Emergent BioSolutions (NSYE:EBS) announced today that it appointed Joseph C. Papa as its new president and CEO. Papa’s appointment to the corner office of the Gaithersburg, Maryland-based company went into effect today. He succeeds Haywood Miller, who stepped down from his role as interim CEO today as well. Emergent BioSolutions is known for its Narcan […]
Drug-Device Combinations
ICU Medical’s Smiths Medical has a major syringe pump recall
The FDA this week said it’s designated an ICU Medical and Smiths Medical recall of Medfusion syringe pumps as Class I, the agency’s most serious level of medical device recall. The recall involves more than 50,000 Medfusion Model 4000 syringe infusion pumps in the U.S. that were distributed from Nov. 16, 2010, to July 28, […]
Enable Injections to expand manufacturing facility to support drug delivery device production
Enable Injections announced today that it plans to expand its manufacturing operations with a new, large-scale facility in Ohio. In addition to the expansion in Springdale, Ohio, the company plans to enhance its corporate headquarters in Evendale, Ohio. Both facilities, nearby one another, sit just outside of Cincinnati. Enable Injections plans for its new 90,000-square-foot […]
Tandem Diabetes Care launches Mobi mini automated insulin patch pump
Tandem Diabetes Care (Nasdaq:TNDM) announced today that it kicked off the U.S. commercial launch of its Mobi insulin patch pump. The San Diego-based company says Mobi, which is fully controllable from a mobile app, is the world’s smallest durable automated insulin delivery (AID) system. It received FDA clearance for people with diabetes ages six and […]
Embecta beats The Street in Q1, raises guidance as insulin pump development moves along
Embecta (Nasdaq:EMBC) shares took a hit this morning despite Street-beating first-quarter results and increased 2024 guidance. Shares of EMBC fell 7.8% at $16.37 apiece as the market opened today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — opened today relatively even. The Parsippany, New Jersey-based BD Diabetes […]
Dexcom says revenues could grow 20% in 2024
Dexcom (Nasdaq:DXCM) shares dipped after hours on fourth-quarter results that came in ahead of the consensus forecast. Shares of DXCM fell 1.6% at $125 apiece after the market closed today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — closed the day up 0.2%. The San Diego-based continuous […]
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 […]
Enable Injections promotes COO from within
Wearable drug delivery technology maker Enable Injections announced today that it named David Kroekel as its new COO. Cincinnati-based Enable develops the enFuse platform, whichallows hands-free, hidden needle drug delivery of up to 25 mL. Its simple design enables flexibility for at-home self-administration or in-clinic use. The FDA cleared the system for the delivery of […]
Insulet integrates Abbott FreeStyle Libre 2 Plus, Omnipod 5 in Europe
Insulet (Nasdaq:PODD) announced today that it received CE mark approval for the integration of the Abbott (NYSE:ABT) FreeStyle Libre 2 Plus with Omnipod 5. European approval covers the compatibility of Abbott’s glucose sensor with the Insulet automated insulin delivery system for individuals aged two years and older with type 1 diabetes. Currently, Omnipod 5 works […]
Dexcom launches new ONE+ CGM system in Europe
Dexcom (Nasdaq:DXCM) announced today that it launched its latest continuous glucose monitor (CGM) system, the Dexcom ONE+. The San Diego-based company began rolling out the system in Spain, Belgium and Poland. It plans for a launch next week in the Netherlands, too. In some countries, the system replaces the previous-generation Dexcom One sensor. ONE+ uses […]