We are glad to announce that the IOTA apps are returning.

• The ADNEX and M6 apps are coming back
• A brand-new IETA app is being launched

The staged roll-out is already ongoing, starting in the UK, and expanding to Europe, the USA, and beyond.

Why the apps were removed

The previous IOTA calculators (ADNEX, LR1, LR2, and SRRisk) were taken down from the IOTA website and app stores due to the European Medical Device Regulation (MDR). Under MDR, diagnostic decision support software is classified as a medical device, which requires formal certification before it can be legally distributed.

To provide context, the original letter from the IOTA Steering Committee at the time the apps were removed is included at the bottom of this page.

Creation of Gynaia, IOTA Spin-off

This regulatory change led to the creation of Gynaia. Gynaia is the new legal manufacturer, spun out of KU Leuven, UZ Leuven, and the IOTA consortium. Its mission is to bring the IOTA models back as certified medical devices and to provide the professional ecosystem needed around them.

Membership and access

Because these decision support tools are medical devices, they must be used by trained healthcare professionals. Access requires proof of proficiency, which is why IOTA and Gynaia together developed structured educational programmes offered as recurring memberships.

What Gynaia does

Through a low-cost annual membership, professionals gain access not only to the apps, but also to a complete educational and support offering. Membership includes continuous education and updated learning materials, access to a constantly expanding case database, and participation in a quality control programme to assess proficiency and image quality. Members also benefit from webinars, interactive case streams, and dedicated professional support.

Beyond access and training, Gynaia manages the full medical device lifecycle of the IOTA models, supports validation studies and clinical trials with Clinical Data Miner, and provides a professional Learning Management System with best-in-class course materials developed together with the IOTA Editorial Board.

In summary

The IOTA apps are returning: stronger, certified, and embedded in a complete educational and clinical ecosystem. If you’d like to learn more about the membership programme, click here www.gynaia.com or contact info@gynaia.com .

Model unavailability - IOTA Message

Dear Colleague, 

We are writing to you to explain why the web applications of ADNEX and of LR1, LR2 and SRRisk are no longer available on the IOTA website, and why the ADNEX app and the other IOTA apps are no longer available in app-store or Google play. The explanation is a change in the European Medical Device Regulation (MDR), a set of regulations that governs the sale and distribution of medical devices within the European Union (EU).

According to the new MDR, the ADNEX calculator and the other IOTA calculators (web-application, app for apple and android devices and any other applications of the IOTA calculators) are now classified as medical devices. As a result, these calculators must undergo a certification process before they can be legally made available to healthcare professionals. Therefore, we have suspended the availability of the ADNEX calculator and the other calculators on our website until we have received the required certification, and we have also removed them from app-store and google play.

The process of obtaining MDR certification for medical devices is complex, very expensive and time-consuming. The IOTA steering committee is now working hard to obtain certification of the ADNEX web application, but we cannot provide reliable information on how long this process may take.

Please, observe that it is not the ADNEX model itself that is questioned and needs "certification". The ADNEX model has been externally validated on thousands of patients in different countries and settings and has been shown to have excellent ability to discriminate between benign and maligant adenxal masses. It is the calculator itself (web-application or app for android and apple devises) that needs to obtain certification.

An ADNEX app and some of the other IOTA risk calculation apps are available in many ultrasound systems. The apps in ultrasound systems have the necessary certification according to the manufacturers of the ultrasound machines. If you do not have an ultrasound machine with the ADNEX app or any of the other IOTA apps, we suggest you use the IOTA Benign descriptors or the IOTA Simple Rules.

We are very sorry about the situation. We know it causes substantial inconvenience.

If you have any questions or concerns, please contact us. We will keep you informed about any updates regarding the availability of the IOTA calculators.

Thank you for your understanding and continued support.

 

Sincerely,

 

The IOTA Steering Committee:
Dirk Timmerman
Lil Valentin
Tom Bourne
Antonia Testa
Wouter Froyman
Ben van Calster