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Cepheid Receives FDA Market Authorization for Xpert MTB/RIF

July 26, 2013 11:45 am | by Cepheid | News | Comments

Cepheid has announced that it has received market authorization from the U.S. Food & Drug Administration (FDA) for its Xpert MTB/RIF test. The review decision was based on the de novo 510(k) review process, which allows novel products without predicates to be down-classified and brought to market.

Cepheid Receives FDA Market Authorization for Xpert MTB/RIF

July 25, 2013 5:29 pm | by PR Newswire | News | Comments

Cepheid today announced it has received market authorization from the U.S. Food & Drug Administration (FDA) for its Xpert MTB/RIF test. The review decision was based on the de novo 510(k) review process, which allows novel products without predicates to be down-classified and brought to market.

Study in British Journal of Urology International Features a Practical Solution for MRI-Ultrasound Fusion to Enable Tumor-Targeted, Tissue-Preserving Prostate HIFU Treatment

July 25, 2013 2:16 pm | by The Associated Press | News | Comments

Study results published in the current issue of British Journal of Urology International (10.1111/bju.12223) demonstrate that new software to register and fuse information from magnetic resonance imaging (MRI) and ultrasound (US) images enables intraoperative visualization of tumors, not ordinarily seen in a US image.

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A Promising Test for Pancreatic Cancer ... From a Teenager

July 25, 2013 10:12 am | Videos | Comments

Over 85 percent of all pancreatic cancers are diagnosed late, when someone has less than two percent chance of survival. How could this be? Jack Andraka talks about how he developed a promising early detection test for pancreatic cancer that’s super cheap, effective and non-invasive -- all before his 16th birthday.

A Quick Test for the Black Death

July 24, 2013 11:54 am | by Max-Planck-Gesellschaft | News | Comments

Diagnosing the presence of Yersinia pestis, the cause of plague, may soon be easier than ever before. Scientists working with Peter Seeberger, Director at the Max Planck Institute of Colloids and Interfaces (MPIKG) in Potsdam and Professor at the Freie Universität Berlin, have come up with a simple, inexpensive and reliable method of detecting the bacterium.

‘Standards’ for Home Healthcare

July 23, 2013 4:44 pm | by Todd Konieczny, Assistant Chief Engineer, Americas Region; Technical Manager, Medical Division, Intertek | Blogs | Comments

The following standard must be met for all medical products intended to be used in the home: IEC 60601-1-11, which is “Medical Electrical Equipment—Part 1-11: General Requirements for Basic Safety and Essential Performance—Collateral Standard: Requirements for Medical Electrical Equipment and Medical Electrical Systems Used in the Home Healthcare Environment.”

Controlling Genes with Light

July 23, 2013 11:22 am | by Anne Trafton, MIT News Office | News | Comments

Although human cells have an estimated 20,000 genes, only a fraction of those are turned on at any given time, depending on the cell’s needs — which can change by the minute or hour. To find out what those genes are doing, researchers need tools that can manipulate their status on similarly short timescales.

The healthcare IT applications of Google Glass

July 23, 2013 8:29 am | by Mass Device | News | Comments

Last week I had the opportunity to test Google Glass. It's basically an Android smartphone (without the cellular transmitter) capable of running Android apps, built into a pair of glasses. The small prism "screen" displays video at half HD resolution.

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Zynex Signs Strategic Agreement With Advanced Brain Monitoring, Expands Presence in Sleep Diagnostic Market

July 22, 2013 8:00 am | by The Associated Press | News | Comments

Zynex, Inc. (OTCQB: ZYXI), a provider and developer of non-invasive medical devices for electrotherapy and stroke rehabilitation, neurological diagnostics and cardiac monitoring, announces that it signed a strategic sales, marketing and distribution agreement with California based Advanced Brain Monitoring.

Urine-based Cancer Detection Technology Validated

July 22, 2013 5:00 am | by The Associated Press | News | Comments

Trovagene, Inc. announces that results emerging from ongoing clinical studies have confirmed the broad applicability of Trovagene technology across a variety of cancer types, and the successful development of a molecular diagnostic test capable of detecting and quantifying oncogene mutations from a simple urine specimen.

The Search for the Best Depression Treatment

July 22, 2013 12:00 am | by Massachusetts Institute of Technology | News | Comments

When someone is diagnosed with depression, patient and doctor often begin a long trial-and-error of different treatments. Sometimes they work, sometimes they don’t, so patients may try several options before finding the best one. But in the future, a brain scan, blood test, or some combination could help guide doctors to the best drugs, or lead them to suggest talk therapy.

Gamma Medica closes $18M Series A round | Wall Street Beat

July 19, 2013 1:56 pm | by Mass Device | News | Comments

Gamma Medica said it's closed a $16 million Series A round from Psilos Group Managers. The Northridge, Calif.-based company said it plans to use the cash to expand the commercial footprint of its LumaGen molecular breast imaging device and the LumaGuide biopsy model.

TB Biosciences, Inc. Closes $1.5 Million in Series A Financing

July 18, 2013 9:56 am | by Business Wire | News | Comments

Tuberculosis has been all but eradicated in the United States, yet is a massive killer worldwide, especially in developing countries. Currently, over 90 million sputum tests are conducted annually. The sputum test is less than 50% accurate and unable to diagnose many with active tuberculosis.

