Dexcom G7 15 Day Receives FDA Clearance: the Longest Lasting Wearable and Most Accurate CGM System
Dexcom (NASDAQ:DXCM) has received FDA clearance for its Dexcom G7 15 Day Continuous Glucose Monitoring System for people over 18 with diabetes in the United States. The new system boasts an impressive 15.5 days of wear time and superior accuracy with an overall MARD of 8.0%.
Key features include waterproof capability, direct Apple Watch connectivity, automated activity logging, and a 12-hour grace period for sensor replacement. The system also offers remote glucose sharing with caregivers and enhanced alert settings.
The company plans to launch Dexcom G7 15 Day in the second half of 2025 and is working with insulin pump partners to ensure compatibility with automated insulin delivery systems. Clinical data presented at the Advanced Technologies and Treatments for Diabetes conference in Amsterdam confirms G7 15 Day as the most accurate CGM for adults.
Dexcom (NASDAQ:DXCM) ha ricevuto l'approvazione della FDA per il suo Dexcom G7 15 Day Continuous Glucose Monitoring System per persone sopra i 18 anni con diabete negli Stati Uniti. Il nuovo sistema vanta un notevole tempo di utilizzo di 15,5 giorni e una precisione superiore con un MARD complessivo dell'8,0%.
Le caratteristiche principali includono la capacità di essere impermeabile, connettività diretta con Apple Watch, registrazione automatizzata delle attività e un periodo di grazia di 12 ore per la sostituzione del sensore. Il sistema offre anche la condivisione remota della glicemia con i caregiver e impostazioni di allerta avanzate.
L'azienda prevede di lanciare il Dexcom G7 15 Day nella seconda metà del 2025 e sta collaborando con i partner di pompe per insulina per garantire la compatibilità con i sistemi di somministrazione automatica dell'insulina. I dati clinici presentati alla conferenza sulle Tecnologie Avanzate e i Trattamenti per il Diabete ad Amsterdam confermano il G7 15 Day come il CGM più preciso per gli adulti.
Dexcom (NASDAQ:DXCM) ha recibido la aprobación de la FDA para su Dexcom G7 15 Day Continuous Glucose Monitoring System para personas mayores de 18 años con diabetes en los Estados Unidos. El nuevo sistema cuenta con un impresionante tiempo de uso de 15,5 días y una precisión superior con un MARD general del 8,0%.
Las características clave incluyen capacidad a prueba de agua, conectividad directa con Apple Watch, registro automático de actividades y un período de gracia de 12 horas para el reemplazo del sensor. El sistema también ofrece la posibilidad de compartir la glucosa de forma remota con los cuidadores y configuraciones de alerta mejoradas.
La empresa planea lanzar el Dexcom G7 15 Day en la segunda mitad de 2025 y está trabajando con socios de bombas de insulina para asegurar la compatibilidad con los sistemas de entrega automática de insulina. Los datos clínicos presentados en la conferencia de Tecnologías Avanzadas y Tratamientos para la Diabetes en Ámsterdam confirman que el G7 15 Day es el CGM más preciso para adultos.
Dexcom (NASDAQ:DXCM)는 미국에서 18세 이상의 당뇨병 환자를 위한 Dexcom G7 15일 지속 혈당 모니터링 시스템에 대해 FDA 승인을 받았습니다. 새로운 시스템은 15.5일의 착용 시간과 8.0%의 전반적인 MARD로 뛰어난 정확성을 자랑합니다.
주요 기능으로는 방수 기능, Apple Watch와의 직접 연결, 자동 활동 기록, 센서 교체를 위한 12시간의 유예 기간이 포함됩니다. 이 시스템은 또한 보호자와의 원격 혈당 공유 및 향상된 알림 설정을 제공합니다.
회사는 2025년 하반기에 Dexcom G7 15 Day를 출시할 계획이며, 자동 인슐린 전달 시스템과의 호환성을 보장하기 위해 인슐린 펌프 파트너와 협력하고 있습니다. 암스테르담에서 열린 당뇨병을 위한 첨단 기술 및 치료 회의에서 발표된 임상 데이터는 G7 15 Day가 성인을 위한 가장 정확한 CGM임을 확인합니다.
Dexcom (NASDAQ:DXCM) a reçu l'approbation de la FDA pour son Dexcom G7 15 Day Continuous Glucose Monitoring System destiné aux personnes de plus de 18 ans atteintes de diabète aux États-Unis. Le nouveau système offre un temps de port impressionnant de 15,5 jours et une précision supérieure avec un MARD global de 8,0%.
