GYNECOLOGY
quantusPREMATURITY uses Artificial Intelligence to analyze a cervical image to help you detect the risk of spontaneous preterm birth early.
Early detection of preterm birth using AI
DESCRIPTION
quantusPREMATURITY is a test for the early detection of spontaneous preterm birth based on the analysis of a cervical image obtained by ultrasound
quantusPrematurity is a software medical device (MDSW) designed for use by gynecologists and obstetricians to provide a prediction (expressed as a risk percentage) of spontaneous preterm birth. The device provides medical information to support decision-making in the management of pregnancies at risk of preterm birth.
The report generated by the device is designed to be used as a diagnostic support tool; its results should not replace a complete clinical evaluation performed by a specialist physician.
USE CASES
CU-PREMATURITY-01: Screening and Risk Stratification for Preterm Birth
In obstetric consultations, quantusPrematurity allows non-invasive estimation of the risk of preterm birth through the analysis of ultrasound images, providing additional information that can help the specialist identify higher-risk pregnant women. This allows for personalized follow-up and, if necessary, early preventive measures.
CU-PREMATURITY-02: Support for Decision-Making in High-Risk Pregnant Women
In pregnant women with risk factors for preterm birth, quantusPrematurity provides an objective and complementary estimate of actual risk, helping the specialist integrate this information with the medical history and other obstetric parameters. This facilitates decision-making and optimizes the management of high-risk pregnant women, especially when the available clinical and ultrasound parameters do not offer a clear estimate of individual risk.
CU-PREMATURITY-03: Support in obstetric emergency units for threatened preterm labor
In pregnant women presenting with symptoms of threatened preterm labor, quantusPrematurity analyzes the cervical image obtained during the emergency examination and provides a risk estimate that, together with the clinical picture, helps decide on admission, transfer to a center with a neonatal ICU, or discharge with outpatient follow-up.
CLINICAL EVIDENCE
Tool for the detection of early cervical remodeling based on the analysis of a cervical image obtained by ultrasound (quantusPREMATURITY).
The tool performs an automated test based on cervical texture analysis by ultrasound to predict the risk of spontaneous preterm birth (sPTB), both alone and in combination with cervical length (CL). quantusPREMATURITY is composed of three modules:
The results obtained by the tool, compared with CL for the detection of sPTB, evaluated separately for before weeks 34 and 37, are as follows:
| < 34+0 weeks | Sensitivity | Specificity | PPV** | NPV** |
|---|---|---|---|---|
| CL* | 14.3% | 99.4% | 20.0% | 99.0% |
| quantusPREMATURITY | 28.6% | 99.5% | 40.0% | 99.2% |
| quantusPREMATURITY + CL | 42.9% | 98.9% | 30.0% | 99.4% |
| < 37+0 weeks | Sensitivity | Specificity | PPV** | NPV** |
|---|---|---|---|---|
| CL* | 8.7% | 99.5% | 40.0% | 96.7% |
| quantusPREMATURITY | 21.7% | 99.4% | 55.6% | 97.1% |
| quantusPREMATURITY + CL* | 30.4% | 89.9% | 50.0% | 97.4% |
* CL: Cervical length
** PPV and NPV: Positive Predictive Value and Negative Predictive Value
SOLUTION INTEGRATION
- Our products allow integration with client systems through the DICOM protocol and the HL7 FHIR interface
- We ensure data privacy in SaaS installations by establishing IPsec VPNs with our clients.
- All communications outside the client environment are secured with SSL TLS 1.3
LICENSING BY NUMBER OF TESTS
LICENSING BY ANALYSES PERFORMED
CUSTOM OFFERS
