Dako, a manufacturer of cancer diagnostics solutions, has received approval from the US Food and Drug Administration to market HercepTest and Her2 Fish pharmDx kit as co diagnostics for pertuzumab (Perjeta), a Genentech cancer drug. ...
Tags: Dako, HER2-positive metastatic breast cance, HER2 FISH pharmDx Kit
The US Food and Drug Administration (FDA) has granted 510(k) clearances to Hollywog's new WiTouch and WiTouch Pro wireless remote controlled devices. The WiTouch devices, which incorporates TENS technology, are designed for the ...
Tags: FDA, treatment of back pain, wireless remote controlled device
ADA Medikal has entered into an agreement to distribute BSD Medical's MicroThermX Microwave Ablation line of products in the Turkish market. The mobile MicroThermX system includes a microwave generator, single-patient-use disposable ...
Tags: mobile MicroThermX system, Turky distribution, clinical technology
Maquet Cardiovascular has gained US and European marketing rights for its new SENSATION PLUS 7.5Fr. 40Cc intra-aortic balloon (IAB) catheter, following the US Food and Drug Administration (FDA) and CE mark approvals respectively. The ...
Tags: marketing rights, catheter, FDA
Accuray has received 510(k) clearance for its new CyberKnife M6 Series from the US Food and Drug Administration (FDA). Designed for use in stereotactic radiosurgery (SRS) and stereotactic body radiation therapy (SBRT) treatments, the ...
Tags: FDA, stereotactic radiosurgery, stereotactic body radiation therapy
Covidien will market its Nellcor bedside respiratory patient monitoring system in the US and European Economic Area (EEA), following the Food and Drug Administration and CE mark approvals. The new system, which can connect to the ...
Tags: respiratory monitoring system, FDA, clinical technology
The US Food and Drug Administration (FDA) has approved St Jude Medical's Amplatzer Vascular Plug 4. Amplatzer Plug is delivered using a standard diagnostic catheter and is designed for use in transcatheter embolization procedures ...
Tags: FDA, Amplatzer Vascular Plug 4, embolization
Dole Fresh Vegetables, a subsidiary of Dole Food, is recalling 2,598 cases of bagged salad in the US, as the products may be contaminated with Listeria monocytogenes. The recall was initiated after a sample of Dole Hearts of Romaine salad ...
Tags: bagged salad, Listeria monocytogenes, affected product
The US Food and Drug Administration (FDA) has granted 510(k) clearance to Semprus BioSciences' vascular access catheter, designed to provide peripheral access to the central venous system. Using Semprus Sustain technology, the ...
Indian producer of polyester granules, JBF Industries has awarded a contract to plant engineering and construction company Uhde Inventa-Fischer to build a PET plant in Geel, Belgium. The plant will have an annual total name plate capacity ...
Tags: PET plant, MTR and FTR technologies, food applications
Food service disposables and food packaging producer Pactiv has introduced the new EarthChoice 25 Percent Post Consumer Recycled Content Foam Foodservice packaging products for disposable food service needs. According to the US-based ...
Tags: Foodservice Packaging Containers, Containers, Foodservice Packaging
Pfizer has won US FDA approval for its rheumatoid arthritis (RA) therapy, Xeljanz (tofacitinib citrate) 5mg twice daily, indicated for patients who failed to respond to methotrexate. Xeljanz can be used as a single treatment regime or as ...
Tags: Pfizer, tofacitinib citrate, Xeljanz
Takeda Pharmaceutical Company and H. Lundbeck have submitted a new drug application (NDA) to the FDA for vortioxetine (Lu AA21004), an investigational drug for the treatment of major depressive disorder (MDD). Vortioxetine is under ...
Tags: Takeda Pharmaceutical Company, major depressive disorder, MDD
The US Food and Drug Administration (FDA) has cleared Halt Medical's minimally invasive technology, designed for treating uterine fibroids. The Acessa technology, which is designed for preserving the normal function of the uterus, ...
Furiex Pharmaceuticals said Takeda Global Research & Development Center has resubmitted New Drug Applications (NDAs) to the US Food and Drug Administration (FDA) for alogliptin and fixed-dose combination therapy alogliptin and pioglitazone ...
Tags: Furiex Pharmaceuticals, NDAs, alogliptin and pioglitazone