In another boost to its diabetes portfolio, Medtronic plc was granted CE mark approval for its Simplera continuous glucose monitor (CGM) sensor. The EU greenlight for Simplera follows the U.S. FDA approval for Medronic’s Minimed 780G insulin pump system earlier in the year. Simplera is an all-in-one disposable CGM sensor which features a two-step insertion process and will help patients who must have multiple daily injections (MDI) manage their diabetes.

Two tough years have taken a toll on Medtronic plc with a warning letter for its diabetes unit, a reorganization that will spin off its respiratory, patient care and renal groups and layoffs of an undisclosed number of employees that began last week. The announcement late Friday of the U.S. FDA approval of the Minimed 780G insulin pump system could be a turning point for the company that brings it back into the competition for the growing diabetes market.

An artificial pancreas system that draws on research conducted at the University of Virginia to effectively combine Dexcom Inc.’s continuous glucose monitor and Tandem Diabetes Care Inc.’s artificial intelligence-enabled insulin pump works effectively in children under 6 years of age with type 1 diabetes, a study published in the New England Journal of Medicine showed.

Insulet Corp. reported much better than expected fourth quarter results, following on Dexcom Inc.’s report of earlier than expected coverage decision from CMS for its just-approved G7 continuous glucose monitor. Insulet (NASDAQ:PODD) soundly beat Wall Street’s expectations for quarterly revenue by $38 million, bringing in $332 million instead of the anticipated $332 million, driven by strong uptake of its Omnipod tubeless insulin pump.

Tandem Diabetes Care Inc. entered a definitive agreement to acquire AMF Medical SA for CHF 62.4 million (US$67.1 million) in cash at closing plus future payments of as much as CHF 129.6 million (US$139.43 million) contingent on meeting certain milestones. Tandem also invested CHF 8 million (US$8.6 million) in AMF in the third quarter of 2022. The transaction is expected to close in January 2023.

Medtronic plc’s new Extended infusion set shows the advantages of tending to details. Tubing doesn’t get much respect, but the changes Medtronic made to its set will substantially reduce the burden of disease management for patients with diabetes who use insulin pumps. The Medtronic Extended infusion set can be used for up to seven days, more than doubling the time between changes. The changes also sharply reduced insulin loss, resulting in a 25% reduction in waste of the increasingly expensive medication.

The U.S. FDA posted notice recently regarding a vulnerability seen in the Minimed 600 series of insulin pumps made by Dublin-based Medtronic plc, which exposes the user to the risk of unauthorized access to the pump’s software. The vulnerability could be exploited to interfere with the system’s ability to deliver only the desired amount of insulin, although the FDA acknowledged that no adverse events or complaints have been reported.

The FDA reported two class I recalls associated with insulin pumps made by Dublin-based Medtronic plc, albeit for two significantly different issues. The two recalls affect roughly 495,000 units combined, and may significantly affect access to some patients. One of the recalls was for Minimed 600 series insulin pumps, a recall announced in 2019 and expanded in October. The recall addresses the risk of incorrect dosing of insulin due to a faulty clear retainer ring, which is used to lock the insulin cartridge into place in the insulin pump reservoir. The second recall is for remote controllers used with Medtronic insulin pumps. In this instance, the action was undertaken due to cybersecurity concerns, although the controllers in question are no longer in distribution.

Abbott Laboratories and Tandem Diabetes Care Inc. have finalized an agreement related to integrated diabetes solutions. Specifically, the duo is planning to combine Abbott's Freestyle Libre continuous glucose monitoring (CGM) technology with San Diego-based Tandem's insulin delivery systems, with an eye toward providing more options for diabetes management.

Royalty deals by an investor into a particular pharmaceutical company program are not unheard of. This structure allows the investor to secure a portion of that specific anticipated upside, while enabling the pharma to fully fund R&D for that program without having to sacrifice other priorities to do so.