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Abbott Labs Falls After Spinoff

July 17, 2013 1:20 pm | by The Associated Press | News | Comments

Abbott Laboratories Inc. said Wednesday that its net income fell in the second quarter following the spinoff of its branded drug business, but the results beat Wall Street expectations. Abbott sadi sales of nutrition and diagnostic products improved, making up for lower sales of generic drugs and medical devices.

Ensuring the Right Fit: Medical Device Testing and the Human Factor

July 16, 2013 2:12 pm | by Chris Evans, Director of Innovation—Pharmaceutical Delivery Systems, West Pharmaceutical Services | West Pharmaceutical Services, Inc. | Articles | Comments

Device testing is required for a wide array of variables in the development of a medical device. When it comes to devices used directly by the patient, however, it is critical to test the patient/device “relationship.” This article looks at examining and testing the human factor when it comes to the handling of a medical device and how the design can be improved to enhance that relationship.

Brain Wave Test Device for ADHD

July 16, 2013 9:51 am | by U.S. Food and Drug Administration | News | Comments

The U.S. Food and Drug Administration today allowed marketing of the first medical device based on brain function to help assess attention-deficit/hyperactivity disorder (ADHD) in children and adolescents 6 to 17 years old. When used as part of a complete medical and psychological examination, the device can help confirm an ADHD diagnosis.

Finding Cancer Cells in the Blood

July 16, 2013 12:00 am | by Massachusetts Institute of Technology | News | Comments

In the near future, oncologists may be using a finger-size plastic chip with tiny channels to extract a dozen or so cancer cells from a sample of a patient’s blood. Those cells, called circulating tumor cells, could then be screened for genetic disruptions that an oncologist could target with drugs best suited to attacking the tumor.

Commercial Release of 3D (Breast Tomosynthesis) Biopsy Option Strengthens Hologic's Position as Provider of the Nation's Most Comprehensive Portfolio of Interventional Breast Health Solutions

July 15, 2013 4:15 pm | by PR Newswire | News | Comments

Hologic, Inc., a leading developer, manufacturer and supplier of premium diagnostics products, medical imaging systems and surgical products, with an emphasis on serving the healthcare needs of women, recently expanded its extensive array of interventional and imaging solutions for breast health with the launch of the world's first 3D breast biopsy option.

The Power of LEDs Inside Medical Devices

July 15, 2013 3:12 pm | by Chuck DeMilo, Global Director of Product Marketing, Lighting Business Group, Luminus Devices | Articles | Comments

The medical device industry is constantly changing. New technologies and products enter the market, replacing outdated or inefficient equipment. There are numerous benefits in using LEDs for medical illumination applications including longer life, less heat, dynamic control, lower energy consumption, and in many cases, lower cost.

Welch Allyn Introduces Two Connectivity-Ready Electrocardiograph Devices

July 15, 2013 12:36 pm | by Welch Allyn | News | Comments

Welch Allyn, a leading medical diagnostic device company that specializes in helping clinicians improve patient outcomes, today announced the availability of two connectivity-ready electrocardiograph devices in the United States. The Welch Allyn CP 150™ offers flexible report formatting, intuitive design and functionality.

Welch Allyn Introduces Two Connectivity-Ready Electrocardiograph Devices in the United States

July 15, 2013 9:00 am | by Business Wire | News | Comments

Welch Allyn, a leading medical diagnostic device company that specializes in helping clinicians improve patient outcomes, today announced the availability of two connectivity-ready electrocardiograph devices in the United States. The Welch Allyn CP 150™ offers flexible report formatting, intuitive design and functionality.

Given Imaging's PillCam COLON Cleared in Japan, World's Second Largest Healthcare Market

July 14, 2013 10:45 pm | by GlobeNewswire | News | Comments

Given Imaging Ltd, a world leader in gastrointestinal medical devices and pioneer of capsule endoscopy, has announced that PillCam® COLON has been cleared by Japan's Pharmaceuticals & Medical Devices Agency for diagnosis of colonic disease when colonoscopy is required but difficult to conduct, including patients unwilling or unable to undergo colonoscopy.

Medical Industry and Chip Industry: Let’s Sum Up the Minds!

July 12, 2013 3:20 pm | by Liesbet Lagae, R&D Program Manager, Life Science Technologies, imec | Imec | Blogs | Comments

Imagine what could happen when medical and chip experts team up. Would it be possible for chips to revolutionize healthcare in the same way they have revolutionized the electronics industry? Let’s dream: a cheap technology that allows accurate and reliable diagnostics for everyone, at any place and at any time.

Wireless Mobile Technology Improves Patient Engament, Outcomes

July 12, 2013 12:02 pm | by Center for Connected Health | News | Comments

A recent study conducted by the Center for Connected Health demonstrated that wireless mobile technologies can positively impact patient engagement, clinical outcomes and operational workflow in remote monitoring programs. Patients using wireless mobile devices to collect and transmit their data to the Center's secure database more frequently measured their blood pressure and uploaded their data.

Daydreaming Simulated by Computer Model

July 12, 2013 10:00 am | by Michael C. Purdy, Washington University School of Medicine | News | Comments

Scientists have created a virtual model of the brain that daydreams like humans do. Researchers created the computer model based on the dynamics of brain cells and the many connections those cells make with their neighbors and with cells in other brain regions.

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