LONDON and ROCHESTER, Minn., May 20, 2025 — UK-based medical technology firm SIME Diagnostics has announced the completion of a U.S. clinical trial for its AI-driven Lung Maturity Test (LMT) designed for newborns born late-preterm. The Mayo Clinic’s Rochester Neonatal team presented the study’s conclusions at the Pediatric Academic Societies (PAS) 2025 Conference in Honolulu on April 27th.
Addressing an Unmet Need in the NICU
According to national health statistics, approximately 300,000 infants in the United States are born between 32 and 36 weeks of gestation annually.[1] These infants are at a greater risk of respiratory distress, a major contributor to neonatal morbidity and prolonged hospital stays. Current clinical practice often involves a “wait and see” approach to determine which infants require intervention. This can lead to increased NICU admissions, delayed treatment, higher healthcare expenses, and added stress for families and newborns. The AI-based LMT seeks to fill this void by offering an objective screening tool to help identify newborns at risk in a timely manner.
Advancing Neonatal Respiratory Diagnostics with AI
To tackle this clinical issue, a study was carried out at the Mayo Clinic in Rochester, involving 207 late-preterm infants (over 30 weeks gestation).[2] Gastric aspirate samples were examined using a point-of-care device created by SIME Diagnostics. The results indicated that the Lung Maturity Test (LMT) could evaluate biomarkers linked to lung maturity and facilitate the early detection of infants at risk of respiratory distress. The study determined that this point-of-care device accurately predicted the need for extended respiratory support and effectively identified patients whose respiratory support needs would resolve within 6 hours.
Rapid Lung Maturity Test (LMT) Powered by AI and Photonics
This innovative platform features a point-of-care device and a single-use cartridge that quickly analyzes routinely collected samples without needing reagents. The device provides real-time analysis of lung biochemistry by measuring key biomarkers—lecithin and sphingomyelin. The ratio of these biomarkers indicates surfactant levels, which are crucial for efficient oxygen exchange in developing lungs.
Supporting Timely, Targeted Respiratory Care for Newborns
By giving clinicians data to inform respiratory support decisions within the first hour of life, the AI platform can facilitate early intervention for at-risk infants and reduce unnecessary treatments. Specifically designed for intensive care environments, this platform helps healthcare professionals deliver targeted respiratory care promptly. Ongoing research and clinical evaluations will aim to refine its application and explore its potential use across various hospital settings.
About SIME Diagnostics
SIME Diagnostics develops AI-driven medical diagnostics platforms for acute and intensive care settings. The company’s technology uses machine learning and specialized hardware for rapid, point-of-care testing for respiratory diseases. The Lung Maturity Test (LMT), the company’s initial product, is currently under FDA review, and additional solutions for adult respiratory diagnostics are being developed. More information about the company is available at and on SIME Diagnostics’ social media.
Conflict of Interest Statement
Mayo Clinic holds a financial stake in the technology mentioned in this press release. Any revenue Mayo Clinic receives will be used to support its non-profit mission in patient care, education, and research.
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SOURCE SIME Diagnostics
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