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Relu ottiene la certificazione FDA 510(k) e l'approvazione del marchio CE per il rivoluzionario strumento Relu® Creator
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Relu

Oct 01, 2024, 04:00 ET

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LOVANIO, Belgio, 1 ottobre 2024 /PRNewswire/ -- Relu, pioniere nelle soluzioni di intelligenza artificiale per laboratori odontotecnici e software providers, annuncia con orgoglio il duplice ottenimento della certificazione 510(k) da parte della Food and Drug Administration (FDA) statunitense e dell'approvazione del marchio CE da parte di un Organismo Notificato dell'UE. Queste tappe normative autorizzano la distribuzione commerciale di Relu® Creator, lo strumento odontoiatrico all'avanguardia che consente agli utenti di creare modelli anatomici 3D in pochi minuti.

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RELU CREATOR CE FDA
RELU CREATOR CE FDA

La certificazione FDA 510(k) indica la conformità agli standard statunitensi in materia di dispositivi medici, mentre il marchio CE conferma l'adesione alle normative dell'Unione Europea in materia di sicurezza dei prodotti e protezione dei consumatori. Questo doppio riconoscimento sottolinea l'impegno di Relu verso l'eccellenza globale e la cura dei pazienti nel settore della salute orale.

"Siamo entusiasti di aver ottenuto l'approvazione della FDA e del marchio CE per Relu® Creator", ha dichiarato Adriaan Van Gerven, CTO e cofondatore di Relu. "Questi importanti risultati testimoniano la dedizione di Relu allo sviluppo di una tecnologia superiore che soddisfa i più elevati standard internazionali di sicurezza e qualità. Siamo pronti a rivoluzionare gli studi dentistici e l'esperienza dei pazienti negli Stati Uniti e nell'Unione Europea".

"Questa approvazione apre la strada all'ingresso della nostra tecnologia avanzata nei mercati dentali degli Stati Uniti e dell'Unione Europea, entrambi noti per le loro normative rigorose e l'elevato potenziale di crescita. Avendo guidato la strategia nei settori degli impianti e dell'ortodonzia, ritengo che questo risultato rappresenti un elemento di differenziazione fondamentale che contraddistingue Relu® Creator. Si tratta di un importante passo avanti nella nostra missione di modernizzazione delle cure dentali e di responsabilizzazione", ha dichiarato Bindu Saran, ex Responsabile Globale della Orthodontic Technology  presso Straumann, ex Responsabile Senior della Ricerca e Sviluppo presso Ormco e Membro del Consiglio di Amministrazione di Relu.

Relu® Creator integra vari sistemi di intelligenza artificiale all'avanguardia per offrire funzioni quali l'analisi in tempo reale, l'identificazione automatica delle strutture anatomiche e l'imaging 3D per la diagnostica e la pianificazione del trattamento dentale. Migliorando la precisione e l'efficienza delle procedure odontoiatriche, Relu® Creator è destinato a diventare uno strumento essenziale per le moderne cliniche dentali.

Informazioni su Relu

Relu è stata fondata nel 2019 con il sogno di rendere i trattamenti dentali più sicuri e veloci. Include avanzati sistemi di visione artificiale e di intelligenza artificiale per automatizzare i processi di lavoro manuali. I loro Relu® Engine e Relu® Creator sono utilizzati dai laboratori odontotecnici e dai partner software per più di migliaia di trattamenti ortodontici e implantari al giorno. Relu ha sede a Lovanio, in Belgio, e un ufficio a Boston, MA, USA. Per saperne di più: relu.eu

© 2024 Relu

Foto: https://mma.prnewswire.com/media/2503063/Relu.jpg
Logo: https://mma.prnewswire.com/media/2038266/Relu_Logo.jpg

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