May 20, 2019
On Friday, the FDA issued a warning to patients and providers describing the dangers of diabetes management devices and software that haven’t been assessed by the agency. These include any unapproved or unauthorized continuous glucose monitors, insulin pumps and automated insulin dosing systems, whether used as a standalone device or integrated as part of a glucose management system.
February 19, 2019
Last week the FDA granted its first marketing authorization to an interoperable insulin pump that is compatible with automated insulin dosing systems, continuous glucose monitors, blood glucose meters and other diabetes therapy devices built by different manufacturers.
The Tandem Diabetes Care t:Slim X2 insulin pump was reviewed through the De Novo premarket review pathway, making it the first of...
November 7, 2018
Editor's note: The headline and body of this article has been edited to clarify that Samsung's integration with the Omnipod Dash have not yet been implemented.
Samsung Galaxy smartphones will be serving as the controlling device for Billerica, Massachusetts-based Insulet Corporation’s tubeless insulin pump devices, the two companies announced today.
Insulet’s recently FDA-cleared Omnipod Dash...
July 17, 2018
As Johnson & Johnson continues to move out of the diabetes business, the company has sold its Calibra product (marketed as OneTouch Via, but never launched) to CeQur, a 10-year-old company working on a similar insulin-delivery wearable. Terms of the deal were not disclosed, but CeQur has acquired an exclusive worldwide license for the technology.
“They’re divesting out of the diabetes market...
July 11, 2018
In 2016, UnitedHealthcare and Medtronic cut a deal that established the latter’s devices as the preferred insulin pumps for United members with diabetes. Now, the companies have announced year one data suggesting that members who took advantage of the companies’ arrangement experienced fewer preventable hospital admissions when compared to members relying on multiple daily injections of insulin...
June 25, 2018
This weekend saw the kickoff of the American Diabetes Association’s 78th annual conference, and with it a slew of new data from diabetes management players. The meeting included presentation on studies covering a range of technologies, such as continuous glucose monitors, insulin pumps, apps, and other digital-backed management strategies.
Among the studies highlighted by the association was an...
August 15, 2017
Touchscreen insulin pump maker Tandem Diabetes announced a new clinical trial for an insulin pump with a predictive low glucose suspend (PLGS) algorithm. Another step on the road to an artificial pancreas, PLGS allows Tandem to automatically suspend insulin delivery when it predicts low glucose and resume it when glucose starts to rise again.
“The start of this pivotal trial is another important...
October 4, 2016
Following prompting from security and IT firm Rapid7, Johnson & Johnson, through its subsidiary Animas, has reached out to users of the Animas OneTouch Ping Insulin Infusion Pump to inform them about security vulnerabilities and how to mitigate them. According to Rapid7, because the communication with the insulin pump is not encrypted, an attacker could theoretically trigger unauthorized...
September 29, 2015
Medtronic has launched its MiniMed Connect system, which allows people with diabetes who use both a Medtronic continuous glucose monitor (CGM) and a Medtronic insulin pump to see data from both device on their smartphone, and send it to their caregiver.
"It’s part of our plan to become a holistic diabetes management company," Annette Brüls, President of the Diabetes Service and Solutions business...
June 5, 2015
Medtronic has received FDA 510(k) clearance for its MiniMed Connect device, which allows users of Medtronic's continuous glucose monitor (CGM) and insulin pump to view data from those devices on their smartphone. At the same time, Medtronic announced a partnership with Samsung to optimize the viewing of this CGM and pump data.
The MiniMed Connect device is a keychain-sized device that users of...