Janssen Biotech and Janssen Biologics have submitted a supplemental biologics license application (sBLA) to the US Food and Drug Administration (FDA) and a Type II Variation to the European Medicines Agency (EMA) seeking approval of Simponi ...
Tags: Simponi, golimumab, active ulcerative colitis, anti-tumor necrosis factor
Cardiovascular diagnostics developer BG Medicine has filed a 510(k) Premarket Notification with the US Food and Drug Administration (FDA) for regulatory clearance for the ARCHITECT Galectin-3 assay. Used with Abbott's fully automated ...
The US Food and Drug Administration (FDA) has cleared Bausch + Lomb's enVista glistening-free, single-piece hydrophobic acrylic Intraocular Lens (IOL). enVista lens, developed by Advanced Vision Science (AVS), is designed to provide ...
Tags: FDA, Bausch+Lomb's, enVista lens
Sedona Labs is voluntarily recalling certain lots of iFlora Kids Multi-Probiotic dietary supplement due to a possible Salmonella contamination, according to the US Food and Drug Administration (FDA). The recall was initiated after Corn ...
Tags: dietary supplement, Salmonella contamination, fatal infections
The US Food and Drug Administration (FDA) has granted 510(k) approval to Synergetics' VersaVIT vitrectomy system for use during performing retinal surgeries. Synergetics president and CEO David Hable said, "We believe that VersaVIT is ...
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
BG Medicine has announced the availability of galectin-3 testing services through Atherotech Diagnostics Lab. Atherotech leverages BGM Galectin-3 test to offer galectin-3 testing. The BGM Galectin-3 test was cleared as an aid in ...
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
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
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 ...
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