Medical Devices News and Research

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FTC presses for more competition on generic drugs

Some drug makers are using an indirect method to delay competition from low-cost generic products by promising not to introduce their own generic versions if a potential competitor delays its entry into the market, the Federal Trade Commission said in a report on Wednesday.

2 Sep 2011

Medtronic initiates U.S. post-approval study of Endurant AAA Stent Graft System

Leading the development of endovascular aortic repair (EVAR), Medtronic, Inc. today announced the start of its U.S. post-approval study of the Endurant AAA Stent Graft System, a medical device used to treat abdominal aortic aneurysms.

From Medtronic 2 Sep 2011

Microvisk introduces unique handheld device which monitors blood clotting status

Microvisk Technologies has introduced its unique handheld devices which monitor the blood clotting status of patients to the US market. Showcased at the prestigious American Association for Clinical Chemistry annual conference, the Microvisk devices attracted strong interest from distributors and potential partners ahead of clinical trials in major US medical centres this autumn and product launches in 2012.

31 Aug 2011

Bristol-Myers Squibb selects ICON as preferred provider for early phase clinical development

ICON plc, a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries, today announced that it has been chosen by Bristol-Myers Squibb Company as a preferred provider for full-service clinical pharmacology and exploratory clinical studies.

30 Aug 2011

FDA advisory committee postpones Panel review of Gen-Probe's PROGENSA PCA3 Assay

DiagnoCure, Inc., a life sciences company that develops and commercializes high‐value cancer diagnostic tests, announced today that Gen-Probe Incorporated, its commercial partner for the PCA3 test, received notice from the U.S. Food and Drug Administration (FDA) that the PROGENSA PCA3 Assay will not be reviewed by the Immunology Panel of FDA's Medical Devices Advisory Committee on October 14, 2011 as previously scheduled, but will be reviewed by the Panel at a later date.

30 Aug 2011

St. John Hospital enrolls first patient in Moxy- Drug Coated Balloon trial for PAD

Physicians at St. John Hospital and Medical Center have enrolled the first patient in Michigan in LEVANT2, a global, multicenter, randomized clinical trial evaluating the safety and effectiveness of the Moxy- Drug Coated Balloon for the treatment of peripheral arterial disease.

30 Aug 2011

European infusion therapy device market to reach €533 million by 2017: New report

According to a new report by iData Research, the leading global authority in medical device market research, the European infusion therapy device market, which includes needleless connectors, infusion pumps and intravenous (IV) sets, was valued at an estimated €443 million in 2010.

29 Aug 2011

FDA acts to prevent distribution of food from rodent-infested facility

At the request of the U.S. Food and Drug Administration, U.S. Marshals seized all FDA-regulated food susceptible to rodent and pest contamination or other filth held at the Durham, North Carolina, warehouse of CFSD, Inc., which does business as Chan's Food Service.

29 Aug 2011

FDA tips for tackling hurricanes

The FDA reminds consumers to take precautions for storing water and ensuring the safety of their food and medical supplies for themselves and their pets during and after this week's expected hurricane-related rain, possible flooding and power outages.

26 Aug 2011

European Journal of Heart Failure publishes results of BIOTRONIK Home-CARE clinical study

BIOTRONIK SE & Co. KG, a worldwide leader in manufacturing cardiac medical devices and pioneer of remote patient management solutions, announced today that results of the Home-CARE (Home Monitoring in Cardiac Resynchronization Therapy) clinical study were published in the European Journal of Heart Failure.

26 Aug 2011

Covidien pledges $375,000 to SIRF's discovery campaign

The Society of Interventional Radiology Foundation's Discovery Campaign, which seeks to further the growth of minimally invasive medicine into new areas of discovery, announced a major corporate pledge to that initiative. Covidien, a manufacturer of medical devices, pharmaceuticals and medical supplies, based in Mansfield, Mass., has pledged $375,000 and is a "Visionary" level supporter.

