The agency granted its first approval order under the humanitarian device exemption in spinal pediatrics in the last 15 years.
The electrical nerve stimulator is intended to reduce functional abdominal pain in patients 11–18 years old.
The non-invasive trigeminal nerve stimulation system is intended for patients seven to 12 years old.
Developing medical devices in general is costly, but there is funding available for companies that are willing to create products specifically for pediatrics.
Most devices are still developed in a moment of need and not in advance like adult devices.
The 15-mm valve size is small enough to use in newborn patients to treat heart defects.
Companies developing technologies in pediatrics set to receive tens of thousands of dollars for their innovations.
Sometimes the beauty of innovation is in the simplicity of design.
Leveraging 3-D printing and injection molding, one team is developing a novel vaginal stent and dilator for a population that truly needs customized technology.
Six products received grants to help bring the devices to children faster.