Les caractéristiques clés comprennent une capacité étanche, une connectivité directe avec l'Apple Watch, un enregistrement automatique des activités et une période de grâce de 12 heures pour le remplacement du capteur. Le système permet également le partage à distance de la glycémie avec les soignants et des paramètres d'alerte améliorés.
L'entreprise prévoit de lancer le Dexcom G7 15 Day dans la deuxième moitié de 2025 et travaille avec des partenaires de pompes à insuline pour garantir la compatibilité avec les systèmes de délivrance automatique d'insuline. Les données cliniques présentées lors de la conférence sur les technologies avancées et les traitements pour le diabète à Amsterdam confirment que le G7 15 Day est le CGM le plus précis pour les adultes.
Dexcom (NASDAQ:DXCM) hat die FDA-Zulassung für sein Dexcom G7 15 Day Continuous Glucose Monitoring System für Personen über 18 Jahren mit Diabetes in den Vereinigten Staaten erhalten. Das neue System bietet eine beeindruckende Tragezeit von 15,5 Tagen und eine überlegene Genauigkeit mit einem gesamten MARD von 8,0%.
Zu den wichtigsten Funktionen gehören wasserdichte Eigenschaften, direkte Apple Watch-Konnektivität, automatisches Aktivitätsprotokoll und eine 12-stündige Nachfrist für den Sensorwechsel. Das System bietet auch die Möglichkeit des Remote-Glukose-Sharings mit Betreuern und verbesserte Alarm-Einstellungen.
Das Unternehmen plant, den Dexcom G7 15 Day in der zweiten Hälfte des Jahres 2025 auf den Markt zu bringen und arbeitet mit Insulinpumpen-Partnern zusammen, um die Kompatibilität mit automatisierten Insulinabgabesystemen sicherzustellen. Klinische Daten, die auf der Konferenz für fortschrittliche Technologien und Behandlungen für Diabetes in Amsterdam präsentiert wurden, bestätigen, dass der G7 15 Day das genaueste CGM für Erwachsene ist.
- FDA clearance received for extended 15.5-day wear time, reducing monthly sensor changes
- Best-in-class accuracy with 8.0% MARD rating
- Expanded features including waterproof capability and direct Apple Watch connectivity
- Clinical validation as most accurate CGM for adults presented at international conference
- 26% of sensors may not last for the full 15-day period
- Launch delayed until second half of 2025
- Currently to adults 18 and above
Insights
Dexcom has secured a significant FDA clearance for its G7 15 Day CGM system, representing a meaningful advancement in diabetes management technology. The extended 15.5-day wear period addresses a major user pain point by reducing sensor changes by approximately 40% compared to standard 10-day systems, enhancing convenience while decreasing monthly waste and costs.
The system's 8.0% MARD (Mean Absolute Relative Difference) is particularly noteworthy as it represents best-in-class accuracy for CGM systems - a critical factor for reliable glucose monitoring and treatment decisions. This accuracy improvement could potentially reduce the need for confirmatory fingerstick testing and increase confidence in automated insulin delivery systems that rely on CGM data.
From a regulatory perspective, this clearance validates Dexcom's continued innovation in the competitive CGM market. While the commercial launch isn't scheduled until second half of 2025, this approval removes the most significant regulatory barrier and allows the company to maintain its technological leadership position against competitors like Abbott and Medtronic.
The integration capabilities with insulin delivery systems will be crucial for market adoption, as interoperability has become increasingly important in diabetes device ecosystems. The waterproof design and direct Apple Watch connectivity further differentiate this offering in the growing wearable CGM space.
This FDA clearance represents a substantial economic value proposition for multiple stakeholders in diabetes care. For patients, the extended 15-day wear period translates to approximately 24 sensors annually versus 36+ with 10-day systems, potentially reducing annual supply costs by 33%. The improved accuracy (8.0% MARD) further enhances clinical utility and could drive stronger adherence to CGM therapy.
For payers and healthcare systems, longer-wearing sensors address a key cost driver in diabetes management. Each sensor application carries both direct costs (device) and indirect costs (training, waste disposal, potential complications from frequent site changes). The clinical benefits of consistent CGM use are well-established, including lower A1C, reduced hyper- and hypoglycemia and increased time in range - all factors that correlate with reduced long-term complications and hospitalizations.
