. “We not only commit to take this important and needed step, but believe in the FDA’s broad goal of putting patients and safety first. The people of KCI — on behalf of caregivers and patients — look forward to working with the administration to aid this important endeavor.”
KCI’s ActiV.A.C.®, InfoV.A.C.®, V.A.C. Freedom®, V.A.C. ATS® and V.A.C.Via™ Therapy Systems were 510(k) cleared with an indication for home use based on substantial clinical and scientific data. Additionally, the company trains almost 50,000 clinicians on V.A.C.® Therapy usage annually. The company also provides 24/7 phone support line where patients can access staff clinicians.
About KCI
Kinetic Concepts, Inc. (NYSE:KCI) is a leading global medical technology company devoted to the discovery, development, manufacture and marketing of innovative, high-technology therapies and products for the wound healing, tissue regeneration and therapeutic support system markets. Headquartered in San Antonio, Texas, KCI’s legacy spans more than three decades and is rooted in a passion for healing wounds and restoring lives around the world through innovative, clinically proven therapies. The Company employs 6,800 people and markets its products in 20 countries. For more information about KCI, and how its products are changing the practice of medicine, visit www.KCI1.com.
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INDUSTRY KEYWORDS: Surgery Health Biotechnology Hospitals Medical Devices Other Health FDA Medical Supplies Nursing Managed Care
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