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St. Jude Medical announces results of Genesis neurostimulator trial on chronic migraine

St. Jude Medical, Inc., a global medical device company, today announced study results on the safety and efficacy of peripheral nerve stimulation (PNS) of the occipital nerve for the management of pain and disability associated with chronic migraine, a debilitating condition that affects millions worldwide.

23 Jun 2011

FGS expands service offering to European market through ISO 13485 medical certification

Flextronics Global Services (FGS), a business unit of Flextronics, today announced that it is expanding its service offering to the medical market in Europe through ISO 13485 medical certification at its Budapest facility.

22 Jun 2011

FDA to beef up monitoring of imports

As Food and Drug Administration (FDA) commissioner, Dr. Margaret A. Hamburg has been trying to correct inadequately controlled imported food and drugs overwhelming her organization’s ability to monitor them.

21 Jun 2011

FDA's draft guidance document addresses artificial pancreas system for type 1 diabetes

The U.S. Food and Drug Administration today issued draft guidance that will help advance the development and approval of an artificial pancreas system to treat type 1 diabetes in the United States.

21 Jun 2011

Wayne State team receives $330,000 NSF grant to develop 3-D neural probe for tinnitus

A team of Wayne State University researchers was awarded $330,000 from the National Science Foundation (NSF) to develop a 3-D neural probe. Their aim is to develop an implantable device that will suppress tinnitus, a neurological disorder that affects more than 250 million people worldwide.

21 Jun 2011

Sentrx, TransPerfect collaborate to offer Trial Interactive Portal Technology

TransPerfect and Sentrx have announced a collaboration involving TransPerfect's Trial Interactive Portal Technology, which will streamline end-to-end global drug safety capabilities in both clinical and post-marketing event management.

21 Jun 2011

FDA's new strategy calls for coalitions of international regulators, increased data sharing

The U.S. Food and Drug Administration today unveiled a new strategy to meet the challenges posed by rapidly rising imports of FDA-regulated products and a complex global supply chain in a report called the "Pathway to Global Product Safety and Quality."

20 Jun 2011

Derma Sciences to raise $29M through private placement

Derma Sciences, Inc., a medical device and pharmaceutical company focused on advanced wound care, today announced it has entered into definitive agreements with select institutional investors to raise gross proceeds of approximately $29 million.

20 Jun 2011

Teleflex, Amerinet sign deal for VasoNova Vascular Positioning System

Teleflex Incorporated, a leading global provider of medical devices for critical care and surgery, has announced the addition of VasoNova Vascular Positioning System to its existing Peripherally Inserted Central Catheters agreement with Amerinet. The agreement began May 1, 2011 and runs through April 30, 2014.

20 Jun 2011

Medtronic Valiant stent graft safe and effective for patients with thoracic aortic aneurysm

An innovative medical device used in the minimally invasive treatment of thoracic aortic aneurysms, the Valiant Thoracic Stent Graft System from Medtronic, Inc., delivered excellent clinical results through one year of patient follow-up in the company's U.S. pivotal study, VALOR II, according to data presented today at a meeting for vascular surgeons.

From Medtronic 20 Jun 2011

Dems introduce bills to push for Medicare negotiated drug pricing

Congressional Democrats have introduced legislation to let Medicare negotiate prescription drug prices - a move that could result in significant savings, the bill supporters say. They are urging that their measure be included in the effort to raise the debt ceiling.

18 Jun 2011

Patients still being enrolled in clinical trial for new peripheral vascular disease treatment

The first three patients to undergo an investigational surgical procedure for peripheral vascular disease that involves the patient's own stem cells continue to do well, reports the University of Louisville surgeon who is the principal investigator.

18 Jun 2011

St. Jude Medical introduces HD VantageView System for enhancing EP lab workflow

St. Jude Medical, Inc., a global medical device company, today announced the launch of the VantageView™ System in the United States and Europe. The VantageView System is a state-of-the-art, high-definition (HD) monitor that eliminates the need for multiple monitors and enhances workflow by improving the visualization of critical case information in the electrophysiology (EP) lab.

15 Jun 2011

NIH awards $20 million research grant to University of Kentucky

The National Institutes of Health (NIH), the largest government funding source for biomedical research in the United States, has awarded $20 million to the University of Kentucky to move research discoveries to health care solutions more quickly.

15 Jun 2011

OncoSec Medical third quarter net loss increases to $491,000

OncoSec Medical Incorporated, which is developing its advanced-stage ElectroOncology therapies to treat solid tumor cancers, today reported financial results for the quarter ended April 30, 2011.

15 Jun 2011

HTX provides $750,000 funding to Profound Medical through Technology Assessment Program

HTX, a member of the Canadian Venture Capital Association, announced today it provided $750,000 in financing to Profound Medical Inc. through their Technology Assessment Program.

15 Jun 2011

BDC releases new technology to aid medical device industry with product design testing

Endovascular stents, stent grafts, and transcatheter heart valve (TAVI) devices provide enhanced methods for clinical treatment of cardiac and vascular disease. Further research and product development is currently ongoing worldwide to address complications associated with these devices.

15 Jun 2011

CerebralRx launches FitNeS vagus nerve stimulation system for treating epilepsy

CerebralRx, a newly formed spin-off of implantable neuromodulation systems developer BioControl Medical, has announced market entry with the launch of its FitNeS vagus nerve stimulation system.

14 Jun 2011

Enox to receive European patent for 'Device and Method for Administering Therapeutic Agents'

Enox Biopharma, Inc., a leader in the development of innovative solutions for infections associated with medical devices, today announced that it has received notification from the European Patent Office that its patent application entitled "Device and Method for Administering Therapeutic Agents" has been approved and a patent will be granted.

14 Jun 2011

inVentiv Health acquires i3 CRO

inVentiv Health, Inc., offering best-in-class clinical, consulting and commercial services to the healthcare industry, today announced it has completed the acquisition of i3, a top-tier contract research organization (CRO) to the pharmaceutical, biotech and medical device industries. i3 was previously owned by Ingenix, a UnitedHealth Group company.

13 Jun 2011

Medical Devices News and Research

St. Jude Medical announces results of Genesis neurostimulator trial on chronic migraine

FGS expands service offering to European market through ISO 13485 medical certification

FDA to beef up monitoring of imports

FDA's draft guidance document addresses artificial pancreas system for type 1 diabetes

Wayne State team receives $330,000 NSF grant to develop 3-D neural probe for tinnitus

Sentrx, TransPerfect collaborate to offer Trial Interactive Portal Technology

FDA's new strategy calls for coalitions of international regulators, increased data sharing

Derma Sciences to raise $29M through private placement

Teleflex, Amerinet sign deal for VasoNova Vascular Positioning System

Medtronic Valiant stent graft safe and effective for patients with thoracic aortic aneurysm

Dems introduce bills to push for Medicare negotiated drug pricing

Patients still being enrolled in clinical trial for new peripheral vascular disease treatment

St. Jude Medical introduces HD VantageView System for enhancing EP lab workflow

NIH awards $20 million research grant to University of Kentucky

OncoSec Medical third quarter net loss increases to $491,000

HTX provides $750,000 funding to Profound Medical through Technology Assessment Program

BDC releases new technology to aid medical device industry with product design testing

CerebralRx launches FitNeS vagus nerve stimulation system for treating epilepsy

Enox to receive European patent for 'Device and Method for Administering Therapeutic Agents'

inVentiv Health acquires i3 CRO

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