Better Therapeutics (Nasdaq:BTTX) announced today that it submitted a de novo classification request to the FDA for its BT-001 technology. San Francisco-based Better Therapeutics seeks marketing authorization for the BT-001 prescription digital therapeutic (PDT). It potentially represents the first-in-class PDT using cognitive behavioral therapy (CBT) to treat type 2 diabetes. Marketing initially would cover type […]
JDRF launches Type 1 Diabetes Index simulation tool
JDRF announced today that it launched the Type 1 Diabetes Index (T1D Index) data simulation tool for measuring the impact of T1D around the globe. The tool measures the human and public health impact type 1 diabetes has in every country. JDRF said it addresses wide gaps in data about the incidence and impact of […]
FDA approves Medtronic drug-eluting stents for treating bifurcation lesions
Medtronic (NYSE:MDT) announced today that the FDA approved its Onyx drug-eluting stents (DES) for treating certain lesions. Approval covers the treatment of non-left main bifurcation lesions utilizing the provisional bifurcation stenting technique. The technique uses a single stent to treat the bifurcation in percutaneous coronary interventions (PCIs). It applies to the FDA-approved and CE-marked Onyx […]
Study backs automated insulin delivery system from Diabeloop
Diabeloop today announced 12-month data supporting its hybrid closed-loop DBLG1 automated insulin delivery system. Paris-based Diabeloop evaluated DBLG1 in a large, multi-country patient cohort. Results demonstrated constant improvement in time in range and time in hypoglycemia remaining significantly low. The company said in a news release that the results, combined with trust in its algorithm, […]
Medtronic, FDA warn on potential cybersecurity risk with MiniMed insulin pump
Medtronic (NYSE:MDT) issued an urgent medical device correction notice to warn of potential issues with some MiniMed automated insulin delivery systems. The notice — dated this month — covers the company’s MiniMed 600 series insulin pumps (MiniMed 630G and 670G). Affected devices also include the Guardian Link 3 transmitter, Contour Next Link 2.4 blood glucose […]
Vaxxas receives more than $5 million grant for vaccine delivery patch
Vaxxas announced today the Australian government is granting it nearly $5.5 million for the manufacturing of its vaccine delivery device. Cambridge, Massachusetts-based Vaxxas picked up AU$8.2 million ($5.48 million). The second-round grant represents part of the Australian government’s Modern Manufacturing Initiative (MMI). Funding supports the manufacturing scale-up of Vaxxas’ device for applying vaccines to the […]
Study says Abbott FreeStyle Libre reduces rate of hospitalization
Abbott (NYSE:ABT) today announce real-world data demonstrating reductions in hospitalizations associated with the FreeStyle Libre system. The RELIEF study evaluated Abbott’s FreeStyle Libre continuous glucose monitoring (CGM). The findings included the significant reduction of the rate of hospitalizations due to acute diabetes events (ADEs). This study evaluated people living with type 2 diabetes on once-daily […]
Insulet wins CE Mark for Omnipod 5 for children 2 and up
Insulet (Nasdaq:PODD) announced today that it received CE mark approval in Europe for its Omnipod 5 automated insulin delivery system. Insulet can now market Omnipod 5 in Europe for individuals 2 years and older with type 1 diabetes. Acton, Massachusetts-based Insulet said it represents the first CE-marked tubeless hybrid closed loop system. The latest-generation Omnipod 5 […]
Advanced NanoTherapies wins FDA breakthrough nod for drug-coated balloon
Advanced NanoTherapies announced today that it received FDA breakthrough device designation for its SirPlux Duo drug-coated balloon (DCB). Los Gatos, California-based Advanced NanoTherapies received the breakthrough nod for the use of the DCB in treating coronary artery disease in vessels less than 3.0mm. The regulatory win comes weeks after two previous breakthrough designations. SirPlux Duo […]
Recall of Baxter Clearlink due to risk of leaks is Class I
The FDA announced today that the recall of the Clearlink basic solution set with Duovent from Baxter (NYSE:BAX) is Class I, the most serious kind. Clearkink with Duovent is part of a system for administering drugs and solutions to patients. Health providers use the majority of the sets to deliver hazardous drugs, such as chemotherapy […]
