12:57 AM EDT, 09/07/2026 (MT Newswires) -- Neola Medical's (NEOLA.ST) eponymous medical device for non-invasive, continuous lung monitoring in preterm-born babies received the breakthrough device status from the US Food and Drug Administration. The designation paves the way for prioritized review of regulatory submissions for the Neola device, the Swedish medical technology company said Sept. 4.

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