Roche today gave a presentation debuting its first continuous glucose monitor (CGM) offering that utilizes predictive AI. The company unveiled its Accu-Chek SmartGuide in an event at the Advanced Technologies & Treatments for Diabetes (ATTD) conference in Florence, Italy. It remains an investigational device not yet authorized for sale. Julien Boisdron, Roche Diabetes Care’s chief medical […]
Drug-Device Combinations
Smiths Medical recall affects nearly 86,000 syringe pumps with software issues
Smiths Medical issued a recall for its Medfusion Model 3500 syringe pump due to issues associated with earlier software versions. The ICU Medical unit issued the recall as a correction — not a product removal. It affects 85,961 pumps distributed between Aug. 9, 2022, and Aug. 15, 2023. Smiths Medical initiated the infusion syringe pump […]
Real-world data backs Abbott FreeStyle Libre CGM in tandem with GLP-1s
Abbott today announced data from two real-world studies highlighting the success of its CGM when used with GLP-1 drugs. Data showed that people with type 2 diabetes using GLP-1s with FreeStyle Libre had a greater improvement in HbA1c compared to GLP-1s alone. Abbott presented the findings at the Advanced Technologies & Treatments for Diabetes (ATTD) […]
Tandem Diabetes Care prices $275M offering
Tandem Diabetes Care (Nasdaq:TNDM) announced today that it priced an offering of convertible senior notes worth $275 million. The San Diego-based automated insulin delivery technology developer plans to sell the notes, due 2029, to qualified institutional buyers. It upsized the offering from the previously announced $250 million aggregate principal amount. The company also offered initial […]
FDA clears first over-the-counter CGM from Dexcom
Dexcom announced today that the FDA cleared its Stelo glucose biosensor that does not require a prescription. This marks the first FDA clearance for a continuous glucose monitoring (CGM) technology for over-the-counter use. In January, Dexcom first announced that it submitted the new Stelo sensor to the FDA for review at the end of last […]
Dexcom announces direct-to-watch feature for G7 CGM, strong automated insulin delivery outcomes
Dexcom announced today that it introduced a direct-to-Apple-Watch feature for its G7 continuous glucose monitor (CGM) users. The company plans a phased launch for all G7 iOS users everywhere by the end of the second quarter of this year. This means G7 soon becomes the only CGM system that can connect directly to Apple Watch […]
Vivani prices $15M offering to support long-term drug delivery implant
Vivani Medical (Nasdaq:VANI) announced today that it entered into a securities purchase agreement worth $15 million in proceeds. The company entered the agreement with an institutional investor. It covers the purchase of just shy of 4 million shares of common stock and warrants to purchase common stock. Alameda, California-based Vivani priced the shares at $3.80 […]
FDA approves Boston Scientific’s Agent drug-coated balloon
Boston Scientific announced today that it received FDA approval for its Agent drug-coated balloon (DCB). The DCB won approval for treating coronary in-stent restenosis (ISR) in patients with coronary artery disease. ISR occurs when plaque or scar tissue obstructs or narrows a stented vessel. Marlborough, Massachusetts–based Boston Scientific plans a U.S. launch for Agent in […]
Report: Insulet trumps Medtrum again in French patent spat
JUVE-Patent reports that the Judicial Court of Paris again ruled in favor of Insulet in its patent battle with Medtrum. According to the report, the court sided with Insulet in a case regarding the company’s patent (EP 1 874 390). The ruling finds that Medtrum’s A6 and A7+ TouchCare insulin pump devices infringe the valid Insulet […]
These diabetes devices are set to launch in 2024
The diabetes space continues to innovate, and it doesn’t look like that’s stopping any time soon, with 2024 set to be another banner year. At the end of 2023, we compiled a list of the 10 biggest diabetes technology stories of the year. Some of those stories didn’t end in 2023, though, as a few […]
Irish startup Gasgon Medical looks to raise $4.3M for IV delivery tech
Gasgon Medical reportedly hopes to raise more than $4.3 million (€4 million) to support its technology for fast, accurate IV delivery. The Cork, Ireland-based medtech startup already has commitments from returning lead investors, according to The Business Post. Founded in 2018, Gasgon develops a medical device that assists healthcare providers in IV (intravenous) administration delivery. The […]