The program is supported and partly financed by the American food and Drug Administration FDA, with the aim that more technological innovation designed for children will reach the market and patients.
The company’s medical device, Neola, has been selected as a promising innovation with the potential to improve neonatal intensive care from the first day in the clinic, describes the company. With Neola, continuous lung monitoring of premature babies can detect complications immediately and ensure that the babies receive the care they need more quickly.
Impact1 CEO Summit
In this year’s Stanford Impact1 CEO Summit, an exclusive network of chosen CEOs within leading healthtech companies in pediatrics, which took place October 12-13, 2023, Neola Medical’s CEO Hanna Sjöström participated on site in Palo Alto, Silicon Valley, USA.
“It means a lot to us to be part of the exclusive network of healtech companies partnering with Stanford to rapidly bring innovation that makes a real difference to children’s hospitals in the U.S. and around the world. It is possible for Neola Medical to be a game changer in the care of preterm born babies. Stanford and the FDA are determined to bring more medical technology innovation to the care of children and now when we have full support, I believe it will be of great importance for our upcoming launch of Neola, to hospitals in the U.S.,” says Hanna Sjöström CEO Neola Medical.
The Impact1 program
Stanford launched the Impact1 program with the vision of improving the health, safety and quality of life of pediatric and maternal care patients globally. The name Impact1 comes from the purpose of the program to promote innovations that provide precisely “impact from day 1”. The goal of the program is to meet the children’s unique needs of hospital care, by accelerating the development and increasing the availability of effective new technology in healthcare that has been developed specifically for children.
In the Impact1 program, Neola Medical gets access to company development in Stanford’s proven innovation process, a broad expertise with experts from Stanford and Silicon Valley in development for, among other things, medical technology products, regulatory experts, commercialization, and close collaboration with leading doctors in neonatal intensive care.
Each year, the US Food and Drug Administration (FDA) approves far fewer medical devices for use in children than in adults. This means that pediatricians do not always have access to the advanced medical technology they need to meet the unique care needs of their small, vulnerable patients. The FDA is supporting Stanford’s Impact1 program by awarding five years of funding to the Stanford Pediatric Device Consortium (PDC) in 2023, with the aim of supporting advanced technological innovation to reach the vulnerable pediatric patient group as quickly as possible. The selected companies also receive a special forum with FDA pediatricians and regulatory experts for informal discussion of the companies’ regulatory strategy and study plan.
Photo of Hanna Sjöström: Roger Nellsjö