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Healthcare Research and Development Institute reaches settlement with two State Attorneys General over alleged anticompetitive practices

The Florida-based Healthcare Research and Development Institute, a consulting group owned by about three dozen hospital executives, has agreed to no longer accept fees from companies that sell medications, medical devices and financial services to not-for-profit hospitals nationwide, according to a settlement reached on Wednesday with the Connecticut and Florida attorneys general, the New York Times reports.

29 Jan 2007

Coating characterisation of polymer-coated cardiovascular stents

Coating characterisation of polymer-coated cardiovascular stents has been undertaken utilising ToFSIMS, DSIMS and 3DP.

16 Jan 2007

Physical testing of coatings on medical devices and medical tubing

For over 25 years CSMA have provided analytical solutions to the medical device sector.

16 Jan 2007

Moog to acquire ZEVEX International

Moog Inc has announced that it has entered into a definitive agreement to acquire ZEVEX International, Inc for $13.00 in cash per share of ZEVEX common stock.

14 Jan 2007

Medicare begins to cover ultrasounds to detect aortic aneurysms

Medicare on Jan. 1 began to cover ultrasounds to detect abdominal aortic aneurysms in beneficiaries at high risk for the condition, the Charlotte Observer reports.

7 Jan 2007

CleveMed receives $2.3 million in funding for inpatient diagnosis of sleep disorders in cardiovascular surgery patients

Cleveland Medical Devices has announced that it has been awarded $2.3 M in NIH SBIR Phase II Continuation funding from the National Institute of Neurological Disorders and Stroke (NINDS).

7 Jan 2007

FDA advisory panel on drug-eluting stents to include physicians with industry ties

FDA will waive rules that prohibit advisory panel members from having financial ties to companies whose products are being reviewed to allow six physicians with ties to Johnson & Johnson and other heart device manufacturers to serve on a panel examining the possible health risks of drug-eluting stents, Bloomberg/South Florida Sun-Sentinel reports.

5 Dec 2006

CleveMed awarded $245,000 NIH grant to develop a device for quantifying the efficacy of alternative medicine techniques

Cleveland Medical Devices has announced that it has been awarded $245,000 in NIH SBIR funding.

2 Dec 2006

Some institutional review board members have ties to Rx, medical device firms

About 15% of institutional review board members, who are charged with deciding whether proposed clinical trials are ethical and safe, in the past year were asked to judge at least one proposal involving a drug or medical device company in which they have a financial stake or involving one of those company's competitors, according to a survey published in the New England Journal of Medicine

2 Dec 2006

No good reason to invest in new fetal oxygen monitor

New technology for measuring blood oxygen levels of a baby during labor which was intended to provide information useful for preventing birth complications, apparently offers no apparent benefit.

23 Nov 2006

FDA approves silicone gel-filled breast implants

After rigorous scientific review, the U.S. Food and Drug Administration (FDA) has approved the marketing of silicone gel-filled breast implants made by two companies for breast reconstruction in women of all ages and breast augmentation in women ages 22 and older.

19 Nov 2006

FDA to impose stricter medical device safety standards

FDA on Thursday released recommendations for improving post-market surveillance of medical devices, the AP/Los Angeles Times reports.

13 Nov 2006

FDA strengthens program for medical devices

The U.S. Food and Drug Administration (FDA) has announced its action plan for strengthening the way it monitors the safety of medical devices after they reach the marketplace.

13 Nov 2006

FDA warns about risks of using decorative contact lenses

This Halloween season, the U.S. Food and Drug Administration (FDA) is again warning consumers about the serious risks of using decorative contact lenses without the appropriate involvement of an eye care professional.

30 Oct 2006

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