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1.Food and Drug Administration . FDA authorizes first interoperable, automated insulin dosing controller designed to allow more choices for patients looking to customize their individual diabetes management device system . https://www.fda.gov/news-events/press-announcements/fda-authorizes-first-interoperable-automated-insulin-dosing-controller-designed-allow-more-choices. Published March 24, 2020. Accessed July 15, 2024 .
2.
Kelm
K.
Re: SmartAdjust Technology 510(k) Premarket Notification of Intent to Market the Device . US FDA ; 2022 . www.accessdata.fda.gov/cdrh_docs/pdf20/K203774.pdf. Accessed July 15, 2024 .
3.Insulet Announces FDA 510(k) Clearance of the Omnipod® 5 App for iPhone . https://investors.insulet.com/news/news-details/2023/Insulet-Announces-FDA-510k-Clearance-of-the-Omnipod-5-App-for-iPhone/default.aspx. Accessed July 15, 2024 .
4.Federal Register . Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Interoperable Automated Glycemic Controller . https://www.federalregister.gov/documents/2022/03/14/2022-05303/medical-devices-clinical-chemistry-and-clinical-toxicology-devices-classification-of-the. Published March 14, 2022. Accessed July 15, 2024 .
5.Food and Drug Administration . FDA Roundup: January 24, 2023 .https://www.fda.gov/news-events/press-announcements/fda-roundup-january-24-2023. Published January 24, 2023. Accessed July 15, 2024 .
6.Sequel’s twiistTM automated insulin delivery system receives FDA 510(k) Clearance . BioSpace . https://www.biospace.com/sequel-s-twiist-automated-insulin-delivery-system-receives-fda-510-k-clearance. Published March 18, 2024. Accessed July 15, 2024 .
7.
Balsam
J.
Re: iLet Dosing Decision Software 510(k) Premarket Notification of Intent to Market the Device . US Food and Drug Administration ; 2023 . https://www.accessdata.fda.gov/cdrh_docs/pdf23/K232224.pdf. Accessed July 15, 2024 .
8.Food and Drug Administration . FDA clears new insulin pump and algorithm-based software to support enhanced automatic insulin delivery . https://www.fda.gov/news-events/press-announcements/fda-clears-new-insulin-pump-and-algorithm-based-software-support-enhanced-automatic-insulin-delivery. Published May 22, 2023. Accessed July 15, 2024 .
9.mylife Loop offers new remote monitoring feature for parents .https://www.ypsomed.com/en/media/details/mylife-loop-offers-new-remote-monitoring-feature-for-parents.html. Published June 7, 2023. Accessed July 15, 2024 .
10.Omnipod® 5 automated insulin delivery system Omnipod . https://www.omnipod.com/what-is-omnipod/omnipod-5?utm_source=google&utm_medium=paid&utm_campaign=prso-aw&utm_content=pmax-brnd&ctoken=7012J000001gYaiQAE&utm_id=21364100800&ad_group_id=&gad_source=1. Accessed July 15, 2024 .
11.
Whooley
SA.
Sequel Med Tech’s Unique Twiist AID System . Drug Delivery Business . https://www.drugdeliverybusiness.com/look-at-sequel-med-tech-twiist/. Published June 22, 2024. Accessed July 22, 2024 .
12.Tandem Diabetes . t:slim X2 Insulin Pump Type 1 diabetes insulin pump tandem diabetes care . https://www.tandemdiabetes.com/products/insulin-pumps/t-slim-x2-insulin-pump. Accessed July 15, 2024 .
13.Tandem secures FDA approval for t:slim X2 insulin pump with Control-IQ . NS Medical Devices . https://www.nsmedicaldevices.com/news/tandem-slim-x2-insulin-pump/.Published December 16, 2019. Accessed July 15, 2024 .
14.Tandem Diabetes Care . Tandem Diabetes Care announces FDA approval and launch of t:slim X2 insulin pump with Dexcom G5 Mobile CGM Integration . https://investor.tandemdiabetes.com/news-releases/news-release-details/tandem-diabetes-care-announces-fda-approval-and-launch-tslim-x2/. Accessed July 15, 2024 .
15.Tandem Diabetes Care . Tandem Diabetes Care launches Tandem Mobi, the world’s smallest, durable automated insulin delivery system . https://investor.tandemdiabetes.com/news-releases/news-release-details/tandem-diabetes-care-launches-tandem-mobi-worlds-smallest/. Accessed July 15, 2024 .
16.US Food and Drug Administration . 510(k) substantial equivalence determination decision summary: CamDiab Ltd . https://www.accessdata.fda.gov/cdrh_docs/reviews/K232603.pdf. Accessed July 22, 2024 .
17.Food and Drug Administration . FDA Roundup: May 24, 2024 . https://www.fda.gov/news-events/press-announcements/fda-roundup-may-24-2024. Published May 24, 2024. Accessed July 22, 2024 .
18.Tidepool loop clearance . https://www.tidepool.org/blog/tidepool-loop-has-received-fda-clearance. Accessed July 22, 2024 .
19.Tidepool loop traditional 510(k) premarket notification, K203689 . US Food and Drug Administration ; 2023 . https://www.accessdata.fda.gov/cdrh_docs/pdf20/K203689.pdf. Accessed July 22, 2024 .
