Abbott executive Dr. Nick West believes the company offers the “best-in-class” drug-eluting stent with its Xience platform. When Abbott (NYSE:ABT) CMO & divisional VP of global medical affairs for its vascular business Dr. Nick West looks back at his use of drug-eluting stents in the early 2000s, all he sees now is innovation. As a practicing interventional cardiologist, West […]
FDA
BD begins remediation in Alaris infusion system software recall
BD (NYSE:BDX) announced today that it will begin remediation for a 2020 Class I-level recall of its Alaris infusion system. Franklin Lakes, N.J.–based BD has had shipments of Alaris pumps on hold after the FDA called for a comprehensive 510(k) submission to cover a host of software fixes, with pumps only going to health providers […]
FDA warns on increased risk of death with Pepaxto for multiple myeloma
The FDA today issued a notice warning patients and healthcare professionals of a potentially increased risk of death with Pepaxto. Pepaxto (melphalan flufenamide), used with dexamethasone to treat patients with multiple myeloma, demonstrated an increased risk of death in the OCEAN clinical trial. The FDA required that the manufacturer, Boston-based Oncopeptides (STO:ONCO) suspend enrollment for […]
FDA approves Nevro spinal cord stimulation to treat chronic pain with diabetic neuropathy
Nevro (NYSE:NVRO) announced today that it received FDA approval for its Senza system for treating chronic pain associated with PDN. Redwood City, Calif.-based Nevro’s Senza system’s approval is specific to Nevro’s 10 kHz stimulation, with the company touting that it now has the only spinal cord stimulation system approved by the FDA with a specific indication […]
FDA clears Dexcom Partner Web APIs
Dexcom (NSDQ:DXCM) announced today that it received FDA clearance for its Dexcom Partner Web application programming interfaces (APIs). The San Diego-based company’s Dexcom Partner Web APIs enable invited third-party developers to integrate real-time continuous glucose monitoring (CGM) data into their digital health apps and devices. Dexcom’s CGM data can be integrated into third-party apps and […]
FDA grants iStar Medical IDE for glaucoma implant pivotal trial
iSTAR Medical announced today that the FDA granted investigational device exemption to start a pivotal trial with its MINIject implant. Wavre, Belgium–based iStar’s MINIject minimally invasive implant for glaucoma surgery will be investigated in the STAR-V study, enrolling over 350 patients with primary open-angle glaucoma. MINIject combines the porous structure of iSTAR’s proprietary STAR material […]
Teva initiates U.S. recall of Topotecan metastatic ovarian cancer injection treatment
Teva Pharmaceuticals (NYSE:TEVA) initiated a voluntary recall of a lot of its Topotecan injection 4mg/4mL (1mg/mL) in the U.S. The voluntary recall came as a result of a complaint received from a pharmacy after a single glass particle was observed inside one vial. Following further examination of the complaint sample, two other particulates were found […]
Bionaut Labs receives orphan drug designation for its lead therapeutic
FDA has granted orphan drug designation to the drug-device startup Bionaut Labs (Los Angeles) for the company’s lead therapeutic program, BNL-101, for the local treatment of malignant gliomas. BNL-101 is a drug-device combination that brings together remote-controllable microscale robotics and the chemotherapy agent doxorubicin. In March, the startup received $20 million in funding from Khosla Ventures. […]
Smiths Medical recalls some insulin syringes over skewed graduation marking
Smiths Medical announced today that it issued recall notices for its Jelco Hypodermic Needle-Pro fixed needle insulin syringes. Minneapolis-based Smiths Medical became aware of specific models and lots of the Jelco Hypodermic Needle-Pro fixed needle syringes that may exhibit skewed odd number line graduation markings on their syringe barrels. The company identified markings skewed upward […]
FDA classifies Novo Nordisk insulin pen recalls as Class I
In May, Novo Nordisk announced that it voluntarily recalled 1,468 product samples related to its Levemir, Tresiba, Fiasp, Novolog and Xultophy insulin lines. The products were held at sub-freezing temperatures, prompting the FDA to recently classify the recalls as Class I. FDA uses the Class I designation for situations where there is “a reasonable probability” […]