MedWorm: Medical Equipment

Retained Surgical Items - Prevention System Created

Health News from Medical News Today — Wed, 08 Feb 2012 18:00:00 +0100

In order to avoid leaving surgical items, such as needles, sponges, retractors, blades and other items used during operations, in the body, surgical teams have relied on counting and recounting the items for decades. However, a new system using innovative technologies has been developed by the University of Michigan Health System. The new system reduces potentially serious medical errors, by ensuring that no foreign objects are accidently left in the patient's body during surgery. Ella Kazerooni, M.D., M.S... (Source: Health News from Medical News Today)

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Breathalyzer Device Identifies Glucose Metabolism Problems Accurately

Health News from Medical News Today — Wed, 08 Feb 2012 18:00:00 +0100

According to a study published in the peer-reviewed journal Metabolism, a "breathalyzer"-like technology, currently under development at the University of Wisconsin-Madison, may help diagnose diseases in the future. The study shows a simple, but sensitive technique, that can identify normal and disease-state glucose metabolism by a fast analysis of exhaled air or blood. Several diseases, including infections, diabetes, and cancer, change the body's metabolism in different ways... (Source: Health News from Medical News Today)

New IRS guidance sparks stepped-up calls for repeal of medical device tax

CMIO.net: The News Weekly for Health IT Executives — Wed, 08 Feb 2012 14:04:03 +0100

It was only Feb. 3 that the IRS released guidance for implementing the Patient Protection and Affordable Care Act’s 2.3 percent excise tax on manufacturers and importers of medical devices—due to kick in next January—but the action has already reignited a firestorm of protest. This will surprise no one who has followed industry’s anti-tax drumbeat, which began upon the release of a Sept. 2011 economic analysis forecasting the loss of 43,000 American jobs at the hands of the tax. (Source: CMIO.net: The News Weekly for Health IT Executives)

In Bone Repair, The Smallest Tools Could Give The Biggest Results

Health News from Medical News Today — Wed, 08 Feb 2012 09:00:00 +0100

When William Murphy works with some of the most powerful tools in biology, he thinks about making tools that can fit together. These constructions sound a bit like socket wrenches, which can be assembled to turn a half-inch nut in tight quarters, or to loosen a rusted-tight one-inch bolt using a very persuasive lever. The tools used by Murphy, an associate professor of biomedical engineering and orthopedics and rehabilitation at University of Wisconsin-Madison, however, are proteins, which are vastly more flexible than socket wrenches - and roughly 100 million times smaller... (Source: Health News from Medical News Today)

Early Signs Of Disease Detected By Metabolic 'Breathalyzer'

Health News from Medical News Today — Wed, 08 Feb 2012 09:00:00 +0100

The future of disease diagnosis may lie in a "breathalyzer"-like technology currently under development at the University of Wisconsin-Madison. New research published online in February in the peer-reviewed journal Metabolism demonstrates a simple but sensitive method that can distinguish normal and disease-state glucose metabolism by a quick assay of blood or exhaled air. Many diseases, including diabetes, cancer, and infections, alter the body's metabolism in distinctive ways... (Source: Health News from Medical News Today)

The Butterfly Effect In Nanotech Medical Diagnostics

Health News from Medical News Today — Wed, 08 Feb 2012 08:00:00 +0100

Tiny metallic nanoparticles that shimmer in the light like the scales on a butterfly's wing are set to become the color-change components of a revolutionary new approach to point-of-care medical diagnostics, according to a study published in International Journal of Design Engineering. Thomas Schalkhammer and colleagues at Attophotonics Biosciences GmbH in Austria are working with Roland Palkovits of the University of Applied Sciences, in Wiener Neustadt, to develop a nanoparticle microfluidic color device for medical diagnostics... (Source: Health News from Medical News Today)

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Meeting Materials for the Neurological Devices Panel meeting to be held on 2/10/12

Food and Drug Adminstration (FDA): CDRHNew — Wed, 08 Feb 2012 05:00:00 +0100

The Neurological Devices Panel reviews and evaluates data concerning the safety and effectiveness of marketed and investigational in vitro devices for use in clinical laboratory medicine including clinical and molecular genetics ... (Source: Food and Drug Adminstration (FDA): CDRHNew)

Pulmonx raises $10M

bizjournals.com Health Care:Physician Practices headlines — Tue, 07 Feb 2012 20:44:08 +0100

Pulmonx has raised $10 million, according to a regulatory with the U.S. Securities and Exchange Commission on Tuesday. The Redwood City-based company sold equity to raise the funds. It makes what it says are minimally invasive medical devices and technologies for diagnosing and treating pulmonary disorders. The filing lists the following related parties as directors: Howard Palefsky, Annette Campbell-White, Rich Ferrari, Rodney Perkins, Steve Salmon, Michael Baker, Staffan Lindstrand and Dana Mead... (Source: bizjournals.com Health Care:Physician Practices headlines)

