Medtronic advances Abbott CGM partnership with FDA submission of interoperable insulin pump
Medtronic (NYSE: MDT) has submitted 510(k) applications to the FDA for clearance of an interoperable insulin pump system that would integrate with Abbott's advanced CGM platform. The submission includes the MiniMed™ 780G pump as an alternate controller enabled (ACE) insulin pump and the SmartGuard™ algorithm as an interoperable automated glycemic controller (iAGC).
This development follows last August's collaboration announcement between Medtronic and Abbott. Under the partnership, Abbott will provide Medtronic with CGM technology that will work exclusively with Medtronic's smart dosing devices and software for both automated insulin delivery and smart multiple daily injections systems. These integrated systems will be marketed solely by Medtronic.
Medtronic (NYSE: MDT) ha presentato all'FDA le domande 510(k) per l'autorizzazione di un sistema interoperabile di pompe per insulina che si integrerà con la piattaforma avanzata di CGM di Abbott. La richiesta include la pompa MiniMed™ 780G come pompa per insulina abilitata come controllore alternativo (ACE) e l'algoritmo SmartGuard™ come controllore glicemico automatizzato interoperabile (iAGC).
Questo sviluppo segue l'annuncio di collaborazione dello scorso agosto tra Medtronic e Abbott. Nell'ambito della partnership, Abbott fornirà a Medtronic la tecnologia CGM che funzionerà esclusivamente con i dispositivi intelligenti di dosaggio e il software di Medtronic, sia per la somministrazione automatica di insulina sia per i sistemi intelligenti di iniezioni multiple giornaliere. Questi sistemi integrati saranno commercializzati unicamente da Medtronic.
Medtronic (NYSE: MDT) ha presentado solicitudes 510(k) a la FDA para la autorización de un sistema interoperable de bombas de insulina que se integrará con la plataforma avanzada de CGM de Abbott. La presentación incluye la bomba MiniMed™ 780G como bomba de insulina habilitada como controlador alternativo (ACE) y el algoritmo SmartGuard™ como controlador glucémico automatizado interoperable (iAGC).
Este desarrollo sigue al anuncio de colaboración del pasado agosto entre Medtronic y Abbott. Bajo esta asociación, Abbott proporcionará a Medtronic la tecnología CGM que funcionará exclusivamente con los dispositivos inteligentes de dosificación y el software de Medtronic, tanto para la administración automatizada de insulina como para sistemas inteligentes de inyecciones múltiples diarias. Estos sistemas integrados serán comercializados únicamente por Medtronic.
메드트로닉 (NYSE: MDT)은 애보트의 첨단 CGM 플랫폼과 통합되는 상호운용 인슐린 펌프 시스템의 FDA 510(k) 승인 신청서를 제출했습니다. 제출된 내용에는 대체 제어기 활성화(ACE) 인슐린 펌프로서의 MiniMed™ 780G 펌프와 상호운용 자동 혈당 조절기(iAGC)로서의 SmartGuard™ 알고리즘이 포함되어 있습니다.
이번 개발은 지난 8월 메드트로닉과 애보트 간의 협력 발표에 따른 것입니다. 이 파트너십에 따라 애보트는 메드트로닉의 스마트 투여 장치 및 자동 인슐린 전달과 스마트 다회 주사 시스템용 소프트웨어와 독점적으로 작동하는 CGM 기술을 제공할 예정입니다. 이 통합 시스템은 메드트로닉에서만 판매됩니다.
Medtronic (NYSE : MDT) a soumis des demandes 510(k) à la FDA pour l'autorisation d'un système de pompe à insuline interopérable qui s'intégrera à la plateforme avancée de CGM d'Abbott. La soumission comprend la pompe MiniMed™ 780G en tant que pompe à insuline activée par contrôleur alternatif (ACE) et l'algorithme SmartGuard™ en tant que contrôleur glycémique automatisé interopérable (iAGC).
Ce développement fait suite à l'annonce de collaboration d'août dernier entre Medtronic et Abbott. Dans le cadre de ce partenariat, Abbott fournira à Medtronic la technologie CGM qui fonctionnera exclusivement avec les dispositifs de dosage intelligents et les logiciels de Medtronic, tant pour la délivrance automatisée d'insuline que pour les systèmes intelligents d'injections multiples quotidiennes. Ces systèmes intégrés seront commercialisés uniquement par Medtronic.
Medtronic (NYSE: MDT) hat 510(k)-Anträge bei der FDA für die Zulassung eines interoperablen Insulinpumpensystems eingereicht, das sich mit Abbotts fortschrittlicher CGM-Plattform integrieren lässt. Die Einreichung umfasst die MiniMed™ 780G Pumpe als Alternate Controller Enabled (ACE) Insulinpumpe und den SmartGuard™ Algorithmus als interoperablen automatisierten glykämischen Regler (iAGC).
Diese Entwicklung folgt auf die im letzten August bekannt gegebene Zusammenarbeit zwischen Medtronic und Abbott. Im Rahmen der Partnerschaft wird Abbott Medtronic mit CGM-Technologie versorgen, die ausschließlich mit Medtronics intelligenten Dosiergeräten und Software für automatisierte Insulinabgabe sowie intelligente Mehrfach-Tagesinjektionssysteme funktioniert. Diese integrierten Systeme werden ausschließlich von Medtronic vermarktet.
