We are on a journey to revolutionize neonatal intensive care

Every day, one in ten babies are born preterm, many of them with underdeveloped lungs that can advance to life-threatening conditions during their stay in the hospital and risk disabilities later on in life. They deserve a better start in life and health care professionals need support of modern technology to make life-changing decisions that can improve the health of these fragile patients.

Neola Medical’s groundbreaking innovation Neola® aims to upgrade today’s neonatal intensive care to include continuous lung monitoring and possibility of instant detection of life-threatening complications.

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Presentation of Neola

CEO of Neola Medical, Hanna Sjöström, presents Neola, a medical device for continuous monitoring of the lungs.

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Lung monitoring with Neola

Neola Medicals’ proven technology uses laser spectroscopy to continuously measure lung volume changes and oxygen gas concentration in the lungs of preterm born infants. This is a safe and non-invasive method to monitor the lungs of these vulnerable patients in real time, providing the possibility of instant detection and treatment of complications and thus improving the care and decreasing the risk of disabilities later in life.

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Certified according to ISO 13485

Neola Medical has undergone an extensive review process of its quality management system with an approved result, which means that the company is certified according to ISO 13485. The certification shows that the company has a well-reviewed and comprehensive quality management system for the development, sale, and fulfillment of regulatory market requirements of medical technology equipment.

IECEE CB certificate by FORCE Technology

Neola Medical’s medical device for continuous monitoring of the lungs of preterm born infants, Neola®, has obtained a CB certificate, signifying that the product has undergone a rigorous and comprehensive testing and evaluation process at an accredited and independent IECEE testing house, FORCE Technology. The CB certification for IEC 60601-1 and IEC 60601-1-2 indicates that the product meets specific quality requirements and international standards for medical devices in healthcare, with particularly high demands on safety, essential performance, and electromagnetic compatibility. The CB certificate is internationally recognized in about 50 countries and will form the basis for meeting the regulatory market requirements.

Selected as a Stanford Impact1 company

Neola®, has been recognised by leading experts in neonatology at Stanford University as a promising innovation with the potential to upgrade neonatal intensive care from the first day in the clinic. As a result, Neola Medical is one of the few companies that have been selected as a Stanford Impact1 company to receive support from the Stanford University Impact1 program. The program is supported and partly financed by the US Food and Drug Administration (FDA), with the aim of supporting advanced technological innovation designed for children to reach the market and the vulnerable pediatric patient group as quickly as possible.

Latest News from Neola Medical

2024-11-06 07:00
Neola Medical Q3 Report 2024 – Intensifying preparations for the first pivotal clinical study on preterm born babies in the U.S. to secure market approval by the FDA

2024-10-30 07:00
Neola Medical invites to presentation of the Q3-report 2024

2024-10-01 07:00
Neola Medical’s CEO highlights recent steps toward market approval in the Autumn 2024 Investor Letter

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For Investors

We are on a journey to revolutionize neonatal intensive care
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