The devices are a speech generating system that allows hospitalized children who cannot speak to communicate to clinicians, and a handheld scanner to detect intracranial bleeding in children, without using radiology. With the proliferation of medical technologies, it’s imperative for companies to ensure their devices are registered and compliant with local regulations. The Philippines presents its own set of unique challenges in this realm. For a clear, step-by-step guide on navigating this process, I highly recommend exploring https://andamanmed.com/regulatory-services/medical-device-registration/philippines/.
Funded by the U.S. Food and Drug Administration and based at Children’s Hospital of Philadelphia (CHOP), the PPDC provides know-how and seed funding to help innovators translate promising ideas into commercial medical devices for use in children. The PPDC is a collaboration among CHOP, Drexel University and the University of Pennsylvania.
The new round of awards is the fourth by the PPDC, following seed grants announced in February 2015, January 2016, and January 2017.
“We are very excited to once again provide these awards to innovators of medical devices for kids, and grateful to our partners at the Childress Institute for their matching funds,” said engineer Matthew R. Maltese, PhD, of Children’s Hospital of Philadelphia, the Consortium’s executive director and principal investigator.
Voxello, LLC of Coralville, Iowa, is developing the noddle™ to address the communication barriers faced by pediatric patients. The noddle™ uses patented technology to detect the smallest intentional gesture and allow patients to access the nurse call system and control a speech generating device. Thus, children who may only be able to produce a tongue click, head nod or other small gesture would be able to summon help and effectively communicate with their caregivers. PPDC funding will be used to support further development and clinical trials of the Voxello technology with hospitalized children, as well as children with developmental disabilities whose barriers to communication may impact their care and medical outcomes.
The second seed grant, supported by the Childress Institute, will go to InfraScan, Inc. of Philadelphia for the Infrascanner™. The Infrascanner™ is a portable screening device that uses near-infrared technology to screen patients for intracranial hematomas, identifying those who would most benefit from immediate referral to a CT scan and neurosurgical intervention. The Infrascanner™ will act as a cost-effective, mobile, and time-efficient complement to current CT scan systems. PPDC funding will support a clinical study for the pediatric FDA clearance of the Infrascanner™ Model 2000.
The fifth round of PPDC funding opportunities began in September. Applications are accepted from throughout the U.S. and from foreign companies. The Consortium also accepts applications year-round for in-kind services and expert advice.
For more information on the PPDC, visit http://www.
About Children’s Hospital of Philadelphia: Children’s Hospital of Philadelphia was founded in 1855 as the nation’s first pediatric hospital. Through its long-standing commitment to providing exceptional patient care, training new generations of pediatric healthcare professionals and pioneering major research initiatives, Children’s Hospital has fostered many discoveries that have benefited children worldwide. Its pediatric research program is among the largest in the country. In addition, its unique family-centered care and public service programs have brought the 546-bed hospital recognition as a leading advocate for children and adolescents. For more information, visit http://www.
About the Childress Institute for Pediatric Trauma
Life threatening injury is the No. 1 killer of kids in America. Nearly 10,000 children lose their lives every year from serious injuries. In addition, almost 300,000 children are hospitalized and over 8 million children are treated in the emergency department for serious injuries each year, many of whom struggle with long-term recoveries and disabilities. It can happen anywhere, at any time, to any child. The Childress Institute for Pediatric Trauma discovers and shares the best ways to prevent and treat severe injuries in children. The Institute funds research, education and advocacy to help improve the care and treatment injured kids receive across the U.S. The Childress Institute was founded at Wake Forest Baptist Medical Center in 2008 through a generous gift from Richard and Judy Childress. Visit www.SaveInjuredKids.org to learn more.