SIME Diagnostics Announces Results of Clinical Study on AI-Powered Lung Maturity Test in U.S. Neonatal Intensive Care Unit

LONDON  and ROCHESTER, Minn., May 20, 2025 /PRNewswire/ -- SIME Diagnostics, a UK-based medical technology company today announced the completion of a clinical study evaluating an AI-powered Lung Maturity Test (LMT) for late-preterm newborns in a U.S. patient population. The findings were presented by Mayo Clinic's Rochester Neonatal team at the Pediatric Academic Societies (PAS) 2025 Conference in Honolulu on the 27^th of April.  

Addressing an Unmet Need in the NICU  
Each year, an estimated 300,000 babies in the United States are born between 32 and 36 weeks' gestation, according to national health statistics.^[1] This population often faces a higher risk of respiratory distress, which is a leading cause of neonatal morbidity and extended hospital stays. Traditional clinical practice often requires a "wait and see" approach to identify which infants may need intervention. This practice can contribute to higher rates of NICU admissions, delayed treatment, increased healthcare costs, and additional pressure on families and infants. The AI-based LMT aims to address this gap by providing an objective screening test to assist in the timely identification of at-risk newborns. 

Advancing Neonatal Respiratory Diagnostics with AI  
To address this clinical challenge, a study was conducted at Mayo Clinic in Rochester enrolling 207 late-preterm infants (>30 weeks' gestation).^[2] Samples of gastric aspirate were analyzed using a point-of-care device developed by SIME Diagnostics. Results showed that the Lung Maturity Test (LMT) was able to assess biomarkers associated with lung maturity, and support early identification of infants at risk for respiratory distress. The study concluded that this point-of-care device accurately predicted the need for prolonged respiratory support and was effective at identifying patients whose need for respiratory support would resolve within 6 hours.  

Rapid Lung Maturity Test (LMT) Powered by AI and Photonics  
This first-of-its-kind platform consists of a point-of-care device and single-use cartridge that rapidly analyzes routinely collected samples without the need for reagents. The device enables real-time analysis of lung biochemistry by measuring key biomarkers—lecithin and sphingomyelin. The ratio of these biomarkers reflects surfactant levels, which are essential for effective oxygen exchange in developing lungs.  

Supporting Timely, Targeted Respiratory Care for Newborns 
By providing clinicians with data to guide respiratory support decisions within the first hour of life, the AI platform can help ensure early intervention for at-risk infants and minimize unnecessary treatments and interventions. Specifically designed for intensive care settings, this platform assists healthcare professionals in delivering targeted respiratory care within the first hour of life. Ongoing research and clinical evaluation will seek to refine its application and inform its potential use across various hospital environments. 

About SIME Diagnostics  
SIME Diagnostics develops AI-powered medical diagnostics platforms designed for use in acute and intensive care settings. The company's technology leverages machine learning and proprietary hardware to enable rapid, point-of-care testing for respiratory diseases. The Lung Maturity Test (LMT), the company's first product, is currently under FDA review, with additional solutions for adult respiratory diagnostics in development. More information on the company can be found by visiting http://www.simedx.com or following SIME Diagnostics on LinkedIn. 

Conflict of Interest Statement  
Mayo Clinic has a financial interest in the technology referenced in this press release. Mayo Clinic will use any revenue it receives to support its not-for-profit mission in patient care, education, and research.  

Citations  
¹ https://www.cdc.gov/nchs/products/databriefs/db24.htm 
² https://cdmcd.co/LE44aR 

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SOURCE SIME Diagnostics