US-based BioMarin Pharmaceutical has announced that the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) of the US Food and Drug Administration (FDA) voted in favor of approval of Vimizim for the treatment of Morquio A ...
Germany-based Bayer HealthCare and US-based Onyx Pharmaceuticals have announced that the US Food and Drug Administration (FDA) has approved Nexavar (sorafenib), an oral multi-kinase inhibitor, for the treatment of patients with ...
According to federal officials, the budget sequester and the government shutdown have drained approximately $85 million from the FDA's financial reserves. These reserves came from user fees that pharmaceutical and medical device companies ...
Scanadu-a Silicon Valley-based startup seeking to commercialize a real-life version of a Star Trek tricorder- has recently raised $10.5 million in a Series A venture capital round, the company said Tuesday. The company is among the nearly ...
Tags: Scanadu, Tricorder Technology, Venture Capital Cash, Star Trek tricorder
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 ...
Covalon Technologies, an advanced medical technologies company, will showcase new wound healing and infection management products at MEDICA medical technology trade fair, 20 November to 23 November in Dusseldorf, Germany. The latest ...
Tags: Covalon, Wound Healing Products
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
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
Fenwal, a Fresenius Kabi company, has received the US Food and Drug Administration (FDA) 510(k) clearance for the Alyx system software version 3.1. The new software gives the Alyx system a protocol for closed system plasma collection and ...