Tag: Medtronic
Medtronic seeks FDA clearance for pump
April 24, 2025HME News Staff
GALWAY, Ireland – Medtronic has submitted 510(k) applications to the U.S. Food and Drug Administration seeking clearance for an interoperable pump. FDA clearance of this pump would pave the way for system integration with a continuous glucose monitoring (CGM) sensor based on Abbott's most advanced CGM platform. 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...
In brief: Numotion reports data incident, Abbott launches app
April 23, 2025HME News Staff
PHOENIX - Numotion recently learned that certain employee email accounts were accessed without authorization on several occasions between Sept. 2, 2024, and Nov. 18, 2024, the company said in a Notice of Data Security Incident posted on its website.
In the notice, the company states: “Numotion has no reason to believe that anyone was trying to access personal information in the accounts, and there is no indication that any information has been used for fraud or identity theft....
Medtronic sensor receives FDA clearance
April 22, 2025HME News Staff
GALWAY, Ireland – Medtronic has received clearance from the U.S. Food and Drug Administration for the Simplera Sync sensor for use with the MiniMed 780G system. With this approval, the MiniMed 780G system now offers more flexibility for users of the company's most advanced insulin delivery system featuring Meal Detection technology with both the Guardian 4 sensor and Simplera Sync sensor. The Simplera Sync is a disposable, all-in-one sensor that requires no fingersticks with SmartGuard...
Medtronic’s InPen app gets FDA clearance
November 21, 2024HME News Staff
GALWAY, Ireland - Medtronic has received clearance from the U.S. Food and Drug Administration for its new InPen app featuring missed meal dose detection, paving the way for the launch of its Smart MDI system with the Simplera continuous glucose monitor. With this clearance, the system will be the first in the market to recommend corrections for missed or inaccurate insulin doses, providing real-time, personalized insights for individuals on multiple daily injection therapy, the company says. ...
In brief: Abbott, Medtronic partner & InfuSystem, Smith+Nephew partner
August 9, 2024HME News Staff
ABBOTT PARK, Ill. – Abbott will enter a global partnership with Medtronic to collaborate on an integrated continuous glucose monitoring (CGM) system based on Abbott's FreeStyle Libre technology and Medtronic's automated insulin delivery (AID) and smart insulin pen systems.
The integration of Abbott's CGM sensor with Medtronic's AID algorithms will enable automatic adjustments of insulin to keep glucose in range, the companies say.
"This partnership pairs...
Medtronic CGM gets nod from FDA
August 7, 2024HME News Staff
MINNEAPOLIS – Medtronic’s Simplera continuous glucose monitor (CGM) has received regulatory approval from the U.S. Food and Drug Administration. Simplera, the company's first disposable, all-in-one continuous glucose monitor, is half the size of its previous CGMs. The Medtronic Simplera platform includes the Simplera CGM, which is designed to be used as part of a Smart MDI system with the InPen smart insulin pen; and the Simplera Sync sensor, which is designed to be integrated with...
Abbott, Medtronic partner on diabetes system
August 7, 2024HME News Staff
ABBOTT PARK, Ill. – Abbott will enter a global partnership with Medtronic to collaborate on an integrated continuous glucose monitoring (CGM) system based on Abbott's FreeStyle Libre technology and Medtronic's automated insulin delivery (AID) and smart insulin pen systems.
The integration of Abbott's CGM sensor with Medtronic's AID algorithms will enable automatic adjustments of insulin to keep glucose in range, the companies say.
"This partnership pairs...
In brief: AAHomecare survey, Bigfoot sale, Medtronic lawsuit
September 8, 2023HME News Staff
WASHINGTON – AAHomecare has launched a survey to learn what education topics would be most beneficial to an HME company’s livelihood and operations.
The association will use the results of the survey to help shape a curriculum featuring respected thought leaders from the HME Industry and beyond that addresses pressing concerns.
“In a recent industry survey, nearly 250 HME professionals nationwide shared business pain points revealing critical challenges impacting...
Lawsuit accuses Medtronic of sharing patient data
September 6, 2023HME News Staff
DUBLIN – A lawsuit filed against Medtronic alleges that the company’s insulin delivery devices shared patient data with third parties, including Google, in violation of HIPAA and other industry standards, according to online news reports.
The lawsuit, filed by “A.H.” in U.S. District Court in Central California, alleges that Medtronic and its MiniMed and InPen devices transmit personally identifiable information and protected health information to third parties.
Per...
Medtronic launches more effective infusion set
November 22, 2022HME News Staff
DUBLIN – Medtronic has announced the U.S. launch of its Extended infusion set, which it says is the first and only infusion set labelled for up to seven-day wear. An infusion set is tubing that delivers insulin from a pump to the body and typically requires a set change every two to three days. "When patients first begin using a pump, doctors and other health care providers reinforce the need to change their infusion set every two to three days to limit the risk of infection and other safety...