Dawes-Redman CTG Analysis™ receives 510(k) approval from the FDA
Dawes-Redman CTG Analysis™, used for fetal diagnostics, has received 510(k) approval from the U.S. Food and Drug Administration (FDA). Arjo's diagnostics division, Huntleigh Healthcare, has been the exclusive global distributor of the solution for many years, and the approval means it can now be offered to customers also in the US market.
The analysis evaluates factors such as basal heart rate, sinusoidal rhythms, and the short-term variation of the fetal heart rate, a factor that is impossible to calculate manually.
“Being able to offer the Dawes Redman analysis to customers in the USA is a significant milestone that enables the expansion of this standardized and modern method for maternity care. Through this objective assessment, we make it possible to uncover what is not visible to the naked eye, providing both reassurance and clarity during critical moments,” says Gang Zhang, head of Arjo's diagnostics division, Huntleigh Healthcare.
The algorithms underlying the analysis were originally developed by Professors Geoffrey Dawes and Chris Redman at Oxford University and are now supported by over 125 internationally published scientific articles1. Huntleigh Healthcare has held exclusive distribution rights to the solution through the Sonicaid product since it first became available on the market.
- Jones, Gabriel Davis, et al. "Computerized analysis of antepartum cardiotocography: a review." Maternal-Fetal Medicine 4.2 (2022): 130-140.
For more information, please contact:
Maria Nilsson, EVP Communication & Public Relations
Phone: +46 734 244 515
Email: maria.nilsson@arjo.com
About Arjo
At Arjo, we believe that empowering movement within healthcare environments is essential to quality care. Our products and solutions are designed to promote a safe and dignified experience through patient handling, medical beds, personal hygiene, disinfection, diagnostics, and the prevention of pressure injuries and venous thromboembolism. With more than 6,500 people worldwide and over 65 years caring for patients and healthcare professionals, we are committed to driving healthier outcomes for people facing mobility challenges. www.arjo.com