Impact1 at Stanford Biodesign

💥 Announcing the i4KIDS-EUROPE Hospital Challenge based Programme Call! 🌍 We're excited to launch the #i4KIDSEUROPE Hospital Challenge based Programme, open to startups, innovators and companies focused on developing innovative solutions for unmet needs in paediatrics. 👶👧👦 Following a needs assessment conducted by #i4KIDSEUROPE and ECHO - European Children's Hospitals Organisation member hospital representatives, the following Key Challenges have been selected for this call:  1️⃣ Improving clinical workflows ➡️ Reducing the administrative burden on clinicians to focus on patient care. 2️⃣ Monitoring high-risk medications ➡️ Ensuring safe medication practices for paediatric patients. 3️⃣ Appointment efficiency ➡️ Minimising missed appointments to improve patient outcomes. ✅ Are you an established company with an innovative solution to one of these issues?  ✅ Do you have a technology-based project that can be easily integrated and scaled across communities and regions in Europe? We invite you to apply by 🗓️ 11 August 2024!!!  Selected projects will compete at the Paediatric Innovation Day in Riga on 27 September 2024 and the winner will have the opportunity to start a pilot project in one of the #i4KIDSEUROPE Hospitals.🚀 Find out more and apply: https://lnkd.in/dpgHDX79 ✨ Help us spread the word about this call to your contacts!  EIT Health Spain -  Hospital Sant Joan de Déu Barcelona - HUS Helsingin yliopistollinen sairaala -  Inveniam Group -  Bērnu klīniskā universitātes slimnīca -   Fundació de Recerca Sant Joan de Déu -  Fundacja K.I.D.S. | Klub Innowatorów Dziecięcych Szpitali | - Rigshospitalet Innovation - Mary Elizabeths Hospital - Riget for børn, unge og gravide   #i4KIDSEUROPE #i4KIDS #HospitalChallengeProgramme #paediatricinnovation #healthcareinnovation #EUInnovation #childrenhealth #startups #Innovation #InnovationHealthcare #Healthcare #Paediatrics #PaediatricInnovation #PediatricInnovationDay2024

The FDA has published their draft guidance for improving patient diversity in clinical studies by requiring sponsors to submit Diversity Action Plans (DAP). The public comment period is now open. Two components that stand out to me so far: 1. A device-related DAP seems optional (language switches to 'should') for pre-submission discussion but is again required (language back to 'must') for a device’s premarket notification (510(k)), PMA application, or De Novo classification request. By that point - sponsors are likely justifying the work they already completed as opposed to discussing potential adjustments to the studies ahead. Meanwhile, the drug DAPs are required alongside the protocol plan for phase 3 studies. Perhaps this is due to the wider variations in study requirements & designs in the device world compared to drugs, but I think device DAP requirements versus recommendations deserve further consideration. 2. Pediatric populations are mentioned briefly, but not deeply discussed. I wonder if DAPs for devices could potentially be used in a way similar to PREA in drugs to promote more consideration of pediatric patients. Full guidance and comment submission link: https://lnkd.in/gUtjCVCC

I am proud to announce that we treated our first pediatric patient with the Eclipse XL1 System for intestine lengthening. The patient was a 2 year-old-boy struggling with Short Bowel Syndrome (SBS). We are hopeful that this exciting technology will help him and many more patients like him in the future. A huge CONGRATULATIONS goes out to Dr James Dunn (inventor) on this major accomplishment. Here are a few words from Dr Dunn on the case... (Note: This was an expanded use of the Eclipse XL1, an investigational medical device currently being studied to evaluate safety and effectiveness.)

Did you know that drug overdose is now the third leading cause of death for U.S. adolescents? To tackle this challenge, a recent concept accepted by the advisory council of the The National Institute on Drug Abuse (NIDA), has inspired the FDA-funded Alliance for Pediatric Device Innovation (APDI), led by Children's National Hospital, to open an RFP seeking proposals from device innovators to develop medical devices to monitor, diagnose and treat youth suffering from substance use disorder and addiction.   In addition to receiving funding from APDI, successful applicants will receive technical assistance from The National Institute on Drug Abuse (NIDA) and prepare for the agency’s funding opportunities on this topic. Learn more and submit a grant application today. Don’t delay—the deadline is July 30, 2024. https://lnkd.in/eYjt-z-N cc: Beth Wells Kolaleh Eskandanian, PhD, MBA, PMP The National Institute on Drug Abuse (NIDA) Leonardo M. Angelone Michael Wolfson Youseph Yazdi Julia Finkel Francesca (Dolcimascolo) Joseph, MD, MBA Juliana Perl Children's National Hospital Michael Anderson, MD, MBA Meghan Delaney, DO, MPH John Konsin Ken Nelson Andrey Ostrovsky, MD, FAAP Anna Dunn

Starlight Cardiovascular has been awarded a $2M Phase II SBIR grant from the National Heart, Lung, and Blood Institute to support development of Pulmonary Flow Restrictors. "Not only will this new device help improve the outcomes for babies with Hypoplastic Left Heart Syndrome undergoing a hybrid procedure, but these innovative Pulmonary Flow Restrictors will open up a myriad of other applications to the benefit of children with Congenital Heart Disease." - Dr. Mark Galantowicz, Chief of Cardiothoracic Surgery and Director of The Heart Center at Nationwide Children's Hospital. #medtech #pediatrics #chd #NHLBI #SBIR Learn more at https://lnkd.in/gmDXt68H

Join us online this Thursday 25 April from 1-2 pm PST for a discussion at Stanford Byers Center for Biodesign about Advancing pediatric and maternal health through innovation. We will be hearing from three innovators about their journeys in this space, as well as the challenges they have faced and the resources they have found helpful. This is part of an ongoing series that highlights where innovation can be used to help address health inequities. Anyone is welcome to join via Zoom! #healthequity #womenshealth #pediatricinnovation #healthtechnology Impact1 at Stanford Biodesign Tekano Health Equity in South Africa Marta Arenas-Jal, PhD, Juliana Perl Teja Chintalapati Ifeanyi Nsofor, MD René Van As, Yakira Mishan Honor Magon, MD, James Wall Dr Gabriel S.A. Nel Gareth Obery

👏 👏 👏 We're excited to hear from these inspiring 9 finalists at the Pitch Competition at Tuesday's Innovation Showcase! Join us: https://lnkd.in/gFb7PWZP Aditya Kulkarni - CareNX Innovations Christine Rohan - Vasowatch Eric Heinberg - PARTURA Medical Kathleen Cassidy - Lucie Medical Marta Arenas-Jal, PhD - Inlumos Neil Ray - Raydiant Oximetry, Inc. Phillip M. - FetoPatch Roni Cantor-Balan - Ciconia Medical Sunghoon Kim - Grubbs SonicBalloon