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Swedish medical technology company Neola Medical AB has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for Neola®, its technology designed to provide non-invasive, continuous lung monitoring in preterm born babies. The company develops medical technology aimed at supporting earlier detection of potentially life-threatening lung complications in neonatal intensive care.
The FDA designation applies to Neola®’s intended use in supporting the timely detection of potentially life-threatening lung collapse, including pneumothorax. The regulatory milestone strengthens Neola Medical’s U.S. regulatory pathway and provides the company with additional opportunities for interaction with the FDA as it continues development and clinical preparations for the U.S. market.
Through the FDA’s Breakthrough Devices Program, Neola Medical will have access to more frequent and interactive communication with the regulator during the development process, as well as prioritized review of subsequent regulatory submissions. The program is intended for medical devices that have the potential to provide more effective diagnosis or treatment for life-threatening or irreversibly debilitating conditions.
“This is an important recognition of the potential of Neola® to address a critical unmet need in neonatal intensive care.”
“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. Our objective is to bring Neola® one step closer to the preterm born babies who benefit from earlier detection of life-threatening lung collapse.”
Neola® is being developed to continuously monitor the lungs of preterm born babies without invasive procedures. Its patented technology, developed at Lund University in Sweden, uses near-infrared light measurements in the lungs to detect changes and provide real-time alerts of potentially life-threatening lung collapse.
Pneumothorax is a severe pulmonary complication in which air accumulates between the lung and chest wall, potentially causing the lung to collapse. For vulnerable preterm infants receiving care in neonatal intensive care units, earlier identification of such complications may support timely clinical intervention and decision-making.
The FDA Breakthrough Device Designation reflects Neola Medical’s focus on this clinical use case, where continuous monitoring could provide a potential benefit compared with approaches that rely on intermittent assessment. The company aims for Neola® to support earlier intervention, improve clinical decision-making and contribute to better outcomes for preterm born babies.
Following the designation, Neola Medical will continue its regulatory and clinical preparations in the United States. This includes further discussions with the FDA to establish the evidence needed to support a future market authorization for Neola®.
The Breakthrough Device Designation does not constitute FDA approval, clearance or authorization to market Neola® in the United States. The company will therefore need to complete further clinical and regulatory requirements before the device can become commercially available in the U.S.
From neonatal care and medical devices to digital health, diagnostics and life sciences, MedTech World Europe | Malta 2026 will bring together healthcare leaders, innovators, investors and startups from across the global MedTech community. Taking place in Malta from 11–13 November, the event will provide a platform to explore the technologies and ideas addressing clinical needs across healthcare. Book your ticket to join MedTech World Europe | Malta 2026 and connect with the people driving innovation across the sector.
