GlucoGuard Files Breakthrough Device Application with US Food and Drug Administration
GlucoGuard, a subsidiary of American Diversified Holdings (OTC Pink: ADHC), has filed an application with the FDA seeking Breakthrough Device designation. The company has received initial feedback confirming the application's qualification for review.
The Breakthrough Devices Program aims to accelerate development, assessment, and review processes for premarket approval, 510(k) clearance, and De Novo marketing authorization, while maintaining strict safety and effectiveness standards. This development follows GlucoGuard's recent announcement regarding Continuous Glucose Monitoring (CGM) collaboration with development partner Dexcomm.
The company reports ongoing negotiations with Investment Partners, with future updates promised to shareholders.
GlucoGuard, una filiale di American Diversified Holdings (OTC Pink: ADHC), ha presentato una domanda alla FDA per ottenere la designazione di Dispositivo Innovativo. L'azienda ha ricevuto un feedback iniziale che conferma la qualificazione della domanda per la revisione.
Il Programma Dispositivi Innovativi mira ad accelerare i processi di sviluppo, valutazione e revisione per l'approvazione pre-commerciale, il nulla osta 510(k) e l'autorizzazione al marketing De Novo, mantenendo al contempo rigorosi standard di sicurezza ed efficacia. Questo sviluppo segue l'annuncio recente di GlucoGuard riguardante la collaborazione per il Monitoraggio Continuo della Glucosio (CGM) con il partner di sviluppo Dexcomm.
L'azienda riferisce di essere in trattative con Partner di Investimento, con aggiornamenti futuri promessi agli azionisti.
GlucoGuard, una subsidiaria de American Diversified Holdings (OTC Pink: ADHC), ha presentado una solicitud ante la FDA buscando la designación de Dispositivo Innovador. La compañía ha recibido comentarios iniciales que confirman la calificación de la solicitud para su revisión.
El Programa de Dispositivos Innovadores tiene como objetivo acelerar los procesos de desarrollo, evaluación y revisión para la aprobación previa al mercado, la autorización 510(k) y la autorización de comercialización De Novo, manteniendo al mismo tiempo estrictos estándares de seguridad y eficacia. Este desarrollo sigue al anuncio reciente de GlucoGuard sobre la colaboración en Monitoreo Continuo de Glucosa (CGM) con el socio de desarrollo Dexcomm.
La compañía informa que está en negociaciones con Socios de Inversión, prometiendo actualizaciones futuras a los accionistas.
GlucoGuard는 American Diversified Holdings (OTC Pink: ADHC)의 자회사로, FDA에 혁신 기기 지정을 요청하는 신청서를 제출했습니다. 회사는 신청서가 검토 자격을 갖추었다는 초기 피드백을 받았습니다.
혁신 기기 프로그램은 시장 승인, 510(k) 승인 및 De Novo 마케팅 허가를 위한 개발, 평가 및 검토 프로세스를 가속화하는 것을 목표로 하며, 엄격한 안전성과 효과 기준을 유지합니다. 이 개발은 GlucoGuard가 개발 파트너 Dexcomm과의 지속적인 혈당 모니터링(CGM) 협력에 대한 최근 발표를 따릅니다.
회사는 투자 파트너와의 지속적인 협상이 진행 중이며, 주주들에게 향후 업데이트를 약속했습니다.
GlucoGuard, une filiale d'American Diversified Holdings (OTC Pink: ADHC), a déposé une demande auprès de la FDA pour obtenir la désignation de Dispositif Innovant. L'entreprise a reçu des retours initiaux confirmant la qualification de la demande pour examen.
Le Programme des Dispositifs Innovants vise à accélérer les processus de développement, d'évaluation et d'examen pour l'approbation préalable à la commercialisation, l'autorisation 510(k) et l'autorisation de mise sur le marché De Novo, tout en maintenant des normes strictes de sécurité et d'efficacité. Ce développement fait suite à l'annonce récente de GlucoGuard concernant une collaboration en matière de Surveillance Continue de la Glucose (CGM) avec le partenaire de développement Dexcomm.
L'entreprise rapporte être en négociations avec des Partenaires d'Investissement, avec des mises à jour futures promises aux actionnaires.
GlucoGuard, eine Tochtergesellschaft von American Diversified Holdings (OTC Pink: ADHC), hat einen Antrag bei der FDA auf die Auszeichnung als Durchbruchgerät eingereicht. Das Unternehmen hat erste Rückmeldungen erhalten, die die Qualifikation des Antrags zur Überprüfung bestätigen.
Das Durchbruchgeräte-Programm zielt darauf ab, die Entwicklung, Bewertung und Überprüfungsprozesse für die Marktzulassung, die 510(k)-Genehmigung und die De Novo-Marktzulassung zu beschleunigen und dabei strenge Sicherheits- und Wirksamkeitsstandards aufrechtzuerhalten. Diese Entwicklung folgt auf die kürzliche Ankündigung von GlucoGuard bezüglich der Zusammenarbeit im Bereich des kontinuierlichen Glukosemonitorings (CGM) mit dem Entwicklungspartner Dexcomm.
Das Unternehmen berichtet von laufenden Verhandlungen mit Investitionspartnern und verspricht zukünftige Updates für die Aktionäre.
- FDA confirms qualification for Breakthrough Device application review
- Strategic partnership with Dexcomm for CGM development
- Ongoing negotiations with Investment Partners
- FDA review outcome still pending
- Timeline for FDA decision not specified
Del Mar, California--(Newsfile Corp. - February 26, 2025) - American Diversified Holdings Corporation (OTC Pink: ADHC) announced today that GlucoGuard has filed an application with the FDA seeking to be designated as a Breakthrough Device.
The Breakthrough Devices Program is intended to provide patients and health care providers with timely access to medical devices by speeding up development, assessment, and review for premarket approval, 510(k) clearance, and De Novo marketing authorization. Breakthrough Devices must meet the FDA's rigorous standards for device safety and effectiveness in order to be authorized for marketing. The Breakthrough Devices Program reflects the FDA's commitment to device innovation and protecting the public health.
"We have received initial feedback back from the FDA indicating the application is qualified for review, we expect to hear back with comments from the reviewer in the near future and are optimistic that the GlucoGuard technology presents a compelling case for approval," commented the GlucoGuard team.
This FDA application combined with the recent announcement regarding Continuous Glucose Monitoring (CGM) with development partner Dexcomm has moved the development of this technology along rapidly. More negotiations with Investment Partners are in place and shareholders will be informed in the near future.
See the below link for more information
Breakthrough Devices Program | FDA
About IMD Solutions, Inc. IMD Solutions, Inc. is a Nevada-based medical device company developing GlucoGuard, a patent-pending nocturnal glucose monitoring and delivery system for diabetic patients. The system helps prevent the dangerous effects of low blood sugar during sleep, including the potentially fatal "Death in Bed" phenomenon. Collaborating with a leading U.S. research university, a prominent biomedical engineering firm, and a major CGM company, IMD Solutions is at the forefront of diabetes management technology.
For more information, visit: www.GlucoGuardSleep.com.
Contact: Phone: 817-525-0057
Email: info@GlucoGuardSleep.com
About AMERICAN DIVERSIFIED HOLDINGS CORPORATION
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John Cacchioli, CEO
American Diversified Holdings Corporation
Telephone: (212) 537-5900
Email: JC@American-Diversified.com
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FAQ
What is the status of GlucoGuard's FDA Breakthrough Device application for ADHC?
How does the FDA Breakthrough Device designation benefit ADHC's GlucoGuard development?
What recent partnership has ADHC's GlucoGuard announced for glucose monitoring?
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