News
Genzyme to transfer more manufacturing to Hospira
July 8, 2010 10:38 am | by Mass High Tech: The Journal of New England Technology | CommentsGenzyme Corp. is expanding a deal designed to transfer more so-called fill-finish manufacturing work to Hospira Worldwide Inc. – part of an agreement with the U.S. FDA to comply with an enforcement action against the Cambridge-based biotechnology company.
PEAK Surgical Introduces PEAK PlasmaBlade(R) 3.0S
July 8, 2010 10:37 am | by Bio-Medicine.Org | CommentsPALO ALTO, Calif. , July 8 /- PEAK Surgical, Inc. today announced the launch of the PEAK PlasmaBlade® 3.0S dissection device following 510(k) clearance from the U.S. Food and Drug Administration (FDA). This revolutionary product features a 3.0mm wide blade for even greater cutting...
Unprecedented Donation Made by Mrs. Lily Safra to the Institute for Brain and Spinal Cord Disorders in Paris
July 8, 2010 10:37 am | by Bio-Medicine.Org | CommentsPARIS , July 8, 2010 /- Professor Gerard Saillant , President of the Institute for Brain and Spinal Cord Disorders (ICM), announced today an unprecedented donation of EUR8,000,000 from Mrs. Lily Safra . It is the largest single donation made by a private individual to the ICM. Professor Saillant...
ECRI Institute Adds 4,000 New Terms to Universal Medical Device Nomenclature Systemâ„¢
July 8, 2010 10:35 am | by Bio-Medicine.Org | CommentsFree license gives access to 24,544 terms, including genetic testing and device software PLYMOUTH MEETING, Pa. , July 8 /PRNewswire-USNewswire/ -- ECRI Institute's Universal Medical Device Nomenclature System™, the most comprehensive medical device taxonomy, announces the...
Exagen Diagnostics Receives Lab Accreditation From College of American Pathologists
July 8, 2010 10:35 am | by Bio-Medicine.Org | CommentsALBUQUERQUE, N.M. , July 8 /- Exagen Diagnostics, Inc., a molecular diagnostics laboratory that discovers, develops and markets proprietary genomic tests, has been awarded accreditation by the Accreditation Committee of the College of American Pathologists (CAP). The CAP is a leading...
Qualaquin (quinine sulfate): New Risk Evaluation and Mitigation Strategy - Risk of serious hematological reactions
July 8, 2010 10:31 am | by U.S. Food & Drug Administration | CommentsNew Risk Management Plan. Reports of serious side effects in patients using Qualaquin "off-label" for night time leg cramps.
MDT Forum
July 8, 2010 7:38 am | CommentsThe MDT community forum is a great location to discuss new trends, share tips, give opinions, and exchange ideas.
PMA Final Decisions for May 2010
July 8, 2010 7:37 am | by U.S. Food & Drug Administration | CommentsThese are Premarket Approvals (PMA), Product Development Protocols (PDP), Supplement and Notice Decisions for January 2010
Federal Register: Guidance for Humanitarian Device Exemption Holders, Institutional Review Boards, Clinical Investigators, and Food and Drug Administration Staff; Humanitarian...
July 8, 2010 7:31 am | by U.S. Food & Drug Administration | CommentsThis guidance answers commonly asked questions about Humanitarian Use Devices (HUDs) and applications for HDEs.
Community Health Systems buys hospital in SC
July 8, 2010 6:45 am | by The Associated Press | CommentsHospital operator Community Health Systems Inc. has acquired Marion Regional Healthcare System, expanding its presence in South Carolina.Terms of the deal were not disclosed.Community, which is based in Franklin, Tenn., said the system includes Marion Regional Hospital, a 124-bed, full service...
ESMO publishes updated guidelines on cancer care
July 8, 2010 6:36 am | by EurekAlert | Comments(European Society for Medical Oncology) The European Society for Medical Oncology just released an enhanced and revised set of clinical recommendations designed to help oncologists deliver the best quality care to their patients.The ESMO Clinical Practice Guidelines offer vital,...
Perfusion CT may be used as a noninvasive tool in detection of hepatic toxicity
July 8, 2010 6:36 am | by EurekAlert | Comments(World Journal of Gastroenterology) A research team from China investigated the microcirculation changes in liver of patients with tumor during chemotherapy by perfusion computed tomography (CT). Their study suggested that chemotherapy affects hepatic microcirculation in patients...
Sanofi-aventis reported to grow Cambridge presence
July 8, 2010 6:35 am | by Mass High Tech: The Journal of New England Technology | CommentsFrench drug developer Sanofi-aventis SA is growing its presence in Cambridge, with plans to add 300 jobs and a $65 million expansion investment, according to a published report today.
Lantheus resigns with MDS Nordion; supplies to resume once AECL reactor restarts
July 8, 2010 5:45 am | by The Associated Press | CommentsCanada's leading nuclear medicine company is gearing up for the restart of Atomic Energy of Canada's aging reactor in Chalk River, Ont.MDS Nordion, which now forms the core of Canadian life-science company MDS Inc. (TSX:MDS), says it has a new contract with its primary customer.Nordion will...
House strikes gift ban in effort to boost business
July 8, 2010 5:38 am | by Mass High Tech: The Journal of New England Technology | CommentsReversing course on a new law aimed at diminishing the influence on doctors of pharmaceutical and medical device companies, the House on Wednesday voted to strike the so-called gift ban law, which critics say has hurt commerce in the medical and restaurant industries.
