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Neola Medical Q2 Report 2025 – First U.S. Clinical Study Site Agreement Signed, Key Step in Regulatory Path to Market Authorization

Aug 25, 2025

Neola Medical advanced its U.S. regulatory pathway in the second quarter of 2025, signing an agreement with Children’s Regional Hospital at Cooper and securing IRB approval to enable the initiation of the pivotal clinical study on preterm born babies in the U.S....

Neola Medical Q2 Report 2024 – Key milestones meet partial regulatory requirements for FDA approval

Aug 15, 2024

Neola Medical reached several critical milestones aligned with its business strategy, aimed at market approval by the FDA. The Human Factors Validation Study with Neola®, was successfully concluded with neonatal nurses in the USA, and will lay a foundation for the...

Neola Medical Q2 rapport 2023 – Ökad takt i det marknadsförberedande arbetet inför lansering i USA

Aug 15, 2023

Under kvartalet har bolaget arbetat intensivt i produktutvecklingen med tekniska verifieringsstudier, regulatoriskt arbete och möte med amerikanska läkemedelsverket. Bolaget har deltagit vid största konferensen för neonatologi i USA samt...
Neola Medical Q2 rapport 2022- ett kvartal med stora kommersiella framsteg

Neola Medical Q2 rapport 2022- ett kvartal med stora kommersiella framsteg

Aug 16, 2022

Pressmeddelande Lund, Sverige, 16 augusti 2022, kl. 08.30 CET Viktiga steg mot regulatoriskt godkännande och kommersialisering har tagits under kvartalet. Positiva resultat från stor klinisk studie på nyfödda barn, förvärv av...

Neola Medical AB: Neola Medical Q2 rapport 2022- ett kvartal med stora kommersiella framsteg

Aug 16, 2022

PressmeddelandeLund, Sverige, 16 augusti 2022, kl. 08.30 CETViktiga steg mot regulatoriskt godkännande och kommersialisering har tagits under kvartalet. Positiva resultat från stor klinisk studie på nyfödda barn, förvärv av strategiska IP-rättigheter och förstärkt...
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Neola Medical AB (publ), founded in 2016 in Lund, Sweden, aims to advance neonatal intensive care with Neola®—a medical device designed for continuous lung monitoring and real-time alerts of potentially life-threatening complications.

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Neola Medical AB
Ideon Gateway
Scheelevägen 27
223 63 Lund
info@neolamedical.com

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Neola Medical, Inc.
Nordic Innovation House
470 Ramona Street PMB
Palo Alto CA 94301-1707
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