CRT: FDA sheds light on percutaneous heart valve approval process

Cardiovascular Business News — Tue, 07 Feb 2012 09:01:07 +0100

WASHINGTON, D.C.—Sonna M. Patel-Raman, of the FDA’s Center for Devices and Radiological Health, explained the FDA application process for new medical devices, such as transcatheter heart valves, from pre-submission to investigational device exemption (IDE) to application submission during a Feb. 6 presentation at the Cardiovascular Research Technologies (CRT) meeting. (Source: Cardiovascular Business News)

Results From International Trial Of Second Sight's Argus II Retinal Prosthesis System Published In Ophthalmology

Medical Design Online News — Tue, 07 Feb 2012 09:00:00 +0100

Second Sight Medical Products, Inc., the world's leading developer of retinal prostheses for the blind, announced positive interim results from a single-arm, controlled, prospective, multicenter clinical trial of its Argus II Retinal Prosthesis (Source: Medical Design Online News)

Marken Enhances Presence In China

Medical Design Online News — Tue, 07 Feb 2012 08:19:00 +0100

Marken announced recently that it has recently received approval for its application for an expanded business license to allow the storage and distribution of clinical trial supplies and drug product in China. (Source: Medical Design Online News)

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Temple names director for translational medicine center

bizjournals.com Health Care:Biotechnology headlines — Mon, 06 Feb 2012 20:22:17 +0100

Temple University School of Medicine has recruited Walter Koch to serve as director of the university’s newly established center for translational medicine. Koch, who will also serve as a professor of pharmacology at the Temple medical school, was previously at Jefferson Medical College in Philadelphia where he was director of translational medicine and vice chairman of research. Translational medicine is a growing field dedicated to accelerating the process of turning biological discoveries into drugs and medical devices that can be used to treat patients... (Source: bizjournals.com Health Care:Biotechnology headlines)

Smith & Nephew to Settle Foreign Bribery Charges

WSJ.com: Health — Mon, 06 Feb 2012 19:50:02 +0100

Medical-device company Smith & Nephew and its U.S. unit will pay more than $22 million to settle charges that a former distributor bribed public doctors in Greece for more than a decade, the SEC said. (Source: WSJ.com: Health)

GAO: Implantable industry may be taking providers, payors for a ride on pricing

Cardiovascular Business News — Mon, 06 Feb 2012 15:06:56 +0100

The Government Accountability Office (GAO) has found that sellers of implantable medical devices are negotiating widely varying prices from different hospitals for the same devices and keeping their pricing strategies a secret. The lack of transparency may have major ramifications for Medicare, as hospitals with less purchasing power pass their costs along. (Source: Cardiovascular Business News)

Four priorities top FDA’s medical device to-do list for 2012

Cardiovascular Business News — Mon, 06 Feb 2012 13:35:35 +0100

Watch for the FDA’s Center for Devices & Radiological Health (CDRH) to focus attention on four areas of activity for the remainder of the current year: implementing a total product lifecycle approach, enhancing communication and transparency, strengthening its workforce and workplace, and facilitating innovation and addressing unmet public health needs. (Source: Cardiovascular Business News)

Bill Would Block FDA 510(k) Approval For Medical Devices Associated...

PRWeb: Medical Pharmaceuticals — Mon, 06 Feb 2012 06:00:14 +0100

Bernstein Liebhard reports on a newly introduced bill that would prevent medical device manufacturers from using the 510(k) process to receive FDA approval if they are predicated on previously...(PRWeb February 05, 2012)Read the full story at http://www.prweb.com/releases/vaginal-mesh-lawsuit/consumer-injury-lawyers/prweb9167102.htm (Source: PRWeb: Medical Pharmaceuticals)

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Public Workshop - Cardiovascular Metallic Implants: Corrosion, Surface Characterization, and Nickel Leaching, March 8-9, 2012

Food and Drug Adminstration (FDA): CDRHNew — Mon, 06 Feb 2012 05:00:00 +0100

The purpose of this workshop is to provide a forum for FDA, cardiovascular device manufacturers, test houses, and academia to discuss corrosion, surface characterization, and nickel leach testing, as well as collect comments and input regarding when... (Source: Food and Drug Adminstration (FDA): CDRHNew)

Federal Register: Cardiovascular Metallic Implants: Corrosion, Surface Characterization, and Nickel Leaching; Public Workshop

Food and Drug Adminstration (FDA): CDRHNew — Mon, 06 Feb 2012 05:00:00 +0100

The purpose of this public workshop is to provide a forum for FDA, cardiovascular device manufacturers, test houses, and academia to discuss corrosion, surface characterization, and nickel leach testing, as well as to collect comments and input... (Source: Food and Drug Adminstration (FDA): CDRHNew)

Federal Register: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Prominent and Conspicuous Mark of Manufacturers on Single-Use Devices

Food and Drug Adminstration (FDA): CDRHNew — Mon, 06 Feb 2012 05:00:00 +0100

The FDA is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. (Source: Food and Drug Adminstration (FDA): CDRHNew)

Fogarty Institute for Innovation launches advanced endovascular training fellowship

