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 (NYSE:ABT) 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 […]
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 (Nasdaq:DXCM) 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 (Nasdaq:DXCM) 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 […]
Know Labs to raise up to $12M for non-invasive CGM tech
Know Labs (NYSE:KNW) announced that it entered into a funding agreement for an investment worth up to $12 million. The Seattle-based company executed a $4 million close as part of this investment with Lind Global Fund II. The Lind Partners, a New York-based institutional fund manager, manages Lind Global Fund II. Funding helps Know Labs […]
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 [WtwhTicker symbol=”BSX”](NYSE: BSX)[/WtwhTicker] 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 […]
FDA submission for 365-day CGM from Senseonics is ‘imminent’
Senseonics (NYSE:SENS) shares dipped after hours on fourth-quarter results that came in ahead of the consensus forecast. The company also reported an “imminent” submission of its latest, longest-lasting continuous glucose monitoring (CGM) technology. Shares of SENS fell 3.5% to 69¢ apiece after the market closed today. MassDevice’s MedTech 100 Index — which includes stocks of […]
Vivani has positive data for long-term drug-eluting weight loss implant as it shifts strategy
Vivani Medical (Nasdaq:VANI) today announced positive pre-clinical data on weight loss effects for its long-term exenatide implant. Alameda, California-based Vivani has its miniature, twice-yearly exenatide implant — NPM-115 — under development to treat chronic weight management. The company also disclosed that it included semaglutide as the active pharmaceutical ingredient in its NPM-139 subdermal GLP-1 implant […]