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 […]
Food & Drug Administration (FDA)
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 […]
Clearside Biomedical prices $15M offering
Clearside Biomedical (Nasdaq:CLSD) announced that it entered into a securities purchase agreement worth proceeds of approximately $15 million. The company agreed with institutional investors and an existing stockholder on the purchase and sale of 11.1 million shares of common stock and warrants. It set the offer price for one share of common stock and warrant […]
Modular Medical submits next-gen insulin pump for FDA clearance
Modular Medical (Nasdaq:MODD) announced today that it submitted its next-generation MODD1 insulin pump to the FDA for 510(k) clearance. San Diego-based Modular Medical develops patented insulin delivery technologies, aiming to improve access to glycemic control. Its founder, Paul DiPerna, previously founded leading insulin pump maker Tandem Diabetes Care. DiPerna invented and designed Tandem’s t:slim pump. […]
Fresenius Kabi has a Class I Ivenix infusion pump recall
The FDA determined that a recall of the Fresenius Kabi Ivenix large-volume infusion pump is Class I, the most serious kind. This recall affects the LVP-0004 model of the Ivenix large-volume pumps. Fresenius Kabi distributed these systems between Oct. 1, 2021, and July 31, 2023. In total, the company recalled 938 devices in the U.S. […]
Dexcom submits new glucose sensor to FDA, expects launch this summer
Dexcom (Nasdaq:DXCM) announced that it submitted its new Stelo glucose sensor to the FDA for review at the end of last year. The continuous glucose monitor (CGM) maker designed Stelo specifically for people with type 2 diabetes who do not use insulin. San Diego-based Dexcom designed Stelo for a 15-day wear with a cash-pay option. […]
Embecta submits insulin patch pump for FDA clearance
Embecta (Nasdaq:EMBC) announced today that it submitted a 510(k) premarket filing to the FDA for its proprietary insulin patch pump. The Parsippany, New Jersey-based BD Diabetes spinoff developed a proprietary, disposable pump for people with type 2 diabetes. The company provided analysts with some details on the makeup of the open-loop system earlier this year. It […]
Insulet has a Class I recall for the Omnipod 5 Android App
The FDA labeled a recall of the Insulet (Nasdaq:PODD) Omnipod 5 App for Android smartphones as Class I, the most serious kind. Insulet’s recall — a correction, not a product removal — affects software versions 1.1-1.2.3 for the Omnipod 5 automated insulin delivery system. It distributed the software between April 20, 2023, and Dec. 20, […]
PharmaSens submits insulin patch pump for FDA approval
PharmaSens announced today that it submitted an application for FDA approval for its Niia Essential insulin patch pump system. FDA submission follows the pump’s recent ISO 13485 certification for the Switzerland-based company. This encompassed the entire process of design, development, manufacturing and distribution for insulin infusion pumps and accessories. Niia Essential, the first of three […]
BD recalls more Alaris pumps due to compatibility issues with Cardinal Health syringes
The FDA determined that another recall of BD (NYSE:BDX) Alaris infusion pumps is Class I, the most serious kind. In the latest Alaris recall, the company cites compatibility issues with Cardinal Health Monoject syringes. The issue mainly relates to changes made to the products by Cardinal Health. It affects more than 1 million total devices. […]