EurekAlert! - Medicine and Health — Mon, 06 Feb 2012 05:00:00 +0100

(WCG) The Fogarty Institute for Innovation announced today that it has launched its Advanced Endovascular Training Fellowship. This unique, year-long clinical training program for postgraduate physicians, which begins July 1, 2012, will provide Fellows with broad exposure to all aspects of endovascular patient care, with an emphasis on interventional training. Fellows will also engage with the Fogarty Institute's early-stage medical device start-up companies and assist in the process of developing technologies to improve patient care. (Source: EurekAlert! - Medicine and Health)

Heartbeat Vibrations Power Pacemakers

Health News from Medical News Today — Sat, 04 Feb 2012 08:00:00 +0100

Though pacemakers require only small amounts of energy (about 1 millionth of a Watt), their batteries have to be replaced periodically, which means multiple surgeries for patients. Researchers have searched for ways to prolong battery life - trying to generate energy to power a pacemaker using blood sugar, or the motion of the hands and legs - but these methods either interfere with metabolism or require a more drastic surgery, such as passing a wire from the limbs to the chest area... (Source: Health News from Medical News Today)

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Whistleblowers accuse FDA of spying, persecution

Chemistry World | Latest News — Fri, 03 Feb 2012 17:53:57 +0100

US FDA employees sue agency, saying they were subjected to secret surveillance for expressing safety concerns about medical devices (Source: Chemistry World | Latest News)

VeriTeQ Acquisition Corporation to offer implantable RFID Microchip

Healthcare IT News Press Releases — Fri, 03 Feb 2012 14:30:19 +0100

VeriTeQ Acquisition Corporation (“VeriTeQ” or “Company”), a leader in implantable, radio frequency identification (“RFID”) for humans and animals, announced today it will offer its FDA-cleared VeriChip microchip, a rice grain-sized, passive RFID microchip, for the identification of breast implants and other medical devices. VeriTeQ is already working to identify medical devices, specifically vascular ports, for the proper identification of the port and medication dosing requirements through an existing contract with a medical device manufacturer. read more (Source: Healthcare IT News Press Releases)

Molecules to Medicine: Plan B: The Tradition of Politics at the FDA

Scientific American - Official RSS Feed — Fri, 03 Feb 2012 12:39:00 +0100

Morning After The Morning's Trash In my last post , I focused on flaws in the medical device approval process. The Union of Concerned Scientists FDA at a Crossroads meeting also covered problems with drug approval. This is perhaps no better illustrated than by the disappointing decision by Secretary of Health Kathleen Sebelius to deny the emergency contraceptive, Plan B, over-the-counter status for women under the age of 17 . This was a particular disappointment to many because President Obama had promised that decisions at the FDA would be made based on science, rather than politics. Some of us, naively, hoped that change we can believe in was real, having forgotten that the Tooth Fairy wasn t. [More] (Source: Scientific American - Official RSS Feed)

Portable Recording Of Vital Signs Via "Life And Activity Monitor"

Health News from Medical News Today — Fri, 03 Feb 2012 09:00:00 +0100

Researchers have developed a type of wearable, non-invasive electronic device that can monitor vital signs such as heart rate and respiration at the same time it records a person's activity level, opening new opportunities for biomedical research, diagnostics and patient care. The device is just two inches wide, comfortable, does not have to be in direct contact with the skin and can operate for a week without needing to be recharged. Data can then be downloaded and assessed for whatever medical or research need is being addressed... (Source: Health News from Medical News Today)

Device Provides A Platform For Viewing Cancer Cells And Other Macromolecules In Dynamic, Life-Sustaining Liquid Environments

Health News from Medical News Today — Fri, 03 Feb 2012 09:00:00 +0100

A photograph of a polar bear in captivity, no matter how sharp the resolution, can never reveal as much about behavior as footage of that polar bear in its natural habitat. The behavior of cells and molecules can prove even more elusive. Limitations in biomedical imaging technologies have hampered attempts to understand cellular and molecular behavior, with biologists trying to envision dynamic processes through static snapshots... (Source: Health News from Medical News Today)

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Absorption Systems Expands In Vivo Drug and Medical Device Testing...

PRWeb: Medical Pharmaceuticals — Fri, 03 Feb 2012 06:24:02 +0100

Preclinical contract research organization renovates facility, adding state-of-the-art technology and upgrading ocular testing services.(PRWeb January 31, 2012)Read the full story at http://www.prweb.com/releases/2012/1/prweb9153045.htm (Source: PRWeb: Medical Pharmaceuticals)

Study: Hospitals Overpay for Devices

RWJF News Digest - Quality/Equality — Fri, 03 Feb 2012 05:00:00 +0100

Some hospitals pay thousands of dollars more than others for big-ticket medical devices such as defibrillators and hip replacements, and a portion of the higher costs could be passed on to the federal Medicare program, a new government report says. Note: Viewing this article may require a subscription. (Source: RWJF News Digest - Quality/Equality)

A New Color Correction Algorithm for Scanner Color Sensor