Huntleigh Healthcare has won U.S. Food and Drug Administration (FDA) 510(k) clearance for its renowned Dawes-Redman CTG Analysis, which aims to help clinicians improve trace interpretation and prevent poor outcomes for babies and families.

The Dawes-Redman CTG Analysis determines whether a non-stress test (NST) trace has met its “criteria of normality,” derived from a database of well over 100,000¹ traces and their outcomes. The analysis evaluates factors such as basal heart rate, sinusoidal rhythms, and the short-term variation (STV) of the fetal heart rate, a factor impossible to calculate manually. 

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

The Dawes Redman algorithm has undergone continual refinement over the last 40 years, and is supported by more than 125 peer-reviewed articles, published internationally.² The analysis is proven to be effective at identifying fetal wellbeing, as evidenced by its high specificity.³

The University of Oxford team has further developed the analysis, allowing a healthy trace to be analyzed in as little as 10 minutes, compared to the 30 minutes or more that a clinician might require. The Dawes-Redman CTG Analysis is exclusively available in Huntleigh’s Sonicaid TEAM3 series of fetal monitors, and the OBIX BeCAfetal monitor distributed in the United States by Clinical Computer Systems Incorporated. 

Decades of development have followed the creation of the original algorithm by Professors Geoffrey Dawes and Chris Redman at Oxford University. Exclusive distribution rights for the Dawes-Redman CTG Analysis have been held by Huntleigh’s Sonicaid brand since it first became commercially available and have been held by the company since then. 

“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.,” stated Gabriel Jones, director, Dawes Redman R&D, 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. This milestone reflects the dedication of researchers and clinicians committed to advancing maternity care through innovation. We look forward to seeing the benefits of Dawes-Redman CTG analysis extend to even more patients worldwide.”

Dawes Redman has been employed worldwide to improve NST interpretation and ultimately help clinicians make life-saving decisions. It was recommended by name in the second version of NHS England’s “Saving Babies Lives” care bundle, cementing the place of computerized CTG analysis in future versions.⁴

“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.” 

A member of the Arjo family, Huntleigh Healthcare is a U.K.-based manufacturer and global provider of medical equipment for healthcare professionals. With brands such as Sonicaid, Dopplex, Hydroven, and Smartsigns, Huntleigh offers solutions to meet wide-ranging healthcare requirements in obstetrics, vascular assessment, and treatment and patient monitoring. 

Huntleigh and the Sonicaid brand have been at the forefront of maternity product innovation for more than 40 years, developing a range of fetal dopplers and monitors. Complementing this range is a suite of software systems addressing every type of maternity environment, from simple single user platforms through to fully integrated installations. 

References
¹ Update from Oxford (as of Nov 24)
² Jones, Gabriel Davis, et al. “Computerized analysis of antepartum cardiotocography: a review.” Maternal-Fetal Medicine 4.2 (2022): 130-140.
³ Davis Jones, G., et al. (2025), Performance evaluation of computerized antepartum fetal heart rate monitoring: Dawes–Redman algorithm at term. Ultrasound Obstet Gynecol, 65: 191-197. 
⁴ “Saving Babies’ Lives Care Bundle Version 2,” Published by NHS England, March 2019.