Industry may still be less than fond of the failure of the term “recall” to distinguish between corrections and market withdrawals, but the class I recall of the Insulet Omnipod 5 app for Android smartphones is a correction of some importance. This recall, one of the first to be announced by the FDA in 2024, addresses a software problem that could lead to overdose of insulin, a potentially lethal problem for which the company has already provided a fix.
Dexcom Inc. achieved the first integrations of an automated insulin delivery system (AID) approved for use in the U.S. with its G7 continuous glucose monitoring (CGM) integrating with Tandem Diabetes Care Inc.’s T2:slim X2, announced on Dec. 6, and integration with the Ilet Bionic Pancreas made by Beta Bionics Inc. revealed on Dec. 7.
One of the largest med-tech deals of 2023 was wiped off the charts when Medtronic plc terminated a $738 million agreement to acquire South Korean wearable insulin patch maker Eoflow Co. Ltd., citing “multiple breaches” under its agreements, on Dec. 6.
In efforts to strengthen cooperation between the U.S. and South Korea’s life sciences sector, industry organizations like Biocom California and KoreaBIO are helping foster cross-border collaboration as Korea looks to ramp up the so-called Bio Economy 2.0. KoreaBIO, which stands for the Korea Biotechnology Industry Organization, in its latest feat welcomed a trade delegation run by the San Diego Regional Economic Development Corp. and the World Trade Center San Diego in November 2023, helping bolster cooperation between companies in Korea and in the San Diego and Tijuana, Mexico, regions.
In efforts to strengthen cooperation between the U.S. and South Korea’s life sciences sector, industry organizations like Biocom California and KoreaBIO are helping foster cross-border collaboration as Korea looks to ramp up the so-called Bio Economy 2.0. KoreaBIO, which stands for the Korea Biotechnology Industry Organization, in its latest feat welcomed a trade delegation run by the San Diego Regional Economic Development Corp. and the World Trade Center San Diego in November 2023, helping bolster cooperation between companies in Korea and in the San Diego and Tijuana, Mexico, regions.
Sibionics Technology Co. Ltd. said it received the CE mark for its continuous glucose monitoring (CGM) system, coined the Sibionics GS1 CGM, helping the company expand its market opportunities beyond China.
U.S. FDA clearance of Mobi pumped up Tandem Diabetes Care Inc. on Tuesday. The miniaturized insulin pump is indicated for individuals with diabetes, aged 6 years and up, with the FDA action boosting Tandem’s share price from $26.41 to $29.20 in morning trading before falling back to $27.12 by the end of the day.
The recently concluded American Diabetes Association’s (ADA) 83rd Scientific Sessions continued to build powerful use cases for continuous glucose monitors in an ever-wider population and to highlight the value of automated insulin delivery (AID) systems that are getting ever-closer to duplicating the function of a natural pancreas. In addition to the news from Medtronic plc and Dexcom Inc. BioWorld covered earlier this week, Abbott Laboratories, Tandem Diabetes Care Inc. and Insulet Corp. also presented bright projections for future performance.
Medtronic plc agreed to acquire Eoflow Co. Ltd., the manufacturer of Eopatch, a tubeless, wearable and fully disposable insulin delivery service, for $738 million. The deal, which is expected to provide a significant boost to Medtronic’s beleaguered diabetes unit, is slated to close in the second half of 2023. The deal announcement coincided with Medtronic’s release of its fourth quarter results for fiscal 2023.
Insulet Corp. once again broke records with a nearly 50% increase in Omnipod revenues in U.S. in the first quarter and a 32% increase in revenue from the tubeless insulin delivery device worldwide. In an unusual move following such positive quarterly results, the company simultaneously announced a major shake-up in the leadership team, with multiple senior members moving to new positions starting July 1. The latest round of musical chairs comes almost exactly a year after the last at the Insulet, when Founder, President and CEO Shacey Petrovic stepped down and Jim Hollingshead assumed the top spot.
