Neola Medical wins FDA Breakthrough Device designation for preterm infant lung monitor

• Neola Medical won FDA Breakthrough Device Designation for Neola, a non-invasive device for continuous lung monitoring in preterm babies.
• Designation targets earlier detection of potentially life-threatening lung collapse, strengthening the U.S. regulatory pathway.
• Status provides more frequent FDA interaction, prioritized review of future submissions; it is not market clearance or approval.

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