The US Food and Drug Administration (FDA) has approved US-based StemCells’ investigational new drug (IND) application for clinical testing of its HuCNS-SC human neural stem cells as a treatment for spinal cord injury. StemCells is ...
Tags: Spinal Cord Injury, Medicine
Corrosion control products manufacturer Cortec has launched a multimetal corrosion protection paper, VpCI-144, powered by Nano VpCI. Built with recyclable and repulpable technology, the new paper is said to be an environmentally safe ...
Tags: Cortec, Protection Paper
Beckman Coulter, a manufacturer of biomedical laboratory instruments, has obtained the 510(k) approval from the US Food and Drug Administration (FDA) for its Access AccuTnI+3 troponin I assay for use on the UniCel DxI series of immunoassay ...
Tags: Beckman Coulter, Cardiac Disease
PointCross Life Sciences, a PointCross company, has secured a $20m indefinite delivery, indefinite quantity (IDIQ) contract from the U.S. Food and Drug Administration (FDA) for providing software development and life cycle management of ...
Tags: PointCross, Life Sciences
The US Food & Drug Administration (cof Orphan Product Development has granted orphan drug designation for Lumena Pharmaceuticals' LUM001 clinical program. Lumena obtained orphan designation for LUM001 in four rare cholestatic liver ...
Tags: Orphan Drug, Rare Liver Diseases
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
US-based in vitro diagnostic company Venaxis announced that the Data and Safety Monitoring Board (DSMD) has recommended the continuation of pivotal clinical trial of the APPY1 test, a multiple biomarker-based assay for identifying patients ...
Tags: Appy1 Test, Clinical Trial
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
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
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
Mohawk is committed to continuous innovation proved by the company's powerful investments in the triexta and nylon categories. Today, P.E.T. carpets represent a $1.5+ billion market, according to the company. Mohawk has invested $180 ...