The US Food and Drug Administration (FDA) has granted more than $3.5m to various pediatric device consortia to encourage the development and availability of medical devices for children. This grants program is administered by the FDA's ...
Tags: Pediatric Medical Device, Medicine
Actuated Medical, a US-based medical device company, has obtained the additional US Food and Drug Administration (FDA) approval for its TubeClear system. The company has added several new clearing stem models for the TubeClear system and ...
Tags: Actuated Medical, medical device
Garden Fresh Foods is recalling about 19,054 pounds of ready-to-eat chicken and ham products, as they may be contaminated with Listeria monocytogenes, the US Department of Agriculture’s Food Safety and Inspection Service (FSIS) ...
Bayer HealthCare Pharmaceuticals, a subsidiary of Bayer, has obtained two separate orphan drug designations from the US Food and Drug Administration's (FDA) Office of Orphan Products Development for its investigational, oral medication ...
Tags: Drug Designations, Medicine
Danish pharmaceutical company H. Lundbeck and Japanese drugmaker Otsuka Pharmaceutical have announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended marketing approval for ...
Purdue Pharma has obtained approval from the US Food and Drug Administration (FDA) for the launch of a new 15mcg/hr dosage strength of Butrans (buprenorphine) Transdermal System CIII. Following the approval, Butrans will be available in ...
Tags: Pain Drug, Purdue Pharma
Medtronic, a US-based manufacturer of implantable heart-rhythm devices, has obtained the US Food and Drug Administration (FDA) approval for the Complete SE (self-expanding) vascular stent for use in superficial femoral artery (SFA) and ...
Tags: Medtronic, Lower Extremities
Luminex, a biotechnology company, has obtained the US Food and Drug Administration (FDA) and European approvals for a new personalized medicine genotyping assay, xTAG CYP2C19 kit. xTAG CYP2C19 kit is a comprehensive genotyping assay that ...
Tags: Genotyping Assay, Luminex
Solana Surgical, an extremity orthopedic products company, has introduced its FuseFORCE SuperElastic fixation system, designed for orthopedic and podiatric surgeons’ use in fusing the small joints in the foot and ankle, and hand and ...
Tags: Solana Surgical, Fixation System
The US Food and Drug Administration (FDA) has issued final guidance on how it will handle regulation of medical apps, which are software programs that run on mobile communication devices and perform the same functions as traditional medical ...
Tags: Mobile Medical Apps
eHealth, an online private health insurance exchange, has selected and inked a contract to integrate Intuit’s TurboTax (INTU), with its online health insurance comparison and enrollment tools. Following completion of the ...
Tags: Health Insurance, Service
US-based biopharmaceutical firm Tracon Pharmaceuticals has started dosing in a Phase Ib clinical of TRC105 for the treatment of patients with metastatic renal cell carcinoma. The trial evaluates the combination of TRC105 and a standard ...
Tags: Tracon, Carcinoma Drug
Medical imaging technology company Toshiba America Medical Systems has announced that it will launch its Aquilion large bore CT system at American Society of Radiation Oncology annual meeting in Atlanta. The US Food and Drug ...
The US Food and Drug Administration (FDA) has finalized a new rule for the unique device identification (UDI) system, designed to provide a consistent and clear way to identify medical devices. The FDA worked jointly with industry, ...
Tags: Unique Device, Medicine
Swiss drugmaker F. Hoffmann-La Roche has announced that the EU’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending authorization of Kadcyla as a single agent for the treatment of adult ...
Tags: Breast Cancer Drug