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QuantalX Neuroscience annonce l'approbation CE MDR, rendant l'évaluation de la santé cérébrale disponible dans l'UE
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QuantalX

Feb 12, 2025, 03:00 ET

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La société annonce l'approbation CE MDR pour son nouveau dispositif médical de neurodiagnostic Delphi-MD en vue de sa commercialisation dans l'UE, améliorant ainsi les résultats cliniques et le bien-être des patients tout en réduisant la charge financière des systèmes de soins de santé et des payeurs.

NEW YORK, 12 février 2025 /PRNewswire/ -- QuantalX Neuroscience Ltd. est fière d'annoncer que son dispositif révolutionnaire d'évaluation de la santé cérébrale, le Delphi-MD, a reçu l'approbation CE MDR, la certification de l'Union européenne en vertu du nouveau règlement sur les dispositifs médicaux (MDR). Le processus de certification CE MDR établit une nouvelle référence en matière de sécurité, d'efficacité et de qualité des dispositifs médicaux. Cette réalisation souligne l'engagement de QuantalX en faveur de l'innovation et de l'excellence dans les soins neurologiques.

Delphi-MD Makes Brain Health More Accessible in Europe
Delphi-MD Makes Brain Health More Accessible in Europe

Avec l'approbation CE MDR, QuantalX est prêt à étendre la commercialisation de son test de neurodiagnostic accessible et objectif à toute l'Europe. Le dispositif Delphi-MD sera déployé dans les centres de soins neurologiques, les services de neurologie et les réseaux de santé cérébrale. Delphi-MD permettra d'améliorer l'évaluation de la santé cérébrale, la détection précoce et le diagnostic différentiel de toute anomalie ou maladie cérébrale telle que les accidents vasculaires cérébraux, la maladie de Parkinson, la démence, la maladie d'Alzheimer, l'hydrocéphalie à pression normale (HPN) et d'autres encore, ainsi que la prédiction de la réponse au traitement de chaque patient.

Le vieillissement de la population en Europe entraîne une forte augmentation des maladies neurodégénératives telles que la démence, la maladie de Parkinson et les accidents vasculaires cérébraux. Selon l'Organisation mondiale de la santé (OMS), la prise en charge des 14,1 millions de personnes atteintes de démence en Europe coûtera 439 milliards de dollars en 2019, soit une moyenne de 31 144 dollars (27 815 euros) par patient. La maladie de Parkinson, le trouble neurologique qui connaît la croissance la plus rapide, touche plus de 1,2 million de personnes en Europe, et le nombre de cas devrait augmenter avec le vieillissement de la population. D'ici 2050, le nombre d'Européens âgés de 60 ans et plus devrait augmenter de manière significative, ce qui mettra encore plus à rude épreuve les systèmes de santé et soulignera le besoin urgent de solutions de soins avancées.

Le Dr Iftach Dolev, PDG et cofondateur de QuantalX, a fait part de ses réflexions sur cette réalisation historique : « L'approbation CE MDR valide l'innovation inégalée qui sous-tend notre test de neurodiagnostic. Cela témoigne du dévouement de notre équipe et marque le début d'une nouvelle ère dans le domaine du diagnostic de la santé cérébrale ».

Grâce à sa capacité à permettre une détection précoce et un diagnostic précis des troubles neurologiques, Delphi-MD jouera un rôle crucial dans l'amélioration des résultats et de la qualité de vie des patients, tout en allégeant la charge économique et clinique croissante qui pèse sur les systèmes de santé européens.

À propos de QuantalX Neuroscience

QuantalX s'est engagé à améliorer fondamentalement les soins aux patients et à alléger le fardeau des systèmes de santé grâce à une détection précoce objective et précise et à un diagnostic différentiel des anomalies cérébrales, en s'appuyant sur sa nouvelle technologie neurophysiologique directe, le dispositif Delphi-MD.

Contact avec les médias :
Adi Jacobson
VP Marketing, QuantalX Neuroscience
[email protected]
Tel : +972502043934

Photo - https://mma.prnewswire.com/media/2617703/QuantalX_Delphi_MD.jpg

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QuantalX Neuroscience Announces CE MDR Approval, Making Brain Health Assessment Available in the EU

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QuantalX Neuroscience Ltd. is proud to announce that its groundbreaking brain health assessment device, the Delphi-MD, has received CE MDR approval,...

QuantalX Neuroscience Announces CE MDR Approval, Making Brain Health Assessment Available in the EU

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