SonoThera announced that it received exclusive global commercial licensing rights from GE HealthCare (NYSE:GEHC) for two of its microbubble products. South San Francisco-based SonoThera received the rights for the Optison and Sonazoid microbubble products. It uses them in the development of its novel, ultrasound-guided nonviral gene therapy platform. According to SonoThera co-founder and CEO Kenneth […]
Drug-Device Combinations
ICU Medical stock slides on mixed Q4, projected 2023 losses
ICU Medical (Nasdaq:ICUI) shares took a hit today on fourth-quarter results that came in mixed compared to the consensus forecast. Shares of ICUI fell 6.2% at $166.70 apiece just after the market opened today. The San Clemente, California-based company posted losses of $15.5 million in the quarter. That amounts to 65¢ per share on sales […]
Tandem Diabetes Care appoints new board chair
Tandem Diabetes Care (Nasdaq:TNDM) recently announced the appointment of Rebecca Robertson as the chair of its board of directors. Robertson initially joined Tandem’s board as an independent director in January 2019. She succeeds Kim Blickenstaff as chair. Blickenstaff intends to continue as a member of the board. “We’re deeply grateful to Kim for his instrumental […]
Glaukos submits FDA New Drug Application for iDose TR drug-eluting implant
Glaukos (NYSE:GKOS) announced today that it submitted a New Drug Application (NDA) to the FDA for its iDose TR implant. Aliso Viejo, California-based Glaukos designed iDose TR as a micro-invasive intraocular implant. It continuously delivers therapeutic levels of a proprietary formulation of travoprost from within the eye over extended periods of time. Once all travoprost […]
iRadimed issues urgent field safety notice for some infusion pump syringe adapters
iRadimed (Nasadq:IRMD) issued an urgent medical device correction letter to warn of issues with some infusion pump syringe adapter sets. The letter notifies customers of a potential issue with some 1057 Syringe Adapter Sets. The issue relates to the syringe venting function during use. This can lead to reduced flow with the MRidium infusion pump, […]
Study backs Medtronic next-gen MiniMed 780G insulin pump for type 1 diabetes
Medtronic (NYSE:MDT) announced today that one-year data backs the use of its next-generation MiniMed 780G automated insulin pump. The ADAPT study compared MiniMed 780 G against multiple daily injections of insulin with an intermittently scanned CGM. ADAPT, which included 82 subjects, marks the first multi-national, randomized controlled study comparing these methods. The study evaluated adults […]
Insulet stock rises on Street-beating Q4, expected Omnipod growth
Insulet (Nasdaq:PODD) shares ticked up today — a day after releasing fourth-quarter results that came in well ahead of the consensus forecast. Shares of PODD were up slightly to $299.29 apiece by midday trading today. The Acton, Massachusetts-based automated insulin technology developer posted profits of $17 million. That amounts to 24¢ per share on sales […]
Glooko, Sanofi partner on insulin pen connectivity
Glooko announced today that it entered into a partnership with Sanofi to integrate a connected device for insulin pens into its digital platform. SoloSmart, a single-piece, add-on connected device works with Sanofi’s SoloStar and DoubleStar insulin injection pens. It records the insulin dose, date and time of injection. Through this partnership, the company’s can offer […]
Tandem Diabetes Care stock down on Q4 misses
Tandem Diabetes Care (Nasdaq:TNDM) shares are down today on fourth-quarter results that came up shy of the consensus forecast. Shares of TNDM were down more than 6% to $37.28 apiece by midday trading today. MassDevice‘s MedTech 100 Index, which includes stocks of the world’s largest medical device companies, was up more than 8%. Yesterday evening, the […]
Innovation Zed wins CE mark for insulin pen add-on device
Innovation Zed announced that it received CE mark approval in Europe for its InsulCheck Dose add-on device. Dublin, Ireland-based Innovation Zed designed the InsulCheck Dose device as a single-unit add-on device for pen injectors. It automatically captures dose value dialed, injection event time stamps and temperature. The device also captures mounting and unmounting events. According […]