The US-based CAS Medical Systems (CASMED) has received the US Food and Drug Administration (FDA) 510(k) approval for its next-generation Fore-Sight Elite Absolute Tissue Oximeter. The Fore-Sight ELITE Oximeter, which is capable of ...
Tags: Casmed, Absolute Tissue Oximeter
Prime Food USA is recalling Latis brand Herring Fillet 'Matiej', Salmon Fillet Slices and Herring Fillet 'Forelka' in oil due to listeria monocytogenes contamination, according to the US Food and Drug Administration (FDA). The products ...
Tags: Prime Food, Listeria Contamination
The US Food and Drug Administration (FDA) has issued a complete response letter (CRL) to Allergan's New Drug Application (NDA) for Levadex (dihydroergotamine) inhalation aerosol for the acute treatment of migraine in adults. In addition ...
Tags: Migraine Therapy, Medicine
BioFire Diagnostics has submitted 510(k) Application to the US Food and Drug Administration (FDA) for its FilmArray Blood Culture Identification (BCID) Panel. The BCID panel provides automatic results for the most common infectious causes ...
Tags: Biofire, Filmarray Blood Culture
The US Food and Drug Administration (FDA) has granted 510(k) clearance to Carticept Medical's new computer-controlled injection system. The new Navigator Delivery System (DS) is designed to increase the efficiency, comfort, safety and ...
The US Food and Drug Administration (FDA) has granted 510(k) clearance to Teleflex's ISO-Gard Mask with ClearAir technology. The ISO-Gard Mask is designed to reduce waste anesthetic gas (WAG), exhaled by the patients who are recovering in ...
Tags: FDA, Drug, Anesthetic Gas
The US Food and Drug Administration (FDA) has cleared Sophono's Alpha 2 magnetic implant system for use with magnetic resonance imaging (MRI). The clearance allows US patients implanted with Sophono Alpha 2 abutment-free, bone conduction ...
Tags: FDA, Drug, magnetic implant system
Olympus has gained 510(k) clearance from the US Food and Drug Administration (FDA) for its Articulating HD 3D laparoscopic surgical video system. The system, ENDOEYE FLEX 3D, when compared with conventional 2D surgical systems reduces ...
Tags: Olympus, FDA Nod, Flex 3D System
The US Food and Drug Administration (FDA) has granted 510(k) clearance to Monteris Medical's NeuroBlate system for the treatment of brain tumors and other lesions. The MRI system embedded in the device provides visualization and allows ...
The US Food and Drug Administration (FDA) has granted 510(k) clearance to Terumo BCT's automated blood collection system, designed for collecting and storing platelets in Isoplate platelet additive solution (PAS). The solution, which ...
The US Food and Drug Administration (FDA) has announced that it is requesting a budget of $4.7bn in 2014, which includes about $295.8m to strengthen food safety. The agency noted that the user fees would fund 94% of the proposed budget ...
Tags: FDA, Food Safety
Agilent Technologies' company, Dako, has announced that US Food and Drug Administration (FDA) has given consent to sell its Clone EP1 diagnostic tool for breast cancer treatment in the US market. The antibody, called FLEX Monoclonal ...
GlaxoSmithKline (GSK) has received the marketing authorization from Germany's Paul Ehrlich Institut (PEI) and the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK for its quadrivalent (four-strain) influenza vaccine. ...
Tags: GSK, Strain Influenza Vaccine
The US Food and Drug Administration (FDA) has granted 510(k) approval to CryoLife's new Hemodialysis Reliable Outflow (HeRO) device. The device, which the company claims, is the only subcutaneous AV access solution that maintains ...
The US Food and Drug Administration (FDA) has cleared Hitachi Medical Systems America's new SCENARIA scalable CT platform. The new SCENARIA Advanced 128 CT system, which combines the latest dose saving and imaging technologies, ...
Tags: FDA, Hitachi Medical, Medicine