Medical Devices News and Research

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Lab tests online to benefit Czech Republic

EDMA, the European Diagnostic Manufacturers Association is proud to announce that the multilingual website, Lab Tests Online is now also available in Czech. The website, an online encyclopaedia on laboratory testing and related conditions, has been developed in Czech by the Czech Society of Clinical Biochemistry, CSKB, in cooperation with the national and European Diagnostics industry associations, CZEDMA and EDMA.

14 Oct 2008

MedPAC hearing panelists call for residency programs to move away from hospital-centered care, toward treatment of chronic illnesses

Residency programs should place greater emphasis on the treatment of chronic diseases and on incorporating health information technology because current graduate medical education focuses too heavily on hospital-centered care, panelists told the Medicare Payment Advisory Commission on Thursday, CQ HealthBeat reports.

5 Oct 2008

President Bush signs legislation to expand protections under Americans with disabilities act

President Bush on Thursday signed legislation that expands protections under the Americans with Disability Act, the AP/Kansas City Star reports (AP/Kansas City Star, 9/25).

29 Sep 2008

Supreme Court prepares to hear pre-emption case that could give pharmaceutical companies protection against liability

The case of a Vermont women who won a $6 million award from Wyeth for failure to adequately warn her of the risk of one of its products is the "latest in a brisk parade of similar ones" in which the U.S. Supreme Court will examine the principle of pre-emption, which states that FDA approval of drugs or medical devices pre-empts the ability for individuals to sue manufacturers for liability in state courts, the New York Times reports.

22 Sep 2008

Congress approves legislation that would expand Americans with Disabilities Act

The House on Wednesday gave final approval to Senate legislation (S 3406) expanding the definition of disability for people claiming discrimination under the Americans with Disabilities Act, the New York Times reports.

22 Sep 2008

Senate hearing discusses recommendations for increased regulations on direct-to-consumer ads for medical devices

Lawmakers and witnesses on Wednesday at a Senate Special Committee on Aging hearing discussed recommendations for increased regulations on direct-to-consumer advertisements for medical devices, Dow Jones reports (Corbett Dooren, Dow Jones, 9/17).

22 Sep 2008

Dollar-sized medical device provides injured military skydiver with pain relief

St. Jude Medical, Inc. today announced the first patient implant of an Eon Mini, the world's smallest, longest-lasting, rechargeable neurostimulator to treat chronic pain of the trunk or limbs and pain from failed back surgery.

17 Sep 2008

New research puts FDA under pressure over BPA

The results of a new study which has linked a chemical commonly used to make plastic containers, to human diseases, is adding to an already heated debate about he safety of such products.

17 Sep 2008

Senate approves bill to expand protections under Americans with disabilities act

The Senate on Thursday by voice vote approved a bill (S 3406) that would expand protections under the Americans with Disabilities Act, CongressDaily reports.

15 Sep 2008

Accelr8 announces publication of study on OptiChem bio-coatings

Accelr8 Technology Corporation announced today that two teams of university research collaborators report new methods for scalable production with the company’s patented OptiChem bio-coatings.

11 Sep 2008

ThermoGenesis announces distribution agreement for bone marrow stem cell device

ThermoGenesis Corp. announced today it has signed a distribution agreement with Celling Technologies for ThermoGenesis' MarrowXpress (MXP(TM)) product line used for isolating stem cells from bone marrow. The distribution rights are for the field of use in orthopedic intraoperative or point-of-care applications.

9 Sep 2008

Bacteria's sticky glue is clue to vaccine says scientist

Sticky glue secreted by the bacterium Staphylococcus aureus could be the clue scientists have been searching for to make an effective vaccine against MRSA, medical researchers heard today (Wednesday 10 September 2008) at the Society for General Microbiology's Autumn meeting being held this week at Trinity College, Dublin.

9 Sep 2008

Supreme Court to consider whether to bar liability lawsuits against pharmaceutical companies

The U.S. Supreme Court in November will consider whether to shield the makers of prescription and over-the-counter drugs from liability lawsuits, the Los Angeles Times reports.

9 Sep 2008

New coating for urinary catheters reduce infection risk

A new coating for urinary catheters could reduce the risk of infection, according to research presented at the British Pharmaceutical Conference (BPC) in Manchester.

8 Sep 2008

A home early warning system for cardiac patients

Heart disease is the number one cause of death in Europe and early diagnosis is essential to save lives. Monitoring the heart's rhythm and electrical activity in real time using an electrocardiogram (ECG) provides vital information about abnormalities and gives clues to the nature of a problem. Some cardiac conditions need long-term monitoring - inconvenient for patients as it requires them to be away from their everyday environment for indeterminate periods of time.

3 Sep 2008

FDA clears non-invasive test to help manage heart transplant patients

The U.S. Food and Drug Administration has announced it has cleared for marketing a non-invasive test that uses molecular expression techniques to assist doctors in managing heart transplant patients post-surgery for potential organ rejection.

27 Aug 2008

Stanford University to limit pharmaceutical industry financing of CME

Stanford University officials on Tuesday plan to announce a new policy under which pharmaceutical and medical device companies no longer will have the ability to select continuing medical education courses that they seek to finance for physicians at the university's School of Medicine, the New York Times reports.

26 Aug 2008

Stanford Medical School severely restricts industry funding of continuing education for physicians

The Stanford University School of Medicine will no longer accept support from pharmaceutical or device companies for specific programs in continuing medical education, as industry-directed funding may compromise the integrity of these education programs for practicing physicians, officials said.

26 Aug 2008

FDA issues new rules on product warning label updates for pharmaceuticals, medical devices

FDA last week issued new rules that aim to ensure medication warning labels provide clear and concise information to consumers, the AP/Denver Post reports.

26 Aug 2008

Democrats opposing Supreme Court decision in favor of pre-emption pandering to tort lawyers, editorial says

The U.S. Supreme Court's "sensible" 8-1 ruling in the case of Reigel v. Medtronic, stating that medical devices approved by FDA are exempt from product liability lawsuits in state courts, "makes sense for many reasons" but has "nonetheless sent up yowls" from Democratic members of Congress who have proposed the Medical Device Safety Act (S 3398, HR 6381) to overturn the ruling, a Wall Street Journal editorial states.

13 Aug 2008

Medical Devices News and Research

Lab tests online to benefit Czech Republic

MedPAC hearing panelists call for residency programs to move away from hospital-centered care, toward treatment of chronic illnesses

President Bush signs legislation to expand protections under Americans with disabilities act

Supreme Court prepares to hear pre-emption case that could give pharmaceutical companies protection against liability

Congress approves legislation that would expand Americans with Disabilities Act

Senate hearing discusses recommendations for increased regulations on direct-to-consumer ads for medical devices

Dollar-sized medical device provides injured military skydiver with pain relief

New research puts FDA under pressure over BPA

Senate approves bill to expand protections under Americans with disabilities act

Accelr8 announces publication of study on OptiChem bio-coatings

ThermoGenesis announces distribution agreement for bone marrow stem cell device

Bacteria's sticky glue is clue to vaccine says scientist

Supreme Court to consider whether to bar liability lawsuits against pharmaceutical companies

New coating for urinary catheters reduce infection risk

A home early warning system for cardiac patients

FDA clears non-invasive test to help manage heart transplant patients

Stanford University to limit pharmaceutical industry financing of CME

Stanford Medical School severely restricts industry funding of continuing education for physicians

FDA issues new rules on product warning label updates for pharmaceuticals, medical devices

Democrats opposing Supreme Court decision in favor of pre-emption pandering to tort lawyers, editorial says

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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