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Levl, an early-stage digital health venture, announced its participation in the Public-Private Partnership for Pediatric Medical Devices (PMD-PPP). This important program is a collaborative effort led by the US National Institutes of Health (NIH) and the Food and Drug Administration (FDA). The partnership includes leading medical device companies such as Johnson & Johnson, Philips, and Medtronic, as well as renowned children's hospitals like Children's National Hospital, Children's Hospital of Orange County (CHOC), and Lurie Children's Hospital of Chicago.

BROOKLYN, N.Y., Aug. 22, 2024 /PRNewswire-PRWeb/ -- Levl, a digital health startup, joins the Public-Private Partnership for Pediatric Medical Devices (PMD-PPP) alongside leaders like Johnson & Johnson, Philips, and top US children's hospitals. Led by the US National Institutes of Health (NIH) and the Food and Drug Administration (FDA), this partnership aims to accelerate pediatric medical device innovation. As the sole startup in this initiative, Levl brings cutting-edge expertise and a startup perspective to support the development of safe, effective, and age-appropriate medical devices for children. This collaboration underscores Levl's commitment to improving pediatric healthcare outcomes through advanced technology and strategic partnerships.

Addressing a Critical Need in Children's Healthcare
Children have unique healthcare needs, but the development of medical devices specifically designed for them lags behind those for adults. This can lead to children being treated with adult devices that are not ideally suited for their smaller bodies or specific medical conditions. The PMD-PPP aims to close this gap by fostering a national network dedicated to pediatric medical device innovation.

Collaboration with Government, Industry Leaders, and Children's Hospitals
The program brings together a diverse group of experts from government, industry, and clinical care to tackle the complex challenges of pediatric medical device development. By combining the resources and expertise of these key stakeholders, the PMD-PPP aims to accelerate the creation of safe, effective, and age-appropriate devices for children.

Levl's Role and Commitment
As the sole startup in this partnership, Levl brings a fresh and innovative perspective to the PMD-PPP. Levl's expertise in developing digital health technologies will contribute significantly to advancing pediatric medical device R&D and commercialization. "Collaborating with the FDA, NIH, and leading children's hospitals ensures this initiative addresses the real-world challenges innovators face in bringing medical devices to youth who need them." said Artin Perse, Co-Founder & CEO of Levl. "We are honored to collaborate with such esteemed partners and contribute to improving pediatric health outcomes."

Program Goals
From 2023-2025, the PMD-PPP will develop a comprehensive plan to support the pediatric medical device ecosystem. This includes establishing clear pathways for funding, regulatory approval, and commercialization of new devices. The ultimate goal is to ensure that children have access to safe, effective, and age-appropriate medical devices.

Public-Sector Partners

• U.S. Food and Drug Administration (FDA)
• U.S. National Institutes of Health (NIH)
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• National Institute of Biomedical Imaging and Bioengineering (NIBIB)
• Biomedical Advanced Research and Development Authority (BARDA)

Private-Sector Partners

- AdvaMed 
- American Academy of Pediatrics 
- Berlin Heart 
- Children's National Hospital 
- Children's Hospital of Orange County (CHOC) 
- CobiCure 
- Charles H. Hood Foundation 
- Johnson & Johnson 
- Lurie Children's Hospital of Chicago 
- MedStar Research Institute 
- OrthoPediatrics 
- Philips 
- Texas A&M 
- Veeva MedTech 
- Levl

About Levl
Levl is an early-stage digital health venture developing a Remote Therapeutic Monitoring (RTM) platform to support clinicians and adolescents in optimizing mental health medication treatments.

For More Information 
For more information about the PMD-PPP and Levl's involvement, please contact:

FNIH Contact:

• Stacey Adam, Ph.D., Vice President, Science Partnerships, [email protected]
• Juan Esparza-Trujillo, M.S., GLPCP, GMPCP, Senior Project Manager, Science Partnerships, Translational Science, [email protected]
• Aimee Ahmed, Director, Strategic Alliances and Advancement, [email protected]

Levl Contact:
Nathan Dubois, Head of Marketing, [email protected], 347-770-2447, findlevl.com

SOURCE Levl