Neola Medical AB has received Breakthrough Device Designation from the US Food and Drug Administration (FDA) for Neola®, a non-invasive technology designed for continuous lung monitoring in babies born prematurely.
The device is being developed to support earlier detection of potentially life-threatening lung collapse, including pneumothorax, in premature infants receiving neonatal intensive care.
The designation provides Neola Medical with opportunities for more frequent and interactive communication with the FDA during the device development process.
It also allows for priority review of eligible regulatory submissions, supporting the company’s ongoing US regulatory strategy.
Neola® is intended to continuously monitor changes in the lungs without requiring an invasive procedure.
The technology could provide clinical teams with additional information to help identify serious pulmonary complications at an early stage and support timely intervention.
Following the designation, Neola Medical will continue its clinical and regulatory preparations in the United States.
This includes further discussions with the FDA regarding the evidence and regulatory requirements needed for future market authorisation.
Pneumothorax is a serious complication that can affect premature babies and requires rapid diagnosis and treatment.
The Breakthrough Device Designation does not represent FDA approval, clearance or market authorisation for Neola®.