From a competitive market standpoint, this innovation strengthens Dexcom's value proposition against lower-cost alternatives by emphasizing total value rather than per-unit pricing. The company's focus on maintaining compatibility with automated insulin delivery systems preserves its position within the broader diabetes technology ecosystem.
While the commercial impact won't materialize until late 2025, this advancement represents a strategic extension of Dexcom's product lifecycle and reinforces the company's commitment to continuous innovation in its core CGM technology platform, which has driven its historical growth and market leadership.
- Dexcom G7 15 Day* is now cleared in the US for people age 18 years and above with diabetes.
- Now the longest lasting*,†,1 and most accurate1 CGM system, Dexcom G7 15 Day gives users the knowledge to better control diabetes.
- For people between the ages 2 to 18, Dexcom G7 remains the most accurate2 continuous glucose monitoring system.
Dexcom G7 15 Day is now cleared in the US for people age 18 years and above with diabetes.
“The approval of Dexcom G7 15 Day marks another major innovation for Dexcom,” said Jake Leach, executive vice president and chief operating officer at Dexcom. “By listening to the needs of our users, we’re proud to offer the longest lasting wearable and most accurate CGM, giving people the knowledge to better control their diabetes with our best-in-class technology. This milestone sets a new standard in CGM and is a testament to our continued leadership in glucose biosensing. We look forward to bringing it to market in the second half of this year, but in the meantime, we encourage our users to upgrade to our current G7 system to gain the benefits of the most connected CGM brand in the world.”
New with Dexcom G7 15 Day
- Longest lasting*,†,1 CGM system with 15.5 days of wear.*
-
Best-in-class accuracy1 with an overall MARD of
8.0% .1,3 - Easier glucose management with fewer monthly sensors and reduced monthly waste.
Dexcom G7 features included with Dexcom G7 15 Day
- The only waterproof§ CGM available, keeping you more connected.
- Manage diabetes, hands-free. Connect your sensor directly to your Apple Watch|| so you can leave your iPhone behind and still see your glucose numbers.
- Automated activity logging,# simplified meal logging and new medication logging# help you better understand how activity, food and medications impact your glucose in real time.
- 12-hour grace period to replace finished sensors for a more seamless transition between sessions.
- Innovative and simple mobile app with Dexcom Clarity integration to easily view glucose patterns, trends and statistics via a range of interactive reports.**,††
- Ability to remotely share glucose numbers with caregivers and loved ones for added support and peace of mind.‡‡,9
- Enhanced and customizable alert settings for improved discretion.
“Dexcom G7 15 Day makes managing diabetes even easier with its extended wear and greater accuracy,” said Satish Garg, MD, from Barbara David Center for Diabetes at the University of Colorado School of Medicine. “Data recently released during the 18th international Advanced Technologies and Treatments for Diabetes conference in
Dexcom is working closely with its insulin pump partners to ensure that Dexcom G7 15 Day will be compatible with automated insulin delivery systems upon launch. Dexcom G7 15 Day is expected to launch in the US in the second half of 2025.
Visit Dexcom.com/start to get started with Dexcom G7 today. To learn more about Dexcom G7 15 Day and for additional information about when it will be available in the US, visit Dexcom.com/15day.
About Dexcom
Dexcom empowers people to take control of health through innovative biosensing technology. Founded in 1999, Dexcom has pioneered and set the standard in glucose biosensing for more than 25 years. Its technology has transformed how people manage diabetes and track their glucose, helping them feel more in control and live more confidently.
Dexcom. Discover what you’re made of. For more information, visit www.dexcom.com.
Category: IR
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* A study was conducted to assess the sensor life where
1 Dexcom, Data on File, 2025. 2 Dexcom, Data on File, 2023. 3 Garg SK, et al. Diabetes Technol Ther. 2025. doi: 10.1089/dia.2025.0139. Epub ahead of print. 4 Beck RW, et al. JAMA. 2017;317(4):371-378. 5 Beck RW, et al. Ann Intern Med. 2017;167(6):365-374. 6 Martens T, et al. JAMA. 2021;325(22):2262-2272. 7 Laffel LM, et al. JAMA. 2020;323(23):2388-2396. 8 Welsh JB, et al. J Diabetes Sci Technol. 2024;18(1):143-7. 9 Polonsky WH, et al. Diabetes Technol Ther. 2021;23(3):195-202.
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Investor Contact
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Source: DexCom, Inc.
FAQ
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