A New Milestone in Electronic Fetal Monitoring: FDA 510(k) Clearance Granted for Dawes-Redman CTG Analysis™

ADDISON, Ill., March 24, 2025 /PRNewswire/ -- Huntleigh Healthcare is proud to announce that the world-renowned Dawes-Redman CTG Analysis™ has been approved for use in the U.S. by the Food and Drug Administration (FDA). This landmark achievement aims to assist clinicians in improving trace interpretation and preventing poor outcomes for babies and families.

The Dawes-Redman CTG Analysis determines whether a non-stress test (NST) trace has met it's 'criteria of normality', derived from a database of well over 100,000 ¹ 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 US 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," commented Gang Zhang, Managing Director of Huntleigh Healthcare.

The Dawes Redman™ algorithm has undergone continual refinement over the last 40 years, and is supported by over 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 ten 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 BeCA^® fetal monitor distributed in the USA by Clinical Computer Systems Incorporated.

A Lifetime's Work

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 ever since.

Gabriel Jones, Director Dawes Redman R&D University of Oxford, shared his reaction: "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. For decades, our team has worked to refine this technology, ensuring it provides clinicians with a reliable, evidence-based tool for assessing fetal wellbeing. 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."

Globally Recognised

Dawes Redman™ has been employed across the globe 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 computerised CTG analysis in future versions.⁴

Todd Blockinger, Business Unit Director for Huntleigh USA, declared: "We are tremendously excited to bring Dawes Redman to the US. 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."

Read more about the Dawes Redman analysis at https://www.huntleigh-healthcare.us/

About Huntleigh Healthcare Ltd

A proud member of the Arjo family, Huntleigh Healthcare are a UK based manufacturer and a leading global provider of innovative and high quality medical equipment for healthcare professionals. With world leading brands such as Sonicaid^®, Dopplex^®, Hydroven^® and Smartsigns^®, Huntleigh offers solutions to meet wide-ranging healthcare requirements in obstetrics, vascular assessment & treatment and patient monitoring.

Huntleigh and the Sonicaid^® brand have been at the forefront of maternity product innovation for over 40 years, developing a world leading 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. 

¹Update from Oxford (as of Nov 24)

²Jones, 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.

CONTACT:

For more information, please contact:
Todd Blockinger, Business Unit Director
Tel: 224-223-2320
Email: [email protected]

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SOURCE Arjo Inc.