The US Food and Drug Administration (FDA) has granted 510(k) approval for UK-based Huntleigh Healthcare’s Dawes-Redman cardiotocography (CTG) Analysis intended for use in foetal monitoring.
This approval marks a step forward in aiding clinicians in enhancing the interpretation of traces and preventing adverse outcomes for newborns and their families.
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The Dawes-Redman CTG Analysis is designed to assess if a non-stress test (NST) trace meets the “criteria of normality”.
These criteria are based on a substantial database comprising more than 100,000 traces and corresponding outcomes.
Dawes-Redman CTG Analysis examines various factors, including sinusoidal rhythms, basal heart rate, and the short-term variation (STV) of the foetal heart rate, which is notably challenging for a manual calculation.
Huntleigh Healthcare managing director Gang Zhang said: “Introducing the Dawes Redman analysis to the US marks a significant milestone, leading the way for a standardised and modernised maternity care approach.
“This objective assessment empowers clinicians to uncover the invisible insights, offering reassurance and clarity during critical moments.”
With more than four decades of continuous refinement, the Dawes-Redman algorithm is backed by more than 125 peer-reviewed articles, which are published globally.
Huntleigh Healthcare noted that the algorithm’s effectiveness in detecting foetal well-being is supported by its high specificity.
The University of Oxford team has advanced the analysis, enabling a healthy trace to be examined in approximately ten minutes when compared to the 30 minutes or more needed by a clinician.
Available exclusively through the company’s Sonicaid TEAM3 series of foetal monitors and the OBIX BeCA foetal monitor by Clinical Computer Systems distributed in the US, the Dawes-Redman CTG Analysis represents a culmination of years of development following the original algorithm’s creation by the Oxford University professors Chris Redman and Geoffrey Dawes.
The company’s Sonicaid brand has maintained exclusive distribution rights for the analysis since its initial commercial availability.
The Dawes Redman CTG Analysis has been utilised globally to enhance the interpretation of NST and support clinicians in making crucial decisions.
It was specifically recommended in the second version of the National Health Service (NHS) England’s “Saving Babies Lives” care bundle.
