Here’s the most recent example of why facilitating FDA’s Critical Path initiative is so crucial. FDA has granted initial clearance to AcryMed Inc. for a nanotechnology that can render existing medical devices impervious to infection-causing bacteria. The successful application of nantechnology is big news. The product, SilvaGard, can be used to treat virtually any medical device and its use does not alter the device’s original properties. The Centers for Disease Control estimates that 2 million U.S. patients a year acquire hospital-related infections. These infections cost an average of $47,000 per patient to treat and cause 90,000 deaths each year. The added cost to hospitals is $4.8 billion annually in extended care and treatment. The initial FDA clearance was given for marketing regional anesthesia delivery catheters. These devices are treated with a silver nanoparticle antimicrobial coating that protects against the formation of infection-causing biofilm. The devices can be treated to provide effective antimicrobial protection for days, weeks, or even months, depending upon application requirements.
Nano. Nano.
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