Skip to : [Content] [Navigation]

Medical Device Link News

Back to the Main News Page

NewsEdge Logo
  Medical Device Approval Process
 
back to Editors' Picks | refresh headlines
09/08/2010 09:30:00 AM
Cytta Delivers First Major Proposal for Remote Medical Monitoring System
09/08/10 -- Cytta Corp's CEO Stephen Spalding is pleased to announce that, after a series of well received presentations and demonstrations, Cytta has been invited to provide its first major proposal to a major healthcare payor/provider to develop an individualized monitoring system.

[Market Wire]
09/08/2010 09:00:37 AM
Current Clinical Findings on the Therapeutic Use of Concentrated Bone Marrow-Derived Stem Cells Will be Presented During ThermoGenesis Symposium at Leading Cellular Therapy Meeting in Europe
RANCHO CORDOVA, Calif., Sept. 8 ThermoGenesis Corp., a leading supplier of innovative products and services that process and store adult stem cells, said today that findings from the use of concentrated bone marrow-derived stem cells in orthopedic and Critical Limb Ischemia applications will be presented at the upcoming International Stem Cell Therapy-Europe regional meeting in Belgirate, Italy.

[PR Newswire]
09/08/2010 09:00:07 AM
BioMimetic Therapeutics PMA Remains on Track
Augment Injectable Receives Device Designation. United States and European Patent Portfolio Significantly Enhanced.

[Business Wire]
09/08/2010 08:30:21 AM
Lucid, Inc. To Present at the Rodman & Renshaw Healthcare Conference on September 15
Lucid, Inc., the creator and distributor of the VivaScope® confocal imager, the only FDA approved, noninvasive, diagnostic device for imaging skin cancer, today announced that Jay M. Eastman, Chief Executive Officer, will be presenting at the Rodman & Renshaw Healthcare Conference on Wednesday, September 15, 2010 at 10:00 a.m. Eastern time . The conference will be held at the New York Palace Ho...

[Business Wire]
09/08/2010 06:22:22 AM
Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document for Certain Percutaneous Transluminal...
Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty Catheters; Availability. Notice.

[Federal Register]
09/08/2010 06:21:44 AM
Cardiovascular Devices; Reclassification of Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters
Final rule. CFR Part: "21 CFR Part 870" Citation: "75 FR 54493" Document Number: "Docket No. FDA-2000-P-0924" Page Number: "54493" "Rules and Regulations" SUMMARY: The Food and Drug Administration is reclassifying the device type, standard percutaneous transluminal coronary angioplasty catheters, from class III into class II.    EFFECTIVE DATE: This final rule is effective October 8, 2010.

[Federal Register]
09/08/2010 06:21:32 AM
Federal Register Table of Contents
Citation: "75 FR III" Page Number: "III" "Table of Contents"

[Federal Register]
09/08/2010 03:04:28 AM
Device Made with OXPEKK®-IG Polymer Receives ANVISA Approval
Brazilian Market Growth Anticipated for OXPEKK-IG, OPM's branded PEKK. Oxford Performance Materials is pleased to announce that a medical device produced with its OXPEKK®-IG polymer has received ANVISA clearance. "The pursuit of this important milestone now completes the major elements of our regulatory strategy for the Americas.

[PR Web]
09/07/2010 12:36:01 PM
Program Cuts Red Tape for Volunteer Health Professionals
Using New National Website before a Disaster Saves Time When Every Minute Counts. To make volunteering in an emergency easier for health professionals, the U.S. Department of Health and Human Services' Office of the Assistant Secretary for Preparedness and Response launched a national website today for the Emergency System for Advance Registration of Volunteer Health Professionals.

[Business Wire]
09/07/2010 11:23:02 AM
FDA Grants Market Clearance for Erchonia's Zerona Laser Proven Safe and Effective for Circumference Reduction of the Waist, Hips and Thighs
09/07/10 -- Erchonia Corporation, the world's leading manufacturer in low-level laser technology, has been granted market clearance by the U.S. Food and Drug Administration for the non-invasive body contouring device, the Zerona.

[Market Wire]
09/07/2010 10:00:12 AM
Whittemore Peterson Institute and Cerus Announce Inactivation of XMRV in Platelets and Red Blood Cells by the INTERCEPT Blood System
- Data Confirming Inactivation of XMRV and MLV-Related Viruses is Presented at 1st International XMRV Workshop - The Whittemore Peterson Institute for Neuro-Immune Disease and Cerus Corporation presented data at today's NIH-sponsored 1st International Workshop on XMRV which demonstrates the efficacy of Cerus' INTERCEPT Blood System to inactivate XMRV and other MLV-related viruses in donated blood.

[Business Wire]
09/07/2010 08:15:24 AM
Ingen Technologies Signs Sales Contract With Healthstar Associates Expands U.S. Respiratory Market Distribution Throughout Midwest
Ingen Technologies, Inc. announced today that it has signed a definitive sales agreement with Healthstar Associates Incorporated to expand distribution throughout the mid-west U.S.. Healthstar Associates is a Regional Medical Sales and Marketing company headquartered in Lincolnwood, Illinois and doing business for almost 20 years.

[GlobeNewswire]
09/07/2010 08:05:01 AM
AtheroMed, Inc. Announces Launch of EASE Clinical Trial to Evaluate Peripheral Arterial Disease Treatment
Phoenix Atherectomy Catheter Treats Atherosclerotic Disease in the Legs. AtheroMed, Inc. announced today the start of enrollment in the EASE study to evaluate the safety and effectiveness of the Phoenix Atherectomy catheter, a minimally invasive device for the treatment of peripheral arterial disease in the legs.

[Business Wire]
09/07/2010 08:05:00 AM
Somaxon Pharmaceuticals Announces Commercial Availability of Silenor
Somaxon Pharmaceuticals, Inc., a specialty pharmaceutical company, today announced that Silenor® now is commercially available by prescription in the United States.

[Business Wire]
09/07/2010 08:00:37 AM
Unilife to Participate in Three Investor Conferences
LEWISBERRY, Pa., Sept. 7 Unilife Corporation, today announced that its Chief Executive Officer, Alan Shortall,  will be presenting at three upcoming investor conferences taking place in New York and Boston.  . Each of the conference presentations will be broadcast over the Internet as a "live" listen only Webcast. About Unilife Corporation.

[PR Newswire]
  previous  |  next

Copyright © 2010 Acquire Media. All rights reserved.


Back to the Main News Page | Back to the Top of This Page