Unlocking medical breakthroughs for kids.

Scientist in a white laboratory coat working, seen through a softly blurred foreground

American taxpayers spend $200B/year on research and development.

Source: LES Nouvelles

Yet less than

of federally funded inventions ever reach the market.

Source: LES Nouvelles

Pediatric medical device development is

a decade behind.

Recent FDA approvals — PMA and HDE devices, annual counts FDA device PMA and HDE applications approved with and without pediatric indications, by fiscal year. 2015: 52 without and 14 with pediatric indications; 2016: 59 without and 14 with pediatric indications; 2017: 49 without and 19 with pediatric indications; 2018: 37 without and 22 with pediatric indications; 2019: 46 without and 10 with pediatric indications; 2020: 37 without and 26 with pediatric indications; 2021: 44 without and 15 with pediatric indications; 2022: 31 without and 20 with pediatric indications; 2023: 28 without and 31 with pediatric indications; 2024: 37 without and 19 with pediatric indications. 0 20 40 60 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 Recent FDA approvals — PMA and HDE devices, two-year totals FDA device PMA and HDE applications approved with and without pediatric indications, grouped into two-fiscal-year totals. 2015–2016: 111 without and 28 with pediatric indications; 2017–2018: 86 without and 41 with pediatric indications; 2019–2020: 83 without and 36 with pediatric indications; 2021–2022: 75 without and 35 with pediatric indications; 2023–2024: 65 without and 50 with pediatric indications. 0 40 80 120 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
Adult Pediatric

Sources: FDA, The Lancet

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