News
Huber Needles: Recall - Risk of Coring
August 26, 2010 12:35 pm | by U.S. Food & Drug Administration | CommentsRisk of infection, damage or death of tissue, swelling, or other serious adverse health consequences occurring as a result of the core travelling through blood vessels into the patient's lungs.
ThermoGenesis Announces Reverse Stock Split Effective on NASDAQ Capital Market August 27, 2010
August 26, 2010 12:34 pm | by Bio-Medicine.Org | CommentsRANCHO CORDOVA, Calif., Aug. 26 /- ThermoGenesis Corp. (Nasdaq: KOOL ), a leading supplier of innovative products and services that process and store adult stem cells, said it has filed a Certificate of Amendment to its Amended and Restated Certification of Incorporation to effect its...
meridianEMR, Inc. Honored by Inc. 5000 for Second Year in a Row as One of the Fastest-Growing Private Companies
August 26, 2010 12:34 pm | by Bio-Medicine.Org | CommentsLIVINGSTON, N.J., Aug. 26 /- meridianEMR, Inc., a leading provider of electronic medical records systems, electronic prescribing and advanced healthcare analytics, announced today that Inc. Magazine ranked the company No. 1717 in its annual ranking of the 5,000 fastest-growing...
Deloitte Issue Brief: Mobile Personal Health Records May Offer Consumers Key to Technology-Enabled Self-Care
August 26, 2010 12:34 pm | by Bio-Medicine.Org | CommentsWASHINGTON, Aug. 26 /- The convergence of personal health records and mobile communication devices may provide the mechanism to engage consumers to use technology to enhance self-care, taking cost out of the health care system, according to a new Deloitte Issue Brief released today by the...
Microflex Acquires Black Dragon®, Examination Gloves From MedTexx
August 26, 2010 12:34 pm | by Bio-Medicine.Org | CommentsLAKE FOREST, Ill., Aug. 26 /- Microflex Corporation (Lake Forest, IL), a division of BarrierSafe Solutions International® (BSSI), a leading provider of latex and synthetic barrier protection, announced the acquisition of Black Dragon® examination gloves from MedTexx in...
NMT Medical appoints new CEO, reduces board
August 26, 2010 12:34 pm | by Mass High Tech: The Journal of New England Technology | CommentsMedical implant technology developer NMT Medical Inc. has appointed chief operating officer Richard Davis as chairman, president and CEO of the company, following disappointing results from a clinical trial earlier this year.
Luminex Announces Commercial Launch of New Cystic Fibrosis Test
August 26, 2010 12:33 pm | by Bio-Medicine.Org | CommentsAUSTIN, Texas, Aug. 26 /- Luminex Corporation (Nasdaq: LMNX ), the worldwide leader in multiplexed solutions, today announced the full commercial launch of its xTAG® Cystic Fibrosis 60 Kit v2, a new diagnostic test that can simultaneously screen a single blood sample for up to 60...
Fingerstick Devices to Obtain Blood Specimens: Initial Communication - Risk of Transmitting Bloodborne Pathogens
August 26, 2010 12:31 pm | by U.S. Food & Drug Administration | CommentsIncrease in reports of bloodborne infection transmission resulting from the shared use of fingerstick and point-of-care blood testing devices.
Use of Fingerstick Devices on More Than One Person Poses Risk for Transmitting Bloodborne Pathogens: Initial Communication
August 26, 2010 10:32 am | by U.S. Food & Drug Administration | CommentsCDC and FDA have noted a progressive increase in the reports of bloodborne infection transmission over the past 10 to 15 years (primarily hepatitis B virus), resulting from the shared use of fingerstick and POC blood testing devices...
Stryker Biotech to pay $1.35M settlement to Mass.
August 26, 2010 8:34 am | by Mass High Tech: The Journal of New England Technology | CommentsThe Massachusetts state attorney general's office has settled with Stryker Biotech LLC over allegations the company improperly marketed orthopedic products for indications that were not approved by the U.S. Food and Drug Administration.
Frankfurt am Main Emergency Medical Services Makes Masimo Rad-57 Pulse CO-Oximeters Mandatory for All Vehicles
August 26, 2010 8:33 am | by Bio-Medicine.Org | CommentsIRVINE, Calif., Aug. 26 /- Frankfurt am Main Emergency Medical Services (EMS) in Germany and Masimo (Nasdaq: MASI ), the inventor of rainbow® Pulse CO-Oximetry™, rainbow Acoustic Monitoring™, and Masimo SET® Measure-Through Motion and Low Perfusion pulse oximetry,...
Society of Interventional Radiology Supports Research for New M.S. Treatments
August 26, 2010 8:33 am | by Bio-Medicine.Org | CommentsFAIRFAX, Va., Aug. 26 /PRNewswire-USNewswire/ -- Recognizing that venous interventions may potentially play an important role in treating some patients who suffer from multiple sclerosis -- an incurable, disabling disease -- the Society of Interventional Radiology has issued a position...
Endologix Receives CE Mark Approval for Expanded Line of Powerlink Products and PowerFit Aortic Extensions
August 26, 2010 8:33 am | by Bio-Medicine.Org | CommentsIRVINE, Calif., Aug. 26 /- Endologix, Inc. (Nasdaq: ELGX), developer of minimally invasive treatments for aortic disorders, announced today that it received CE Mark approval to market its expanded offering of Powerlink® stent graft products and PowerFit™ Aortic Extensions...
Safety Investigation of Non-Coring (Huber) Needles: Updated August 26, 2010
August 26, 2010 8:31 am | by U.S. Food & Drug Administration | CommentsHuber needles are used to access ports implanted under the skin of chronically ill patients for repeated access to veins for the withdrawal of blood and infusion of medication, nutritional solutions, blood products, and imaging solutions...
Class I Medical Device Recall: Multi-Med, Inc., 22 Gauge x 1 inch Straight and Right Angle Huber Needles and Navilyst Medical Inc., Vaxcel Implantable Vascular Access Systems ...
August 26, 2010 8:30 am | by U.S. Food & Drug Administration | CommentsHuber needles are safety needles used on vascular access ports implanted in patients in need of repeated intravenous therapy. A "coring" Huber needle could damage the implanted port by removing silicone slivers from the access membrane...
