Medical Devices News and Research

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CardioTech receives approval for a second graft size for CardioPass clinical trial

CardioTech International, Inc., a developer and manufacturer of advanced medical devices and materials for the treatment of a broad range of disease states, today announced that it has received the necessary Ministry of Health approval to add a 4mm graft for the clinical trial of CardioPass , the Company's proprietary synthetic coronary bypass graft. Until now, the trial was only approved for a 5mm graft.

7 May 2008

Results of St. Jude Medical deep brain stimulation study presented at APA meeting

St. Jude Medical, Inc. today announced pilot study results from the first multi-center study investigating deep brain stimulation (DBS) of Brodmann Area 25 for major depressive disorder.

5 May 2008

New surgical device earns high marks from combat surgeons

Results of an independent clinical study conducted by U.S. Army combat support surgeons in Baghdad show that a new medical device used to close a type of surgical wound more quickly is saving lives and limbs of soldiers and civilians.

2 May 2008

FDA begins multi-year hiring initiative

Biologists, chemists, medical officers, mathematical statisticians and investigators are among the experts in demand as the U.S. Food and Drug Administration begins a multi-year hiring initiative.

30 Apr 2008

Medical schools should implement bans on pharmaceutical, medical device industry gifts, editorial states

A report released on Sunday by a task force of the Association of American Medical Colleges that recommends new restrictions on what physicians, staff members and students at U.S. medical schools can accept from drug companies and medical device makers is "encouraging," but it "flinched" on some important issues, a New York Times editorial states (New York Times, 4/29).

29 Apr 2008

Association of American Medical Colleges proposes ban on 'pharma' gifts to physicians, staff, medical students

All 129 U.S. medical schools should not allow pharmaceutical and medical device companies to provide food, gifts and travel to physicians, faculty members and students, according to a report released on Sunday by the Association of American Medical Colleges, the New York Times reports.

28 Apr 2008

Wireless technology needed to build recession proof health services

Healthcare providers are increasingly using wireless technology to minimise the cost and disruption associated with the deployment of innovative ehealth and telecare services.

23 Apr 2008

Signalife awarded new U.S. patent for method to monitor heartbeats

Signalife, Inc. has announced that the United States Patent and Trademark Office has awarded the Company a new and important patent entitled "System For, And Method Of, Monitoring Heartbeats Of A Patient". The patent, which covers 37 claims, will enhance the Company's ability to develop new proprietary products.

23 Apr 2008

FDA approves guayule latex gloves

The U.S. Food and Drug Administration has cleared for marketing the first device made from a new form of natural rubber latex, guayule latex. The product, the Yulex Patient Examination Glove, is derived from the guayule bush, a desert plant native to the Southwestern United States.

23 Apr 2008

New York Times examines opposition to proposed off-label promotion guidelines amid allegations of ghostwriting

The New York Times on Saturday examined how a recent report indicating that Merck used "ghostwriters" to produce medical journal articles in support of the COX-2 inhibitor Vioxx "has galvanized opponents to a federal proposal that would relax some restrictions on drug promotion" in the U.S.

21 Apr 2008

Draft legislation aimed at overhauling FDA would require more inspections, change user fees

House Energy and Commerce Committee Chair John Dingell (D-Mich.) on Thursday released draft legislation that would make broad regulatory changes to FDA and increase funds for the agency, CQ Today reports.

18 Apr 2008

VNUS Medical Technologies receives 'notice of allowability' for endovenous laser products patents

VNUS Medical Technologies, Inc. has announced that the company has received a Notice of Allowability by the U.S. Patent & Trademark Office for a patent application that is a continuation of one of the three patents in the VNUS patent infringement lawsuit against suppliers of endovenous laser products.

18 Apr 2008

Angiotech receives FDA clearance to market 5-Fluorouracil-coated central venous catheter

Angiotech Pharmaceuticals, Inc. has announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its innovative 5-Fluorouracil-coated (5-FU) Central Venous Catheter (CVC) in the United States.

17 Apr 2008

FDA approves expansion of NeoVista's phase 3 study for wet AMD

NeoVista, Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted the company's request to expand the number of sites participating in its pivotal Phase 3 trial from 10 to 30 in the United States.

17 Apr 2008

American Chemistry Council calls on FDA to update review of Bisphenol A

The American Chemistry Council (ACC) today sent a letter to FDA Commissioner Andrew von Eschenbach requesting FDA to update its review of the safety of bisphenol A in food contact applications.

17 Apr 2008

Warning about chemical found in plastic bottles and food containers

A chemical used to make plastic bottles and other food containers, is suspected to be linked to hormonal and neurological problems.

17 Apr 2008

NovoCure presents results from breast cancer pilot study

NovoCure announced today that it presented the results from a single-arm pilot trial evaluating the Novo-TTF, a non-invasive portable medical device, combined with neo-adjuvant chemotherapy for the treatment of patients with locally advanced breast cancer.

15 Apr 2008

Appendix removed through a patient's vagina

On March 26, 2008, surgeons at UC San Diego Medical Center removed an inflamed appendix through a patient's vagina, a first in the United States.

From Evident Corporation - Life Sciences 31 Mar 2008

FDA makes recommendations on medical devices that treat blocked heart arteries

U.S. Food and Drug Administration Commissioner Andrew C. von Eschenbach has announced that the agency has issued draft guidelines to aid the development, testing and manufacture of coronary drug-eluting stents, devices used to treat blocked heart arteries.

28 Mar 2008

Physical therapy helps symptoms of urinary incontinence in women

A study published in the Annals of Internal Medicine (March 18, 2008) reports that pelvic floor muscle training, in conjunction with bladder training, resolved the symptoms of urinary incontinence in women.

20 Mar 2008

Medical Devices News and Research

CardioTech receives approval for a second graft size for CardioPass clinical trial

Results of St. Jude Medical deep brain stimulation study presented at APA meeting

New surgical device earns high marks from combat surgeons

FDA begins multi-year hiring initiative

Medical schools should implement bans on pharmaceutical, medical device industry gifts, editorial states

Association of American Medical Colleges proposes ban on 'pharma' gifts to physicians, staff, medical students

Wireless technology needed to build recession proof health services

Signalife awarded new U.S. patent for method to monitor heartbeats

FDA approves guayule latex gloves

New York Times examines opposition to proposed off-label promotion guidelines amid allegations of ghostwriting

Draft legislation aimed at overhauling FDA would require more inspections, change user fees

VNUS Medical Technologies receives 'notice of allowability' for endovenous laser products patents

Angiotech receives FDA clearance to market 5-Fluorouracil-coated central venous catheter

FDA approves expansion of NeoVista's phase 3 study for wet AMD

American Chemistry Council calls on FDA to update review of Bisphenol A

Warning about chemical found in plastic bottles and food containers

NovoCure presents results from breast cancer pilot study

Appendix removed through a patient's vagina

FDA makes recommendations on medical devices that treat blocked heart arteries

Physical therapy helps symptoms of urinary incontinence in women

Sensing a Healthier Future

Achieving and maintaining ISO/IEC 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

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