∆elta, the app for digitalised cognitive testing based on AI gains CE certification to officially accelerate commercialisation // EIT Digital

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∆elta, the app for digitalised cognitive testing based on AI gains CE certification to officially accelerate commercialisation

"∆elta is an iPad app designed and developed with and for neuropsychologists and independent practitioners."

"∆elta is an iPad app designed and developed with and for neuropsychologists and independent practitioners."

  • ∆elta is a non-invasive diagnosis support tool, hence class 1 and needed to be certified as a medical product
  • ∆elta, the app for digitalised cognitive testing based on AI and diagnosis of cognitive decline (e.g. dementia) launched by the startup ki elements UG, is the result of the EIT Digital innovation activity ELEMENT in 2017.
  • DFKI, as activity lead, provided results in 2017 which led to the creation of ki elements UG, and the prototype app ∆elta, which reduces cognitive assessment time by more than 30% and improves the diagnosis and decision process.

Brussels, December 20, 2018 - EIT Digital’s ELEMENT Digital Wellbeing innovation activity and its startup partner ki elements together plan to launch an app for digitalised cognitive testing based on AI and diagnosis of cognitive decline. The prototype has already been developed and is now ready for commercialisation with its CE Certification.

Jan Alexandersson, CEO of the startup ki elements UG and lead for the ELEMENT activity, explains: "CE Certification is an obligatory hurdle to pass for any medical product sold in the European Economic Area. A CE certified product indicates that the product meets requirements of certain EU legal acts (directives) when it comes to health, safety, and environmental protection standards. These requirements are described in a number of standards that have to be implemented. Depending on the class, the product can be self-certified or has to be certified by a third party. For invasive products, medicine, X-rays, … the certification becomes quite intensive”.

“Since ∆elta is classified as a medical product, the certification is a necessary pre-condition for marketing, and we are thrilled to be able to officially able to commercialise our product with this guarantee for our future customers”, ads Alexandersson.

How the Delta app works:

  • ∆elta records and saves speech data in the setting of cognitive assessments. This allows you to easily re-listen to patients and empowers your professional decisions.
  • ∆elta automatically transcribes answers from cognitive speech tests to keep your attention free for the most important thing: your work with the patient.
  • ∆elta leverages AI and computational linguistics to extract and analyse powerful scientific metrics from patients’ answers.
  • ∆elta gives you comprehensive insight by visualising the extracted metrics. Combined with population cut-off values, this visualisation helps to enrich your professional perspective.
  • ∆elta compiles your test analysis, visualisations and your interpretation/diagnosis into a digital report formatted to your clinic’s guidelines.

Alexandersson continues: "∆elta is an iPad app designed and developed with and for neuropsychologists and independent practitioners. It will also be helpful for professionals involved in studies where cognition is affected, such as medical trials. Delta not only reduces cognitive status screening time by more than 30%, but also improves diagnosis and decision process and quality. We are now ready to make our first steps on our primary market: France, and then Germany”.

ki elements' mission is to provide health professionals with artificial intelligence (AI)-empowered tools as key elements to help them excel in their profession. For clinicians investigating dementia-like diseases, Delta is the perfect tool for executing and managing speech-based cognitive tests.

Dementia is a cognitive disorder, mainly caused by neurodegenerative diseases such as Alzheimer’s disease and strokes. It leads to a loss of autonomy and is associated with significant decrease in quality of life. In 2015, there were 9.9 million new cases of dementia around the world; one every 3 seconds*. However only one in two people suffering from dementia is diagnosed. The number of sufferers is expected to double every 20 years, reaching 68% of the worldwide population by 2050, mostly in low-medium income countries and due, in part, to fewer births and a growing elderly population.

Partners involved in the innovation activity for 2018 are:

  • DFKI GmbH: coordination, technology maturation and business modelling
  • ki elements UG (Hauftungsbeschränkt) (sub-grantee of DFKI GmbH): commercialisation of project results
  • University Clinic of Saarland (Germany): clinical partner. Validation study and data collection. Clinical personnel will be involved.
  • INRIA, Nice: video analysis
  • Innovation Alzheimer (sub-grantee of INRIA): clinical partner. Validation study and data collection. Clinical personnel will be involved.

External partners:

*Source: Alzheimer’s Disease International

The Digital Wellbeing Action Line leverages digital technologies to help people stay healthy (prevention and early detection) or cope with an existing chronic condition. It includes both physical and mental wellbeing. The solutions generally rely on enabling consumers to be well-informed about their wellbeing, change their behaviour and use digital unobtrusive instrumentation to monitor and improve their quality of life, saving high healthcare costs later in life.

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