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 […]
FDA
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 […]
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 […]
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 […]
Philip Morris hires two former FDA officials as it pushes ‘smoke-free’ development
Cigarette maker Philip Morris (NYSE:PM) announced today that it appointed two former FDA officials to leadership positions. Dr. Badrul Chowdhury is the company’s new chief life sciences officer for smoke-free products. Dr. Matthew Holman joins as VP of U.S. scientific engagement and regulatory strategy. Both appointments fall in line with the company’s efforts to push […]
FDA clears syringe infusion pump with Dose IQ software from Baxter
Baxter (NYSE:BAX) announced today that the FDA issued 510(k) clearance to its Novum IQ infusion pump with Dose IQ safety software. Deerfield, Illinois-based Baxter designed its new Novum IQ syringe infusion pump (SYR) to deliver small amounts of fluid at low rates. It includes a technologically integrated user experience with enhanced safety features. The system […]
FDA approves ‘first-in-market’ autoinjector for treating prolonged seizures
Rafa Laboratories announced today that it received FDA approval for its 10mg Midazolam autoinjector for treating status epilepticus, or prolonged seizures. Jerusalem-based Rafa developed the autoinjector through cooperation with the U.S. Department of Defense’s (D0D) Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND). Rafa’s Midazolam 10mg autoinjector received FDA indication for […]
FDA clears Insulet Omnipod 5 for children two years and older
Insulet (Nasdaq:PODD) announced today that the FDA cleared its Omnipod 5 for individuals aged two years and older with type 1 diabetes. Acton, Massachusetts-based Insulet’s Omnipod 5 became the first tubeless, wearable automated insulin delivery system cleared for marketing in the U.S. in January. That clearance covered individuals six years of age and older. In June, […]
MedAlliance wins second FDA IDE nod for drug-coated balloon
MedAlliance announced today that received conditional FDA investigational device exemption (IDE) for its Selution SLR system. The FDA IDE nod for the novel sirolimus-eluting balloon allows MedAlliance to initiate a pivotal clinical trial for use of Selution SLR in the treatment of occlusive disease of the superficial femoral artery (SFA). Geneva, Switzerland-based MedAlliance’s second IDE […]
