Neola uses near-infrared light to continuously and non-invasively monitor lung status in preterm infants, with the aim of flagging pneumothorax, a severe and potentially fatal pulmonary complication, before it becomes critical. The Breakthrough Devices Program gives Neola Medical more frequent, interactive dialogue with the FDA during development, along with prioritized review of future regulatory submissions.

The technology was developed at Lund University based on near-infrared light measurements of the lungs, building on Sweden’s long history of medtech innovation in neonatal care.

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GPX Medical is building on a historic Swedish legacy of medical technology innovation and the company’s mission is to revolutionize the care of infants born preterm. GPX Medical was founded in Lund, Sweden, in 2016 and is developing NEOLA, a lung analyzer for continuous monitoring of the lungs of preterm-born infants using a technology that […]

“Receiving Breakthrough Device Designation from the FDA is a major milestone for Neola Medical and strengthens our U.S. regulatory pathway. It gives us the opportunity for a more direct and prioritized dialogue with the FDA, which may support a more efficient regulatory process and accelerate our route to market,” says Hanna Sjöström, CEO, Neola.