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Venture capitalists focus on medical device rules

As Congress considers reauthorizing a law that sets the fees for medical device makers, venture capitalists are emerging as a rich and influential ally of device companies eager to remove what they say are regulatory roadblocks in the approval process.

27 Oct 2011

CryoLife begins enrollment in BioFoam Surgical Matrix IDE clinical trial

CryoLife, Inc.,, a leading tissue processing and medical device Company focused on cardiac and vascular surgery, today announced that it has enrolled the first patient in its U.S. Investigational Device Exemption (IDE) clinical trial for its BioFoam® Surgical Matrix protein hydrogel technology. In connection with the trial, BioFoam will be used as an adjunct to conservative measures of achieving hemostasis on newly resected liver parenchyma.

24 Oct 2011

Zynex ranked 127th on Deloitte's 2011 Technology Fast 500 list

Zynex, Inc., a provider and developer of non-invasive medical devices for electrotherapy and stroke rehabilitation, neurological diagnosis and cardiac monitoring, announced that it has been ranked 127th on Deloitte's 2011 Technology Fast 500 list for revenue growth between 2006 and 2010.

24 Oct 2011

Encision second quarter total revenue increases 14% to $3.267 million

Encision Inc., a medical device company owning patented surgical technology that is emerging as a standard of care in minimally-invasive surgery, reported its financial results for its second fiscal quarter ended September 30, 2011.

24 Oct 2011

Potential deadly consequences of silicone injections

Reports of adverse events, including death, from silicone injections for cosmetic purposes have been increasing in both medical and consumer literature. In studies presented at CHEST 2011, the 77th annual meeting of the American College of Chest Physicians (ACCP), in Honolulu, Hawaii, researchers from Louisiana State University Health Sciences Center in New Orleans, Louisiana; Henry Ford Hospital in Detroit, Michigan; and Olive View-UCLA Medical Center in Sylmar, California all reported cases of near-lethal and lethal silicone use.

24 Oct 2011

X Prize Foundation offers $10 million for innovative diagnostic device

Jim, I'm a doctor, not a device developer! Remember how in Star Trek, Dr. McCoy could point his tricorder at things and magically - oops, I mean, "scientifically" - determine all kinds of chemical components and medical diagnoses? The X Prize Foundation - best known for offering prizes for space flight and cheap genome decoding - is about to put up $10 million for the invention of a medical device in the spirit of that tricorder: It must be able to diagnose 15 common medical conditions within three days, with no intervention from a health care professional.

22 Oct 2011

AAN recognizes six nurse informaticians with nursing fellowship

Six nurse informaticians, all leaders in the area of nursing known as nursing informatics, were inducted into the American Academy of Nursing (AAN) as Fellows, Saturday evening, Oct. 15, at the annual AAN Meeting and Conference.

22 Oct 2011

NPR: The Abbott Lab breakup

Abbott Labs is splitting up. The diversified maker of medical products will become two companies: one focused on brand-name prescription drugs and the second on the other stuff, including medical devices, diagnostic tests and baby formula.

21 Oct 2011

AMIA honors 4 leaders in biomedical and health informatics with Signature Awards

AMIA, the association for informatics professionals, honors four leaders in biomedical and health informatics with Signature Awards to be presented during AMIA's Annual Symposium, Oct. 22-26, an event expected to draw 2,500 informatics professionals to the Washington Hilton over the coming week.

21 Oct 2011

OncoSec submits Device Master File for OMS to FDA

OncoSec Medical Incorporated, which is developing its advanced-stage OMS ElectroOncology therapies for the treatment of solid tumor cancers, announced today the submission of its Device Master File (DMF) to the U.S. Food and Drug Administration (FDA) for its patented OncoSec Medical System (OMS) which consists of a generator and hand-held applicator.

20 Oct 2011

New prosthetic design may not offer same benefits for all knee replacement recipients

Undergoing a knee replacement involves sophisticated medical equipment, but innovative prosthetic design may not offer the same benefits for all knee replacement recipients, Yale School of Medicine researchers report in a perspective article in the October 20 issue of New England Journal of Medicine.

20 Oct 2011

New, more effective DBS paradigm may manage Parkinson's symptoms

Parkinson's disease (PD) is a devastating and incurable disease that causes abnormal poverty of movement, involuntary tremor, and lack of coordination. A technique called deep brain stimulation (DBS) is sometimes used to improve motor symptoms in patients with advanced disease. Now, a study published by Cell Press in the October 20 issue of the journal Neuron describes a new and more effective DBS paradigm that makes real-time adjustments in response to disease dynamics and progression and may be better for managing symptoms of advanced PD.

20 Oct 2011

Johnson & Johnson third quarter sales increase 6.8% to $16.0 billion

Johnson & Johnson today announced sales of $16.0 billion for the third quarter of 2011, an increase of 6.8% as compared to the third quarter of 2010. Operational results increased 2.6% and the positive impact of currency was 4.2%. Domestic sales declined 3.7%.

18 Oct 2011

St. Jude Medical commences use of renal denervation catheter and generator system

St. Jude Medical, Inc., a global medical device company, today announced the first use of the company's renal denervation catheter and generator system, as part of a feasibility study of the new technology. The technology was developed as a treatment for resistant hypertension (high blood pressure that is not well controlled by drug therapy).

18 Oct 2011

vRad announces premier radiology partnership with ICON

Virtual Radiologic (vRad), a technology-enabled national radiology practice, has announced a premier radiology partnership with ICON Medical Imaging (ICON), the medical imaging division of ICON plc.

18 Oct 2011

NEP successfully inserts specific doses of anti-cancer gene into leukemia cells

For the first time, researchers have found a way to inject a precise dose of a gene therapy agent directly into a single living cell without a needle.

18 Oct 2011

Most technoelectric dependent children not prepared for power failure

Children dependent on electrically powered medical devices for life support and maintenance are vulnerable to an unexpected loss of power - and their parents are ill-prepared to deal with it, according to an abstract presented Sunday, Oct. 16, at the American Academy of Pediatrics (AAP) National Conference and Exhibition in Boston.

18 Oct 2011

Laws may be modified for faster approvals of medical devices

Three U.S. senators seeking to speed up review times for medical devices have proposed two new bills for advisers to the Food and Drug Administration (FDA). The measure would reverse 2007 legislation that barred experts who had financial ties to a company or its competitor from serving on an advisory panel without a waiver. There is also a limit on the number of waivers that keeps decreasing.

16 Oct 2011

FDA approves PLC's U.S. pivotal trial of RenalGuard to prevent Contrast-Induced Nephropathy

PLC Systems Inc., a company focused on innovative medical device technologies, announced today that it has received final approval from the U.S. Food and Drug Administration to commence its U.S. pivotal trial to study the efficacy of the Company's RenalGuard Therapy and RenalGuard System in the prevention of Contrast-Induced Nephropathy.

14 Oct 2011

FDA's Circulatory System Devices Panel unanimously recommends Cook Medical's Zilver PTX Drug-Eluting Stent

The Zilver PTX Drug-Eluting Stent, the first device of its kind developed to treat peripheral artery disease (PAD) in the superficial femoral artery (SFA), has received a unanimous recommendation from the Food and Drug Administration's (FDA) Circulatory System Devices Panel of the Medical Devices Advisory Committee, Cook Medical announced today.

14 Oct 2011