Working with the Institute for Pediatric Innovation, Stanford School of Medicine and SRI International win a $1 million U.S. Food & Drug Administration grant for commercializing pediatric medical devices. The Food & Drug Administration awarded the MISTRAL Collaborative of SRI International and the Stanford University School of Medicine a $1 million grant to support the agency’s work to commercialize […]
The Institute for Pediatric Innovation Inc. added another health center to the consortium of healthcare providers its assembled to develop medical products for children. The Cambridge, Mass.-based institute tapped Children’s National Medical Center of Washington, D.C., for its collaborative of six health centers working to develop medical devices and pharmaceuticals specifically designed for infants and […]
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
The Food & Drug Administration will require medical device manufacturers to include information on the pediatric population that might be served by devices they’re seeking approval for from the agency. The requirement, which was part of the Food & Drug Administration Amendments Act passed in 2007, applies even to devices intended for use in adults. […]
Tim Moran still remembers hearing his prematurely born daughter scream when an adult-sized cannula was inserted in her mouth and taped to her face to deliver oxygen. Several years later, Moran has started PediaWorks, a not-for-profit organization that will work with medical professionals to develop pediatric medical devices, spinning off for-profit companies to commercialize those devices.
The Institute for Pediatric Innovation is developing two medical devices that will help doctors care for infants in neonatal intensive care units. Two children's hospitals in Ohio and California will provide end-user input on the design of the devices.