20.Abbott MediaRoom . Tandem Diabetes Care’s t:slim X2TM insulin pump is the first automated insulin delivery system to integrate with Abbott’s New FreeStyle Libre® 2 Plus sensor . https://abbott.mediaroom.com/2024-01-08-Tandem-Diabetes-Cares-t-slim-X2-Insulin-Pump-is-the-First-Automated-Insulin-Delivery-System-to-Integrate-with-Abbotts-New-FreeStyle-Libre-2-Plus-Sensor. Accessed July 22, 2024 .
21.How accurate is my FreeStyle Libre 2 Plus sensor? FAQ .https://www.support.freestyle.abbott/hc/en-us/articles/21906401259665-How-accurate-is-my-FreeStyle-Libre-2-Plus-sensor. Accessed July 22, 2024 .
22.Abbott MediaRoom . U.S.FDA Clears Abbott’s FreeStyle Libre® 2 and FreeStyle Libre® 3 sensors for integration with automated insulin delivery systems . https://abbott.mediaroom.com/2023-03-06-U-S-FDA-Clears-Abbotts-FreeStyle-Libre-R-2-and-FreeStyle-Libre-R-3-Sensors-for-Integration-with-Automated-Insulin-Delivery-Systems. Accessed July 22, 2024 .
23.Business Wire, Inc . Eversense® CGM system receives iCGM designation by the US FDA . https://www.businesswire.com/news/home/20240429218967/en/. Published April 30, 2024. Accessed July 22, 2024 .
24.Dexcom G7 receives FDA clearance: The most accurate continuous glucose monitoring system cleared in the U.S . https://investors.dexcom.com/news/news-details/2022/Dexcom-G7-Receives-FDA-Clearance-The-Most-Accurate-Continuous-Glucose-Monitoring-System-Cleared-in-the-U.S/default.aspx. Accessed July 22, 2024 .
25.FDA-approved insulin pumps used for insulin pump therapy . https://lifesciencesintelligence.com/features/fda-approved-insulin-pumps-used-for-insulin-pump-therapy. Accessed July 15, 2024 .
26.Food and Drug Administration . FDA approves first automated insulin delivery device for type 1 diabetes . https://www.fda.gov/news-events/press-announcements/fda-approves-first-automated-insulin-delivery-device-type-1-diabetes. Published March 24, 2020. Accessed July 15, 2024 .
27.Food and Drug Administration . MiniMed 780G System . https://www.accessdata.fda.gov/cdrh_docs/pdf16/P160017S091B.pdf. Accessed June 25, 2024 .
28.FAQs—MiniMedTM 770G system support medtronic . https://www.medtronicdiabetes.com/customer-support/minimed-770G-system-faqs. Published April 29, 2021. Accessed July 15, 2024 .
29.Integrated Diabetes Services . Medtronic 770G insulin pump pros cons . https://integrateddiabetes.com/medtronic-770g-insulin-pump-pros-and-cons/. Published December 30, 2020. Accessed July 15, 2024 .
30.
Caposino
P.
Re: MiniMed 780G System Premarket Approval Application Supplement . US Food and Drug Administration ; 2021 . https://www.accessdata.fda.gov/cdrh_docs/pdf16/P160017S091A.pdf. Accessed July 15, 2024 .
31.Abbott Enters Global Partnership to Connect Its World-Leading Continuous Glucose Monitoring System with Medtronic’s Insulin Delivery Devices . Abbott. https://abbott.mediaroom.com/2024-08-07-Abbott-Enters-Global-Partnership-to-Connect-Its-World-Leading-Continuous-Glucose-Monitoring-System-with-Medtronics-Insulin-Delivery-Devices. August 7, 2024. Accessed August 26, 2024 .
32.Medtronic announces FDA approval of SimpleraTM CGM and global partnership with Abbott . Medtronic News. https://news.medtronic.com/2024-08-07-Medtronic-announces-FDA-approval-of-Simplera-TM-CGM-and-global-partnership-with-Abbott. August 7, 2024. Accessed August 26, 2024 .
33.Food and Drug Administration . Center for Devices and Radiological Health . Premarket Notification 510(k). https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/premarket-notification-510k. Published December 5, 2023. Accessed July 15, 2024 .
34.
Braune
K
Lal
RA
Petruželková
L
, et al . Open-source automated insulin delivery: International consensus statement and practical guidance for health-care professionals . Lancet Diabetes Endocrinol . 2022 ;10 (1 ):58 -74 . doi:10.1016/S2213-8587(21)00267-9 .
35.IEEE SA . IEEE Medical Device Cybersecurity Certification Program .https://standards.ieee.org/products-programs/icap/programs/medical-devices-cybersecurity/. Accessed July 15, 2024
36.Omnipod® 5 Automated Insulin Delivery System is now FDA-cleared for People with Type 2 Diabetes . Insulet. https://investors.insulet.com/news/news-details/2024/Omnipod-5-Automated-Insulin-Delivery-System-is-now-FDA-cleared-for-People-with-Type-2-Diabetes/default.aspx. August 26, 2024. Accessed August 26, 2024 .