26 Aug 2011

CVRx introduces CE Mark approved Barostim neo for treatment of uncontrolled hypertension

CVRx, Inc., a private medical device company, introduced today its second-generation implantable device, the Barostim neo, for the treatment of uncontrolled hypertension. The Barostim neo features a new unilateral, 1mm electrode and a new smaller, more advanced stimulator to allow for more focused and efficient delivery of therapy. These improvements have led to shorter procedure times and extended longevity.

25 Aug 2011

HHS finalizes rule on medical research and confilcts of interest

The guidance, which is designed to help scientists avoid financial conflicts when conducting government-funded research, will take effect Aug. 24, 2012.

25 Aug 2011

Synovis Life Technologies third quarter net revenue increases 19% to record $21.0 million

Synovis Life Technologies, Inc., today reported its financial results for the fiscal third quarter ended July 31, 2011.

24 Aug 2011

First Edition: August 24, 2011

In today's headlines, Medicare tries bundled payments and HHS signals that it may give states a second chance to avoid a federally-run health insurance exchange.

24 Aug 2011

Sarcoma Oncology Center, Aethlon Medical to study ex vivo effectiveness of Hemopurifier

Aethlon Medical, Inc., the pioneer in developing therapeutic filtration devices to address infectious disease and cancer, announced today that it has entered into an agreement with the Sarcoma Oncology Center to study the ex vivo effectiveness of the Aethlon Hemopurifier to remove immunosuppressive exosomes from the blood of advanced-stage cancer patients.

24 Aug 2011

DATATRAK announces addition of eClinical Consulting Group to Connect Partner Program

DATATRAK International, Inc., a technology and services company focused on global eClinical solutions for the clinical trials industry, today announced the newest member of its Connect Partner Program, eClinical Consulting Group.

24 Aug 2011

NextDocs receives $10.3 million in Series A financing

NextDocs Corporation, the global leader in Microsoft SharePoint based software solutions for life sciences industries, today announced that the Company has received $10.3 million in a Series A financing from OpenView Venture Partners.

23 Aug 2011

Crimson announces publication of Japan Medical Device Digest

Crimson Life Sciences, a division of TransPerfect and the world's only ISO 13485 and ISO 14971-certified translation provider, today announced the publication of their Japan Medical Device Digest, a free monthly report that provides English translations of Japanese-language news items.

23 Aug 2011

Aptiv Solutions acquires Medical Device Consultants

Aptiv Solutions announced today the acquisition of Medical Device Consultants, Inc. (MDCI), a provider of expert medical device consulting and clinical trial management and execution.

23 Aug 2011

Medical Devices News and Research

FTC presses for more competition on generic drugs

Medtronic initiates U.S. post-approval study of Endurant AAA Stent Graft System

Microvisk introduces unique handheld device which monitors blood clotting status

Bristol-Myers Squibb selects ICON as preferred provider for early phase clinical development

FDA advisory committee postpones Panel review of Gen-Probe's PROGENSA PCA3 Assay

St. John Hospital enrolls first patient in Moxy- Drug Coated Balloon trial for PAD

European infusion therapy device market to reach €533 million by 2017: New report

FDA acts to prevent distribution of food from rodent-infested facility

FDA tips for tackling hurricanes

European Journal of Heart Failure publishes results of BIOTRONIK Home-CARE clinical study

Covidien pledges $375,000 to SIRF's discovery campaign

CVRx introduces CE Mark approved Barostim neo for treatment of uncontrolled hypertension

HHS finalizes rule on medical research and confilcts of interest

Synovis Life Technologies third quarter net revenue increases 19% to record $21.0 million

First Edition: August 24, 2011

Sarcoma Oncology Center, Aethlon Medical to study ex vivo effectiveness of Hemopurifier

DATATRAK announces addition of eClinical Consulting Group to Connect Partner Program

NextDocs receives $10.3 million in Series A financing

Crimson announces publication of Japan Medical Device Digest

Aptiv Solutions acquires Medical Device Consultants

Industry Focus eBook - Medical Devices (3rd Edition) eBook

Designing fluidic architecture for scalable diagnostic platforms

Evaluating new approaches for rare disease genomics

Expanding access to NMR with the Fourier 80 Duo

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