The Essential Resource for the Medical Design Engineering Community
Iran holds firm on nuclear 'rights' as talks loom
April 8, 2012 8:45 am | by BRIAN MURPHY - Associated Press - Associated Press | News | CommentsDUBAI, United Arab Emirates (AP) — When talks between Iran and world powers collapsed last year, Tehran quickly blamed the West for trying to trample its "nuclear rights." The Iranian line appears little changed — signaling that critical negotiations could begin this week where the impasse left...
SciFri 040612 Hour 1: NYC Mayor Bloomberg, Paleoanthropologist Ian Tattersall
April 7, 2012 3:41 am | Podcasts | CommentsMayor Michael Bloomberg discusses his vision to turn the Big Apple into the technology capital of the world, and paleoanthropologist Ian Tattersall discusses our human origins.
FDA Approves Amyvid™ (Florbetapir F 18 Injection) for Use in Patients Being Evaluated for Alzheimer's Disease and Other Causes of Cognitive Decline
April 7, 2012 3:36 am | by Bio-Medicine.Org | News | CommentsINDIANAPOLIS, April 6, 2012 /- Eli Lilly and Company (NYSE: LLY ) and Avid Radiopharmaceuticals, Inc., a wholly owned subsidiary of Lilly, today announced the U.S. Food and Drug Administration (FDA) approval of Amyvid™, a radioactive diagnostic agent indicated for brain...
Continue Routine Screening After False-positive Mammo Result
April 7, 2012 3:34 am | by Diagnostic Imaging | News | CommentsScreening mammograms, often associated with false-positive results in breast cancer-free women, may indicate underlying pathology that still could result in breast cancer, researchers said.
Patients Want Online Access to Radiology Reports
April 7, 2012 3:34 am | by Diagnostic Imaging | News | CommentsMost patients want online access to their test results — even if the findings are difficult to understand.
CDRH Misses MedSun Goals, Cites Success in MDR Reviews, Other Areas
April 6, 2012 2:31 pm | by U.S. Food & Drug Administration | News | CommentsRecent agency data show CDRH making slow but steady progress toward several strategic goals — but missing the mark on the Medical Product Safety Network (MedSun) initiative.
Senators Set June Deadline for Sunshine Implementation
April 6, 2012 2:30 pm | by U.S. Food & Drug Administration | News | CommentsThe senators who co-authored the Physician Payments Sunshine Act are trying once more to exercise their legislative oversight — this time setting a June deadline for overdue implementation of the rules.
Research undercounted and excluded MAUDE data reports for Medtronic product resulting in substantial factual errors
April 6, 2012 11:45 am | by The Associated Press | News | CommentsResearch undercounted and excluded MAUDE data reports for Medtronic product resulting in substantial factual errors ST. PAUL, Minn.--(BUSINESS WIRE)--Apr 6, 2012-- St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced it is seeking a retraction of the manuscript...
Arteriocyte Receives FDA Approval to Initiate Compartment Syndrome Trial for Amputation Prevention Focused on Wounded Warriors
April 6, 2012 7:45 am | by The Associated Press | News | CommentsArteriocyte, a leading biotechnology company with offices in Cleveland, Ohio and Hopkinton, Massachusetts announced today approval from the Food and Drug Administration (FDA) to initiate a Phase I clinical trial using its Magellan MAR01T technology in the treatment of Compartment Syndrome. The...
New stem cell line provides safe, prolific source for disease modeling and transplant studies
April 6, 2012 5:38 am | News | CommentsResearchers have generated a new type of human stem cell that can develop into numerous types of specialized cells, including functioning pancreatic beta cells that produce insulin. Called endodermal progenitor (EP) cells, the new cells show two important advantages...
In children born with severe heart defect, surgical management has little effect on neuro outcomes
April 6, 2012 5:37 am | News | CommentsIn the largest multicenter clinical trial of children undergoing early-stage surgery for single-ventricle heart defects, differences in intraoperative management did not significantly affect neurodevelopmental outcomes at 14 months of age.
Guidance for Industry and Food and Drug Administration Staff - User Fees for 513(g) Requests for Information
April 6, 2012 5:30 am | by U.S. Food & Drug Administration | News | CommentsTitle II of the Food and Drug Administration Amendments Act of 2007 (FDAAA), also termed the Medical Device User Fee Amendments of 2007, P.L. 110-85, extends FDA?s authority to collect medical device user fees by establishing a fee for ?a request for...
Guidance for Industry and Food and Drug Administration Staff - FDA and Industry Procedures for Section 513(g) Requests for Information under the Federal Food, Drug, and Cosmet...
April 6, 2012 5:30 am | by U.S. Food & Drug Administration | News | CommentsThe purpose of this guidance is to establish procedures for submitting, reviewing and responding to requests for information regarding the class in which a device has been classified or the requirements applicable to a device under the Federal Food, Drug,
Detecting breast cancer's fingerprint in a droplet of blood
April 6, 2012 5:28 am | News | CommentsOne in eight women will be diagnosed with breast cancer during her lifetime. The earlier cancer is detected, the better the chance of successful treatment and long-term survival. However, early cancer diagnosis is still challenging as testing by mammography remains cumbersome...
Devon Medical Products Receives FDA 510(k) Clearance for extriCARE 2400 Negative Pressure Wound Therapy (NPWT) System
April 6, 2012 5:16 am | News | CommentsKING OF PRUSSIA, Pa.--(BUSINESS WIRE)--Devon Medical Products, a global medical device designer, manufacturer, and distributor, today announced it has received FDA 510(k) clearance to market its extriCARE™ 2400 Negative Pressure Wound Therapy (NPWT) system.
