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Silicone breast implants make a comeback in Canada

The Canadian government has reversed a partial ban placed more than 13 years ago over health concerns linked to silicone breast implants.

23 Oct 2006

Calls for FDA to pay more attention to products made with nanotechnology

At a meeting called by the U.S. Food and Drug Administration (FDA), consumer and environmental groups have called for the FDA to pay more attention to products made by using nanotechnology.

11 Oct 2006

Uroplasty receives FDA approvable letter for treatment of female stress urinary incontinence

Uroplasty, Inc. has announced that it has received an approvable letter from the U.S. Food and Drug Administration (FDA) relating to its pre-market approval (PMA) application for Macroplastique Implants for the treatment of female stress urinary incontinence (SUI).

14 Sep 2006

New wireless internet technologies could reduce physician visits for patients with chronic diseases

The New York Times on Saturday examined new technologies that will allow tens of millions of U.S. residents with chronic diseases such as heart failure, diabetes and mental illnesses to have their conditions "constantly monitored, remotely and virtually, as they go about their daily lives."

11 Sep 2006

FDA releases draft guidelines regulating complex diagnostic tests

FDA on Tuesday released draft guidelines that assert the agency's authority for regulating gene- and protein-based diagnostic tests for conditions such as breast cancer and ovarian cancer, the Wall Street Journal reports.

6 Sep 2006

FDA provides guidance to industry for active ingredients used in medical tests

The U.S. Food and Drug Administration (FDA) today issued draft regulatory guidance for the medical device industry on commercially distributed active ingredients of medical tests called Analyte Specific Reagents (ASRs).

5 Sep 2006

FDA approves AbioCor permanent artificial heart for humanitarian uses

The U.S. Food and Drug Administration today approved the first totally implanted artificial heart for patients with advanced heart failure involving both pumping chambers of the heart under the Humanitarian Use Device (HUD) provisions of the Food, Drug and Cosmetic Act.

5 Sep 2006

FDA drafts new guidance to industry for group of medical tests

The U.S. Food and Drug Administration (FDA) today issued draft regulatory guidance for industry and clinical laboratories for a new type of medical test.

5 Sep 2006

FDA advisory panels almost always recommend approval for new drugs and devices

Eleven randomly selected FDA advisory committees recommended approval for 79% of prescription drugs and medical devices that they considered during a seven-year period, according to a study released on Monday by the National Research Center for Women & Families, Bloomberg/Houston Chronicle reports.

30 Aug 2006

Cook device improves kidney stone removal procedures

Cook Urological, a division of Cook, the world's largest private medical device company, is advancing the treatment of kidney stones with the 1.7 French NCompass Nitinol Stone Extractor.

15 Aug 2006

Arthrosurface launches new product for treatment of patello-femoral disease

Arthrosurface has received FDA clearance to launch its cartilage surface implant system for the treatment of patello-femoral disease.

15 Aug 2006

Recalls and safety alerts affecting automated external defibrillators

Automatic external defibrillators (AEDs) are important medical devices. Numerous studies have shown that thousands of lives are saved each year using these devices to treat patients in sudden cardiac arrest.

10 Aug 2006

FDA investigates use of identifier system for medical devices

The Food and Drug Administration (FDA) is seeking information on how the use of a unique identifier system for medical devices may reduce medical errors, facilitate device recalls and improve medical device adverse event reporting.

9 Aug 2006

Automated external defibrillators, reliability and clinical benefits

The FDA frequently issues safety advisories for automated external defibrillators and accessories, although the number of actual device malfunctions appears to be relatively small.

8 Aug 2006

UK recommendations on the availability of common painkillers are being contravened

In September 1998, UK legislation on pack sizes came into effect in a bid to curb the 200 odd deaths attributable to paracetamol poisoning every year in England and Wales.

2 Aug 2006

Doctors put their foot down over drug advertising

The American Medical Association (AMA), the largest doctors group in the U.S., has announced a new policy on the direct-to-consumer advertising of prescription drugs and implantable medical devices.

18 Jun 2006

A review of percutaneous kyphoplasty

A procedure that fills in fractured vertebrae with injected cement has not been shown to improve a person's back pain or quality of life, according to a new analysis of studies.

16 May 2006

Space technology to help hospitals contain spread of avian flu infection

In response to concerns from hospitals to prepare for eventual pandemic flu outbreaks, the French company AirInSpace, with support from ESA's Technology Transfer Programme, has successfully adapted technology developed to protect astronauts for use in critical care centres to protect immune-deficient patients against airborne pathogens such as the avian flu virus.

10 May 2006

New technology to help physicians and engineers pool resources to prevent stroke

A professor at the University of Houston and his research students are working with physicians and scientists at the Methodist Neurological Institute on new technology to help identify which brain aneurysms are at highest risk of rupture and could cause a stroke.

8 May 2006

New medical device improves blood pressure control

Physicians at the Hypertension and Vascular Disease Center at Wake Forest University Baptist Medical Center have proven that a new medical device improves blood pressure management in patients with the most common form of uncontrolled hypertension.

19 Apr 2006