FDA grants Breakthrough Device Designation to Neola for continuous lung monitoring
Key Insights
Neola Medical AB (search) received FDA Breakthrough Device Designation for Neola (search), a non-invasive device for continuous lung monitoring in preterm born babies.
The designation covers the intended use of detecting potentially life-threatening lung collapse, including pneumothorax (search), in neonatal intensive care.
The program provides more frequent FDA interaction and prioritized review of subsequent submissions, but does not constitute approval, clearance or marketing authorization.
Swedish medical technology company Neola Medical AB (search) has received Breakthrough Device Designation from the U.S. Food and Drug Administration (search) for Neola (search), its technology for non-invasive, continuous lung monitoring in preterm born babies. The designation applies to the device's intended use in supporting timely detection of potentially life-threatening lung collapse, including pneumothorax (search), a complication in which air accumulates between the lung and chest wall and can cause the lung to collapse.
Neola (search) uses patented near-infrared light measurements in the lungs to detect changes and provide real-time alerts, and was developed at Lund University in Sweden. The company says continuous monitoring could offer a potential benefit over approaches that rely on intermittent assessment in neonatal intensive care units, where earlier identification of complications may support timely clinical intervention and decision-making.
Under the FDA's Breakthrough Devices Program, which is intended for devices with the potential to provide more effective diagnosis or treatment of life-threatening or irreversibly debilitating conditions, Neola (search) Medical gains more frequent and interactive communication with the regulator and prioritized review of subsequent submissions. The company will continue regulatory and clinical preparations in the United States, including discussions with the FDA on the evidence needed for a future market authorization. The designation does not constitute FDA approval, clearance or authorization to market Neola in the United States.