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Sunshine Heart awarded $2.15m grant to support development of heart assist device

Sunshine Heart, Inc., today announced it has been awarded a second Commercial Ready Grant (CRG) from the Australian Government to help fund further development of its revolutionary C-Pulse heart assist device.

21 Sep 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

MIT device to detect and prevent epileptic seizures

Epilepsy affects about 50 million people worldwide, and while anticonvulsant medications can reduce the frequency of seizures, the drugs are ineffective for as many as one in three patients.

12 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

New device may reduce complications during heart surgery

Recycling of fat-contaminated blood from the wound during heart surgery, is suspected to contribute to enhance the risk of post-surgical brain damage.

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

First drug-eluting stent approved in Europe for most severe form of arterial disease in the leg

Cordis Endovascular, a division of Cordis Corporation, announced today that the Cypher Select Sirolimus-eluting stent received CE (Communite European) Mark in Europe for use in the treatment of severe claudication and critical limb ischemia (CLI) of infrapopliteal lesions, which is the most severe form of arterial disease in the leg.

6 Sep 2006

FDA approves limited use of artificial heart

The Food and Drug Administration (FDA) in the United States has given approval for limited use of an artificial heart.

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

New York Times examines debate over preimplantation genetic diagnosis

The New York Times on Sunday examined the debate over preimplantation genetic diagnosis, a technique that allows physicians to identify embryos without genetic defects or chromosomal abnormalities and then implant the embryos most likely to result in a live, healthy infant.

5 Sep 2006

New microfluidic device suitable for large-scale screening of disease-related biomarkers

Researchers at the Virginia Bioinformatics Institute (VBI) at Virginia Tech have developed a disposable microchip that replaces space-consuming instrumentation with fast, cost-effective, lab-on-a-chip technology.

5 Sep 2006

New technology can help a tired heart

World Congress of Cardiology Report - We have shown that it is possible to care for ill patients affected by heart failure directly from home by controlling their heart rate, fluid retention, blood pressure and weight through new telemedicine techniques.

5 Sep 2006

Record your electrocardiogram wearing a shirt

World Congress of Cardiology Report - A shirt capable of recording the electrocardiogram (electrical activity of the heart) has been developed and tested in a European research project (WEALTHY, Wearable Health Care System), funded by the European Community.

5 Sep 2006

Edible coatings will be the packaging of the future

The growing demand by consumers for healthier and more ecological foods has driven researchers to develop new systems of packaging that prolong the useful life of the products and that are, at the same time, recyclable.

4 Sep 2006

Bang & Olufsen Medicom and AstraZeneca to develop new patient monitor that measures patient compliance

Bang & Olufsen Medicom has announced that it has entered into an agreement with AstraZeneca on the development of a new patient monitor that measures patient compliance.

4 Sep 2006

Hopkins develops online tool to aid research on certain "orphan diseases"

Many people are afflicted with rare illnesses of unknown cause, and finding a common link to such under-studied or "orphaned" diseases as Bardet-Biedl, Alstrom and Meckel-Gruber syndromes can significantly advance the search for causes and treatment.

31 Aug 2006

New device helps people with tunnel vision

Scientists at Schepens Eye Research Institute, an affiliate of Harvard Medical School, say a visual aid they invented promises to improve the visual abilities of people with tunnel vision.

31 Aug 2006

Mitochondrial DNA sequencing tool updated

High-tech laboratory tools, like computers, are often updated publicly as their analytical capabilities expand. In the September issue of the Journal of Molecular Diagnostics, NIH grantees report they have developed a second generation "lab on a silicon chip" called the MitoChip v2.0 that for the first time rapidly and reliably sequences all mitochondrial DNA.

30 Aug 2006