New Award Accelerates Development and Provides Regulatory Guidance for Lightengale®
ATLANTA, GEORGIA, USA, February 8, 2022 /EINPresswire.com/ — Lightengale®, an innovator in intravenous tubing (IVT) systems, announced that it won a grant through the FDA Pediatric Device Consortium. The award is managed by the Consortium for Technology and Innovation in Pediatrics (CTIP), a med tech accelerator at Children’s Hospital of Los Angeles (CHLA) and the University of Southern California (USC). Awarded in 2019, the program’s support includes direct and indirect financial support in addition to guidance on issues ranging from intellectual property, prototyping, engineering, testing, and clinical trial design.
The Lightengale illuminated IVT system was developed to reduce the nursing burden and risks associated with tracing intravenous tubing (IVT) in the ICU, leading to improved patient outcomes. By engaging clinicians, engineers, regulators, and hospital administrators in the technology development process, CTIP will help drive progression from the initial prototype through product validation and simulated ICU studies. In addition, as a CTIP portfolio company, Lightengale is supported by advocates within the FDA to help navigate regulatory hurdles and ensure it is on the right path for FDA submission.
“Since first being introduced to CTIP in 2019, the organization has provided Lightengale with subject matter expertise, access to key medical professionals at CHLA, UCLA and Cedar’s Sinai, and additional grant writing support. CTIP has been critical in helping shape the development of the Lightengale system.”
Hans Utz, Founder and CEO
About the Consortium for Technology and Innovation in Pediatrics (CTIP) Program
The Consortium for Technology and Innovation in Pediatrics (CTIP) Program is a pediatric medical device accelerator based at Children’s Hospital Los Angeles (CHLA) and the University of Southern California (USC). Established in 2011 and first funded by the U.S. Food and Drug Administration in 2013, CTIP promotes the commercialization and clinical use of pediatric medical device technology. In August 2018, CTIP was awarded a new $6.6 million P50 grant from the FDA to continue research and development of MedTech for children (Grant Number IP50FD006425-01,PI: Espinonza).
Lightengale is an Atlanta-based medical device company on a mission to reduce IVT mix-ups in ICUs, increasing nursing efficiency, reducing errors – and saving lives. Founded in 2016 by innovator and entrepreneur Hans Utz, the Company emerged in response to Mr. Utz’s experience in observing ICU nurses caring for his infant son. As he watched nurses manually trace lines, he was alarmed, conscientious of the complexity, time involved and potential risks. As a trained engineer, he recognized a practical solution: if nurses could easily see and distinguish an infusion line from pump to patient, the whole process to identify IVT would be faster and safer. Patient safety demands better solutions. Lightengale is illuminating the way. For more information visit lightengalehealth.com.