Replacing the First Trimester Screening Program with astraia.obstetrics - What is it about?

For more than 20 years, we have worked closely with the Fetal Medicine Foundation (FMF) and have assisted in numerous studies such as the ASPRE trial. The FMF algorithm is integrated into our obstetrics module - astraia.obsterics - and is classified as a medical device.  In return, we have developed The First Trimester Screening Program (FTS), which until now could be downloaded free of charge from the FMF website by all members with a valid FMF certificate  to measure the nuchal translucency (NT) or more.

FTS and astraia.obsterics are completely different products!

First, the FTS only contains the outdated FMF 2012 risk algorithm. In contrast, astraia.obstetrics contains the latest FMF risk algorithm - FMF 2018 risk algorithm - which allows to calculate the pre-eclampsia risk in all three trimesters. Since The First Trimester Screening Program was designed exclusively for the FMF risk calculation, FTS is severely limited in terms of content and functionality - i.e. it is not possible to document other ultrasound examinations (like growth and anomaly scan), laboratory analyses, invasive procedures and more. In addition, FTS can not be extended with add-ons such image viewer, ultrasound device connectivity etc.

Learn more about differences between FTS and astraia.obstetrics

Can I continue to use The First Trimester Screening Program (FTS)?

With immediate effect, FTS can no longer be downloaded from the FMF website and the Fetal Medicine Foundation no longer issues licenses for it. In practice, this means that you can only use the FTS until you have to renew your FMF license as part of your annual FMF audit. The end of life of the FTS is 29 February 2024.

The results of its risk calculations will no longer be legally or medically backed up by the FMF nor NEXUS / ASTRAIA.

Exclusive offer for FMF accredited practitioners

Since the FTS had to be replaced anyway, Prof. Kypros Nicolaides and we decided to go one step further and to exclusively provide all FMF members with a valid FMF license (certificate of competence) in nuchal translucency (NT) measurement with a free full-fledged astraia.obsterics license plus SMA for 6 months valued at 2.299€ + 207€.This offer does replace The First Trimester Screening Program which end of life is set by the FMF UK on February 2024. That means no one can use The First Trimester Screening Program after that date.

Please be aware that your license of The First Trimester Screening Program may terminate earlier, depending the date of it's last renewal. We strongly recommend you upgrade your First Trimester Screening Program to astraia - software for women's health as soon as possible. Towards the end of life we expect a high demand and waiting times to receive your astraia license may increase.

Free of charge astraia.obsterics license for FMF certified users. What does it mean exactly?

Practitioners holding a valid FMF certificate are eligible to acquire a free astraia.obstetrics license worth a total of 2,300 Euros. Kindly be aware that this offer does not encompass any supplementary reporting modules or add-ons, including the image viewer, image server, ultrasound machine connectivity, laboratory interface, and integration with the hospital information system or patient administration system. These products remain accessible to you; however, they will incur standard additional charges.

The astraia.obstetrics standalone version can be installed and set up by yourself without any difficulty. Detailed instructions on how to do this can be found in the FMF Members Area. If you still wish to seek assistance from the astraia support team, you may do so but you will be charged for the time and effort involved. This also applies for assistance with migrating a database, for example, if you wish to transfer the patient database of your current FTS installation to your new astraia.obstetrics.

Why do I still have to pay for Software Maintenance?

As is standard for medical devices, you have to accept to terms and conditions that include Software Maintenance (SMA). Due to the certification of our software as a class IIa medical device, it is necessary for us to implement a maintenance fee.

The SMA fee of 414 EURO + VAT per year will be charged for the first time, 6 months after issuing your license (i.e. SMA fee is waived for the first six months). By agreeing to SMA, you are eligible for future updates with medical and technical improvements, as well as for technical support. Detailed information on the terms and conditions can be found here.

How do I get my free astraia.obsterics license?

It is very simple for the free standalone version. First you need to register with us to get access to the FMF Members Area. You will require you to attach your FMF licence for NT measurement so that we can check whether it is valid. You will then receive the account activation notification for the FMF Members Area within 3 working days, from where you can download the astraia.obsterics module. The FMF Members Area contains detailed descriptions and videos on how to install and use astraia.obsterics.

In case you consider to set up a larger installation with possible interfaces to your ultrasound machine(s), patient information system or other devices. Or you want more users working on the same database or more clinical modules, you should opt for the regular installation. We are happy to give you a personal consultation to offer you a tailored solution.

Are there any regulatory limitations?

astraia.obstetrics is classified as a medical device class IIa (EU-MDR) and the FMF risk calculation for Trisomy 21 as an In-vitro Diagnostic (EU-IVDR). It therefore requires registration in most countries. Although we are represented in over 70 countries, it may be that the astraia software is not yet available in your country. If this is indeed the case, we will try our utmost to get astraia software registered in your country, in the shortest timeframe possible. However, from our experience, this process can take a while, depending on local regulations. Therefore, please let us know as soon as possible if you would like to get the astraia software so that we can check what this entails and get the process started. We cannot rule out the possibility that registration is impossible. In any case, we will inform you about the current status and, if necessary, work with you to find a solution.