New technology aims to standardize and modernize maternity care

FDA approves new fetal monitor: ©Faustasyan - stock.adobe.com

Huntleigh Healthcare announced that its Dawes-Redman CTG Analysis has received approval from the U.S. Food and Drug Administration, boosting fetal monitoring technology. This milestone is expected to aid clinicians in improving trace interpretation and reducing adverse outcomes for newborns and families.

The Dawes-Redman CTG Analysis determines whether a non-stress test trace meets established criteria of normality, derived from a database of over 100,000 recorded traces and their outcomes. The technology evaluates critical factors, including basal heart rate, sinusoidal rhythms, and short-term variation of the fetal heart rate—the latter being impossible to calculate manually. By providing an objective assessment, the system aims to standardize and modernize maternity care.

"Introducing the Dawes-Redman analysis to the U.S. marks a significant milestone, leading the way for a standardized and modernized maternity care approach," said Gang Zhang, managing director of Huntleigh Healthcare. "This objective assessment empowers clinicians to uncover the invisible insights, offering reassurance and clarity during critical moments."

The technology has been continually refined over the past 40 years and is supported by more than 125 peer-reviewed studies published internationally. The system boasts a high specificity rate in identifying fetal well-being, further cementing its credibility within the medical community. Recent developments by a team at the University of Oxford have enhanced the system’s efficiency, allowing a healthy trace to be analyzed in as little as ten minutes, compared to the 30 minutes or more traditionally required by clinicians.

"The entire team is delighted to see the Dawes-Redman algorithm gain FDA 510(k) clearance, marking a significant step towards improving antenatal care in the U.S.," said Gabriel Jones, director of Dawes-Redman R&D at the University of Oxford. "For decades, our team has worked to refine this technology, ensuring it provides clinicians with a reliable, evidence-based tool for assessing fetal well-being."

The Dawes-Redman CTG Analysis will be available exclusively in Huntleigh’s Sonicaid TEAM3 series of fetal monitors and the OBIX BeCA fetal monitor, which is distributed in the U.S. by Clinical Computer Systems Inc.

The system has already been widely adopted globally and was specifically recommended in the second version of NHS England's 'Saving Babies Lives' care bundle.

"We are tremendously excited to bring Dawes-Redman to the U.S.," said Todd Blockinger, business unit director for Huntleigh USA. "We've been quite envious of our colleagues across the globe being able to offer this life-saving technology to their clinical stakeholders, so we can't wait to bring these benefits to the American maternal care communities."

With FDA approval now secured, Huntleigh Healthcare anticipates that the Dawes-Redman CTG Analysis will play a key role in improving maternity care across the United States, providing clinicians with an advanced, data-driven approach to fetal monitoring.