Avant Technologies and Ainnova Request Pre-Submission Meeting with US FDA for VisionAI Platform Technology
Avant Technologies (OTCQB: AVAI) and its joint venture partner Ainnova Tech have reached a significant milestone in their regulatory journey by requesting a pre-submission meeting with the FDA for their VisionAI platform technology.
The technology, focused on early detection of diabetic retinopathy, will be reviewed by the FDA's Center for Devices and Radiological Health. The companies aim to obtain FDA 510(k) clearance to market the technology in the U.S. through their partnership entity, Ai-nova Acquisition Corp (AAC).
Key points:
- AAC holds worldwide licensing rights for VisionAI platform and retinal cameras
- The strategy includes rapid deployment in low-regulation markets while pursuing FDA clearance
- Pre-submission meeting will help determine clinical trial requirements and budget planning
- Success with FDA is crucial for U.S. market entry and commercial potential
Avant Technologies (OTCQB: AVAI) e il suo partner in joint venture Ainnova Tech hanno raggiunto un importante traguardo nel loro percorso regolatorio richiedendo un incontro preliminare con la FDA per la loro tecnologia VisionAI.
Questa tecnologia, focalizzata sulla diagnosi precoce della retinopatia diabetica, sarà valutata dal Centro per i Dispositivi e la Salute Radiologica della FDA. Le aziende mirano a ottenere l'autorizzazione FDA 510(k) per commercializzare la tecnologia negli Stati Uniti tramite la loro entità di partnership, Ai-nova Acquisition Corp (AAC).
Punti chiave:
- AAC detiene i diritti di licenza mondiali per la piattaforma VisionAI e le fotocamere retiniche
- La strategia prevede un rapido lancio nei mercati con regolamentazioni meno stringenti mentre si procede con l'ottenimento dell'autorizzazione FDA
- L'incontro preliminare aiuterà a definire i requisiti per gli studi clinici e la pianificazione del budget
- Il successo con la FDA è fondamentale per l'ingresso nel mercato USA e il potenziale commerciale
Avant Technologies (OTCQB: AVAI) y su socio en empresa conjunta Ainnova Tech han alcanzado un hito importante en su proceso regulatorio al solicitar una reunión previa con la FDA para su tecnología VisionAI.
La tecnología, centrada en la detección temprana de la retinopatía diabética, será revisada por el Centro de Dispositivos y Salud Radiológica de la FDA. Las compañías buscan obtener la autorización FDA 510(k) para comercializar la tecnología en EE.UU. a través de su entidad asociada, Ai-nova Acquisition Corp (AAC).
Puntos clave:
- AAC posee los derechos de licencia mundial para la plataforma VisionAI y las cámaras retinianas
- La estrategia incluye un despliegue rápido en mercados con regulaciones menos estrictas mientras se persigue la autorización FDA
- La reunión previa ayudará a determinar los requisitos de ensayos clínicos y la planificación del presupuesto
- El éxito con la FDA es crucial para la entrada al mercado estadounidense y el potencial comercial
Avant Technologies (OTCQB: AVAI)와 공동 벤처 파트너 Ainnova Tech는 VisionAI 플랫폼 기술에 대해 FDA와 사전 제출 미팅을 요청하며 중요한 규제 이정표를 달성했습니다.
이 기술은 당뇨병성 망막병증의 조기 발견에 중점을 두고 있으며, FDA의 의료기기 및 방사선 건강 센터에서 검토받게 됩니다. 양사는 파트너십 법인인 Ai-nova Acquisition Corp (AAC)를 통해 미국 시장에서 이 기술을 판매하기 위한 FDA 510(k) 승인 취득을 목표로 하고 있습니다.
주요 내용:
- AAC는 VisionAI 플랫폼과 망막 카메라에 대한 전 세계 라이선스 권리를 보유하고 있습니다
- 전략은 FDA 승인 절차를 진행하는 동안 규제가 덜한 시장에서의 신속한 배포를 포함합니다
- 사전 제출 미팅은 임상 시험 요구 사항과 예산 계획을 결정하는 데 도움을 줄 것입니다
- FDA 승인 성공은 미국 시장 진입과 상업적 잠재력에 매우 중요합니다
Avant Technologies (OTCQB : AVAI) et son partenaire en coentreprise Ainnova Tech ont franchi une étape importante dans leur parcours réglementaire en demandant une réunion de pré-soumission avec la FDA pour leur technologie de plateforme VisionAI.
