The U.S. Food and Drug Administration approved the first adjuvanted pandemic influenza vaccine, Q-pan, to protect against H5N1 influenza, or avian flu. The vaccine, manufactured by GlaxoSmithKline, was developed in partnership with the ...
The Direxion Torqueable Microcatheter-a microcatheter for shrinking tumors or blocking aneurysms-has won FDA and CE Mark approval, Boston Scientific recently announced. The FDA granted the Direxion a 510(k) clearance because it retains ...
Tags: Boston Scientific Microcatheter, FDA Approval, Direxion a 510(k)
The RNS device receiced FDA approval via the PMA pathway. NeuroPace (Mountain View, CA) landed FDA PMA approval for its RNS Stimulator, a device that can detect and treat patients suffering from drug-resistant epilepsy. Seizures occur ...
Tags: RNS, FDA approval, PMA pathway, NeuroPace
Let's say a large medical device company has developed a new computer heart simulator that the FDA thinks is acceptable for running tests--or a new clinical trial design in a cutting-edge field. In the past, a small, early-stage company ...
Tags: Big Medtechs, public-private Medical Device Innovation Consortium, FDA
For many suffering from blindness, the perfect Christmas gift has arrived. Next month, the Argus II Retinal Prothesis System by Second Sight is slated to go on sale in the United States. The Argus II by Second Sight can restore sight for ...
Tags: Bionic Eye, blindness
A biomedical engineer is developing a clinical-grade open-source 12-lead ECG. The device includes support for Android devices and is designed to meet all relevant medical device manufacturing standards, like ISO 60601-1. According to early ...
The Sorin Group recently announced CE Mark approval of its Solo Smart stentless aortic valve, which Milan, Italy-based Sorin is touting as an improvement on its Freedom Solo valve that has been used in Europe since 2004. So how did Sorin ...
Tags: Sorin Group, Solo Smart Valve
Continental Tire's 250 Sumter employees stand behind the plant's first sellable tire. Continental Tire the Americas LLC’s (CTA) new manufacturing facility in Sumter, South Carolina, has received approval from central headquarters in ...
The Gazprom Management Committee Chairman Alexey Miller held at the Company's headquarters a meeting dedicated to the Vladivostok-LNG project. It was noted that the project was progressing rapidly and on schedule – the first train ...
Tags: Metallurgy, Mineral, Energy, gas
A landmark industrial development site in one of Australia’s premier distribution locations has come on the market, with the purchaser able to benefit from the leasing income whilst obtaining masterplan approval to develop the site. ...
Tags: Landmark, Sydney, industrial, site, market
The National Transport Commission is encouraging members of the heavy vehicle industry to register to attend upcoming public consultation forums on draft options for new heavy vehicle charges to apply from 1 July 2014. “Following ...
Tags: registration, open, heavy, vehicle, public, consultation, forum
Kinetic Concepts (KCI) has obtained the US Food and Drug Administration (FDA) approval for its next generation V.A.C.Via negative pressure wound therapy system. The V.A.C.Via therapy system is a single-patient-use, ultra-portable V.A.C. ...
Tags: Therapy System, Medicine
GlaxoSmithKline (GSK) and Amicus Therapeutics have announced that Amicus has received global rights for the global drug development, regulatory and commercial activities of migalastat HCl as a monotherapy and in combination with enzyme ...
Tags: GlaxoSmithKline, Fabry Agreement
Pfizer has secured regular approval from the US Food and Drug Administration (FDA) for its Xalkori (crizotinib) capsules to treat patients with metastatic ALK-positive non-small cell lung cancer (NSCLC). The approval was based on ...
AtriCure, a developer of solutions to treat atrial fibrillation (Afib), has announced the US Food and Drug Administration’s (FDA) approval to begin enrollment in a clinical study of its AtriClip left atrial appendage exclusion system. ...
Tags: AtriCure, Stroke Prevention