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SRI International and Stanford University School of Medicine's MISTRAL Collaborative and the Institute for Pediatric Innovation Awarded FDA Grant to Accelerate Commercialization of Pediatric Medical Devices
Date:7/22/2010

MENLO PARK, Calif., July 22 /PRNewswire/ -- SRI International and the Stanford University School of Medicine announced today their MISTRAL Collaborative (the Multidisciplinary Initiative for Surgical Technology Research Advanced Laboratory), in conjunction with the Institute for Pediatric Innovation, was recently awarded a $1M grant by the Food and Drug Administration (FDA) to support its work to commercialize innovative medical devices for pediatric care.

A key objective for the FDA-funded project will be to identify opportunities for new medical devices specific to the newborn intensive care unit (NICU) setting. Other focus areas for pediatric product development will include surgical tools and catheter-related products.

"Children are the 'orphans' of the medical device industry," said Sanjeev Dutta, M.D., associate professor of surgery and of pediatrics at the Stanford University School of Medicine and attending surgeon at Lucile Packard Children's Hospital at Stanford. "Market and regulatory concerns often prevent medical device companies from investing in pediatric-specific device development. Not infrequently, appropriate devices that specifically address pediatric diseases are simply not available, leaving some practitioners to use adult devices on kids or 'jerry-rig' their own solutions. The MISTRAL Collaborative, with this tremendous boost from the FDA, hopes to catalyze pediatric device development by performing the initial R&D, partnering with industry, and identifying paths to market for badly needed pediatric devices."

There are a variety of reasons to explain the lack of appropriately developed medical devices for children. In addi
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SOURCE SRI International
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