News

SIME Diagnostics Unveils Promising AI Test for Preterm Infant Lung Maturity

• By John K. Waters
• 06/02/2025

SIME Diagnostics, a UK-based medical technology firm, has completed a clinical study evaluating an artificial intelligence-powered Lung Maturity Test (LMT) designed to identify respiratory risks in late-preterm newborns in the United States. The findings were presented on April 27 by the Mayo Clinic’s Rochester Neonatal team at the Pediatric Academic Societies (PAS) 2025 Conference in Honolulu.

Founded in the UK, SIME Diagnostics develops AI-enabled diagnostic platforms for use in acute and critical care. Its flagship Lung Maturity Test is the first of several planned respiratory-focused solutions.

The test, which analyzes lung biochemistry through a point-of-care device, aims to improve early detection of respiratory distress in infants born between 32 and 36 weeks’ gestation—an estimated 300,000 births annually in the U.S., according to national health statistics^[1].

Clinical Study Results

The Mayo Clinic study enrolled 207 late-preterm infants, all born after 30 weeks of gestation^[2]. Gastric aspirate samples were collected at birth and analyzed using SIME’s proprietary device. According to the research team, the LMT was able to assess biomarkers associated with lung maturity and accurately predict which newborns would require extended respiratory support.

Study investigators noted that the device could also identify patients whose respiratory needs would resolve within six hours, potentially reducing unnecessary interventions and prolonged neonatal intensive care unit (NICU) admissions.

Technology Overview

The LMT platform comprises a point-of-care analyzer and a single-use cartridge. It uses photonics and AI to rapidly measure lecithin and sphingomyelin biomarkers—key indicators of surfactant levels that support oxygen exchange in the lungs—without the need for reagents.

SIME Diagnostics said the device delivers results within the first hour of life, enabling clinicians to make more informed decisions regarding respiratory care. The system is specifically designed for use in intensive care environments.

Potential Healthcare Impact

The LMT could help address a longstanding gap in neonatal care, where a “wait and see” approach is often used to determine whether preterm infants will develop respiratory complications. This can lead to overtreatment or delayed intervention, contributing to higher healthcare costs and stress for families.

SIME Diagnostics stated that further research and ongoing evaluation will continue to inform the device’s application across different clinical settings. The LMT is currently under review by the U.S. Food and Drug Administration.