NCC-PDI is one of 5 consortia funded by the Food and Drug Administration (FDA) to support pediatric gadget innovators in bringing more medical devices to market for kids. Pediatric medical device advancement continues to lag considerably behind that of adult devices.
The Childrens National team has developed an active clinical trials program and become a leader in translation of focused ultrasound for the treatment of pediatric strong tumors. The Pediatric Device Innovators Forum is a repeating collective educational experience developed by the FDA-supported pediatric device consortia and designed to connect and promote synergy amongst innovators across the innovation advancement community interested in pediatric medical gadget development.

If you have an interest in pediatric medical device development or alternative options to surgical treatment such as focused ultrasound, these two topics will merge at the Pediatric Device Innovators Forum, July 22, from 2– 3:30 p.m. This free livestream occasion, hosted by the National Capital Consortium for Pediatric Device Innovation (NCC-PDI), includes scientific, regulative and repayment experts discussing the subject “Focused Ultrasound for Pediatric Indications.”
NCC-PDI is a collaboration in between Childrens National Hospital and University of Maryland Fischell Institute for Biomedical Devices. NCC-PDI is one of five consortia funded by the Food and Drug Administration (FDA) to support pediatric gadget innovators in bringing more medical devices to market for kids. Pediatric medical device development continues to lag substantially behind that of adult gadgets.
Focused ultrasound is a noninvasive therapeutic innovation that uses an alternative to surgical treatment, radiation treatment, drug delivery and cancer immunotherapy. The technology has the potential to increase the lifestyle and reduce the cost of look after pediatric patients.
In 2015, Childrens National doctors ended up being the very first in the U.S. to use MR-HIFU to treat pediatric osteoid osteoma (OO), an uncomfortable, however benign, bone tumor that commonly happens in children and young adults. The Childrens National group conducted another clinical trial, led by pediatric oncologist AeRang Kim, M.D., Ph.D., to deal with relapsed soft tissue growths such as sarcomas.
In September 2020, the Focused Ultrasound Foundation designated Childrens National Hospital as the first international pediatric Center of Excellence for utilizing this technology to assist clients with specific types of childhood growths.
After gathering effective medical trial results at Childrens National, in November 2020, the FDA revealed the approval of Profound Medicals Sonalleve MR-HIFU system for the treatment of OO in the extremities. This marks the first focused ultrasound regulatory approval that will straight impact pediatric clients and the 6th indication to earn approval in the U.S. Nine patients were dealt with at Childrens National in a pilot trial designed to assess the safety and expediency of MR-HIFU ablation treatment in clients with agonizing OO. The treatment was performed without any technical problems or major negative occasions in all 9 clients and led to total discomfort relief without any more discomfort medication use in 8 out of nine clients.
The Childrens National group has constructed an active clinical trials program and end up being a leader in translation of concentrated ultrasound for the treatment of pediatric solid tumors. The latter provides an opportunity in pediatric care to deal with Diffuse Intrinsic Pontine Glioma (DIPG), an extremely aggressive brain growth.
Drs. Sharma and Packer will be among the medical, regulative and organization specialists speaking at the online forum. Program participants will also include Jessica Foley, M.D., chief scientific officer, Focused Ultrasound Foundation; Arjun Desai, M.D., chief tactical development officer, Insighttec; Arun Menawat, M.D., chairman and CEO, Profound Medical; Francesca Joseph, M.D., Childrens National; Johannes N. van den Anker, M.D., Ph.D., vice chair of Experimental Therapeutics, Childrens National; Gordon Schatz, president, Schatz Reimbursement Strategies; Mary Daymont, vice president of Revenue Cycle and Care Management, Childrens National; and Michael Anderson, M.D., M.B.A., F.A.A.P., F.C.C.M., F.A.A.R.C., senior consultant to US Department of Health and Human Services (HHS/ASPR) and Childrens National. The panel includes a special welcome by Sally Allain, local head of Johnson & & Johnson Innovation, JLABS @ Washington, DC.
The Pediatric Device Innovators Forum is a repeating collective instructional experience created by the FDA-supported pediatric gadget consortia and designed to connect and foster synergy among innovators across the technology development environment interested in pediatric medical gadget development. Each Forum is hosted by one of the five consortia. Register for this complimentary program today at pdiforum.org