- FDA clearance would expand MDT's product portfolio with integrated CGM solutions
- Exclusive distribution rights for the integrated system
- Strategic partnership with Abbott enhances competitive position in diabetes care
- FDA approval remains uncertain
- Timeline for potential clearance not specified
- Success of the integrated system dependent on regulatory approval
Insights
Medtronic's FDA submission for interoperable insulin pump marks concrete progress in Abbott partnership, expanding its diabetes technology ecosystem.
This 510(k) submission to the FDA represents a significant regulatory milestone in Medtronic's diabetes technology roadmap. The company has submitted two key applications: one for their MiniMed 780G pump as an alternate controller enabled (ACE) insulin pump and another for their SmartGuard algorithm as an interoperable automated glycemic controller (iAGC). These submissions are designed to enable integration with Abbott's advanced CGM platform.
The diabetes technology landscape has been increasingly moving toward interoperability, allowing patients to mix and match components from different manufacturers. Historically, Medtronic maintained a closed ecosystem approach, which sensor options for their pump users. This partnership addresses a significant gap in Medtronic's product strategy by providing access to Abbott's established CGM technology without developing a new sensor internally.
The exclusivity arrangement mentioned in the article - where Abbott will supply a CGM working exclusively with Medtronic's systems and sold solely by Medtronic - indicates a carefully structured partnership that maintains Medtronic's position as the customer-facing entity while expanding technology options. For patients with diabetes who prefer Medtronic's pump technology but want alternative sensor options, this integration could potentially provide meaningful benefits if approved.
Medtronic's FDA submission advances strategic Abbott partnership, potentially strengthening its competitive position against rivals in diabetes technology.
This regulatory submission represents tangible execution on the strategic partnership Medtronic announced with Abbott last August. In the competitive diabetes technology market, Medtronic has faced challenges from rivals offering more open platforms with greater interoperability. This move directly addresses that competitive weakness by potentially expanding Medtronic's ecosystem to include Abbott's CGM technology.
The structure of the partnership is particularly noteworthy - Abbott will supply Medtronic with a CGM based on its advanced platform that will work exclusively with Medtronic's dosing devices and software. Furthermore, these integrated systems will be sold exclusively by Medtronic. This arrangement allows Medtronic to maintain control of the customer relationship and distribution channels while addressing the demand for more sensor choices.
For Medtronic's diabetes business strategy, this represents a pragmatic approach to enhance its product portfolio without the extended timeline of internal CGM development. The partnership leverages the complementary strengths of both companies - Medtronic's insulin delivery systems and algorithm expertise combined with Abbott's sensor technology. While FDA clearance is never guaranteed, this submission demonstrates concrete progress toward delivering on previously announced strategic objectives and potentially strengthening Medtronic's competitive positioning in the
The submissions included a 510(k) application for its MiniMed™ 780G pump as an alternate controller enabled (ACE) insulin pump and a separate 510(k) application for its SmartGuard™ algorithm as an interoperable automated glycemic controller (iAGC).
"We understand how meaningful these advancements are, and we're working with urgency to bring enhanced CGM options to our customers," said Que Dallara, EVP & president, Medtronic Diabetes. "This collaboration with Abbott marks an important step forward in providing innovative solutions and more choice for our customers."
This milestone follows the announcement last August that the companies will collaborate on an integrated system based on Abbott's most advanced CGM platform. Abbott will supply Medtronic with a CGM that will work exclusively with Medtronic smart dosing devices and software across both automated insulin delivery and smart multiple daily injections systems. These systems, including the Abbott CGM, will be sold exclusively by Medtronic.
More details will be shared when FDA clearance is secured.
About the Diabetes Business at Medtronic (www.medtronicdiabetes.com)
Medtronic Diabetes is on a mission to alleviate the burden of diabetes by empowering individuals to live life on their terms, with the most advanced diabetes technology and always-on support when and how they need it. We've pioneered first-of-its-kind innovations for over 40 years and are committed to designing the future of diabetes management through next-generation sensors (CGM), intelligent dosing systems, and the power of data science and AI while always putting the customer experience at the forefront.
About Medtronic
Bold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in
Any forward-looking statements, including, but not limited to, statements regarding the partnership between Medtronic and Abbott, strategic and other potential benefits of the partnership, Abbott's products and product candidates, and other statements about Medtronic managements' future expectations, beliefs, goals, plans or prospects, are subject to risks and uncertainties including, but not limited to, the ability to obtain regulatory approvals, and other risks and uncertainties such as those described in Medtronic's reports and other filings with the Securities and Exchange Commission. Actual results may differ materially from anticipated results. Medtronic cautions investors not to place considerable reliance on the forward-looking statements contained in this press release. These forward-looking statements speak only as of the date of this document, and Medtronic undertakes no obligation to update or revise any of these statements except to the extent required by law.
Contacts:
Janet Cho
Public Relations
+1-818-403-7028
Ryan Weispfenning
Investor Relations
+1-763-505-4626
View original content to download multimedia:https://www.prnewswire.com/news-releases/medtronic-advances-abbott-cgm-partnership-with-fda-submission-of-interoperable-insulin-pump-302437337.html
SOURCE Medtronic plc
FAQ
What is the significance of Medtronic's FDA submission for the interoperable insulin pump?
What products are included in MDT's 510(k) FDA submission?
How will the Abbott-Medtronic partnership affect product distribution?
When was the Abbott-Medtronic CGM partnership first announced?
