FDA grants Breakthrough Device Designation to Neola® for continuous lung monitoring

Neola Medical AB has received Breakthrough Device Designation from the US FDA for Neola®, a non-invasive continuous lung monitoring technology designed for preterm babies to detect life-threatening lung collapse. This designation offers prioritized FDA interaction and review, potentially accelerating Neola's US market entry after further clinical and regulatory steps.

This Wire brief sits within Fusion42's coverage of Medtech.