Cette technologie, axée sur la détection précoce de la rétinopathie diabétique, sera examinée par le Centre des dispositifs et de la santé radiologique de la FDA. Les entreprises visent à obtenir l'autorisation FDA 510(k) pour commercialiser la technologie aux États-Unis via leur entité partenaire, Ai-nova Acquisition Corp (AAC).
Points clés :
- AAC détient les droits de licence mondiaux pour la plateforme VisionAI et les caméras rétiniennes
- La stratégie inclut un déploiement rapide sur les marchés à faible réglementation tout en poursuivant l'autorisation FDA
- La réunion de pré-soumission aidera à déterminer les exigences des essais cliniques et la planification budgétaire
- La réussite auprès de la FDA est cruciale pour l'entrée sur le marché américain et le potentiel commercial
Avant Technologies (OTCQB: AVAI) und ihr Joint-Venture-Partner Ainnova Tech haben einen wichtigen Meilenstein in ihrem regulatorischen Prozess erreicht, indem sie ein Vorab-Einreichungsgespräch mit der FDA für ihre VisionAI-Plattformtechnologie beantragt haben.
Die Technologie, die sich auf die Früherkennung der diabetischen Retinopathie konzentriert, wird vom FDA-Zentrum für Geräte und radiologische Gesundheit überprüft. Die Unternehmen streben an, eine FDA 510(k)-Freigabe zu erhalten, um die Technologie in den USA über ihre Partnergesellschaft, Ai-nova Acquisition Corp (AAC), zu vermarkten.
Wichtige Punkte:
- AAC hält weltweite Lizenzrechte für die VisionAI-Plattform und Netzhautkameras
- Die Strategie umfasst eine schnelle Markteinführung in Märkten mit geringerer Regulierung während des FDA-Zulassungsprozesses
- Das Vorab-Einreichungsgespräch soll helfen, klinische Studienanforderungen und Budgetplanung festzulegen
- Der Erfolg bei der FDA ist entscheidend für den Markteintritt in den USA und das kommerzielle Potenzial
- FDA pre-submission package for VisionAI platform accepted for review
- Worldwide licensing rights secured for VisionAI platform and retinal cameras through AAC joint venture
- Two-tier market strategy: immediate deployment in low-regulation markets while pursuing FDA clearance
- Strategic positioning for U.S. market entry through FDA regulatory pathway
- Additional clinical trials required before FDA clearance, indicating time and cost investments ahead
- Budget for FDA process not yet defined
- Currently operating in OTC market (OTCQB) rather than major exchange
Ainnova is requesting a pre-submission meeting with the FDA's review team to discuss any questions and/or concerns about its proposed formal submission, including seeking advice to finalize the protocol and obtain agency guidance for a clinical trial of its VisionAI platform in the early detection of diabetic retinopathy. A pre-submission meeting allows companies to clarify regulatory requirements, get feedback on their plans, and potentially avoid delays or issues during the formal review process.
The clinical studies will aim to support an FDA 510(k) submission to obtain clearance from the regulatory agency to market its technology in the
Ai-nova Acquisition Corp. (AAC), the company formed by the partnership between Avant and Ainnova to advance and commercialize Ainnova's technology portfolio, including its VisionAI platform and its versatile retinal cameras, has worldwide licensing rights for this portfolio. The licensing rights include the
Vinicio Vargas, Chief Executive Officer at Ainnova and a member of AAC's Board of Directors, said, "This milestone reflects our two-tiered strategy, rapid deployment in low-regulation markets where VisionAI operates as a screening tool, and simultaneous progress toward FDA clearance for the
For medical device applicants like Ainnova, the FDA's pre-submission program is useful to determine a clear regulatory pathway for the successful launch of the device, including the number of patients and the number of clinics that will be needed to generate the necessary clinical data for the FDA to make an informed decision on Ainnova's VisionAI platform. For Avant, the pre-submission meeting will help define a precise budget for the strategic partnership's entire FDA process.
About Ainnova Tech, Inc.
Ainnova is a
About Avant Technologies, Inc.
Avant Technologies, Inc. is an emerging technology company developing solutions in artificial intelligence in healthcare. With a focus on pushing the boundaries of what is possible in AI and machine learning, Avant serves a diverse range of industries, driving progress and efficiency through state-of-the-art technology.
More information about Avant can be found at https://avanttechnologies.com
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