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The Lead

Infographic: Outsourcing in the Development of Medical Devices

December 17, 2014 10:11 am | by Eileen Whitmore, Art Director, and Sean Fenske, Editor-in-Chief | News | Comments

MDT sent out a survey to readers focused on their experience with outsourcing in the development of medical devices. The following infographic reflects their responses to a number of questions related to the topic. For additional insight...

What Do You Mean You Aren’t Outsourcing?

December 17, 2014 10:07 am | by Sean Fenske, Editor-in-Chief | Blogs | Comments

When I started covering this industry more than 15 years ago, using outsourcing service...

MedTech Engineer Specializes in Sophisticated Medicine

December 16, 2014 11:35 am | by Leda Zimmerman, MIT Spectrum | News | Comments

Bhatia’s research defies traditional academic categories, drawing simultaneously on biological...

FDA Clears Blood Test that Predicts Heart Disease Risk

December 16, 2014 10:38 am | by FDA | News | Comments

The U.S. Food and Drug Administration today cleared a new screening test that predicts a patient...

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Optical Technology Diagnoses Brain Damage from Concussions, Strokes and Dementia

December 15, 2014 2:05 pm | by Tufts University | News | Comments

New optical diagnostic technology developed at Tufts University School of Engineering promises new ways to identify and monitor brain damage resulting from traumatic injury, stroke or vascular dementia--in real time and without invasive procedures...

Non-Invasive Imaging Tech Detects Cervical Cancer

December 15, 2014 11:53 am | by American Institute of Physics (AIP) | News | Comments

Cervical cancer is, in many ways, a shining example of how successful the war on cancer can be. Thanks largely to the advent of Pap smear screening, U.S. cervical cancer deaths decreased dramatically, by more than 60 percent, between 1955 and 1992...

Innovative Technologies for DNA Diagnostics and Health Monitoring

December 15, 2014 11:13 am | by Mina Rais-Zadeh, IEDM 2014 Focus Session Chair, Associate Professor, University of Michigan | Blogs | Comments

Several papers on advanced medical electronics technology will be presented at the IEEE International Electron Devices Meeting (IEDM) in San Francisco on Dec. 15-17, including bio-MEMS, bio-sensors, and technology for DNA diagnostics and...

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Battle Lines Being Drawn Over LDT Regulation

December 15, 2014 9:54 am | by Richard Park, Contributing Editor | Blogs | Comments

“The heart of Bradley Thompson’s argument rests on, ‘if a company is manufacturing an IVD test, the agency has full authority.’ Developing and performing most LDTs is not ‘manufacturing’ in a recognized sense of the word and never has been (although...

Nucleosomics Epigenetic Blood Tests to Revolutionize Cancer Detection

December 12, 2014 11:23 am | by Jake Micallef, VolitionRx | Articles | Comments

Cancer, which touches the lives of many, has remained a leading cause of death in the United States. While most cancers are treatable if caught before it has become locally invasive and has spread through the body, many cancers are not diagnosed...

Mobile Vital Signs Monitoring Devices Will Revolutionize Healthcare

December 12, 2014 8:00 am | by Sean Fenske, Editor-in-Chief | Analog Devices, Inc. | Blogs | Comments

Over the next five years, we are likely to see vital signs monitoring as a universal facet of everyday life. The sensing will be discreet, convenient, and painless. Expert systems will sit quietly in the background and occasionally rear their head to warn...

Engineering with a Side of Origami

December 11, 2014 10:44 am | by University of Pennsylvania | News | Comments

Origami is capable of turning a simple sheet of paper into a pretty paper crane, but the principles behind the paper-folding art can also be applied to making a microfluidic device for a blood test, or for storing a satellite’s solar panel in a rocket’s cargo bay...  

New Technology Tracks Carcinogens as They Move through the Body

December 11, 2014 9:40 am | by Oregon State University | News | Comments

Researchers for the first time have developed a method to track through the human body the movement of polycyclic aromatic hydrocarbons, or PAHs, as extraordinarily tiny amounts of these potential carcinogens are biologically processed and eliminated...

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Prototype Point-of-Care Analyzer Enables Early Ebola Detection

December 10, 2014 12:16 pm | by STMicroelectronics | News | Comments

Driven by the ambitious objective to quickly detect the Ebola virus in the blood at a very early stage to minimize further transmission, STMicroelectronics and Clonit, in collaboration with Italy’s National Institute for Infectious Diseases Lazzaro Spallanzani...

The Pulse: Pain-Free Lancing for Blood Testing and Tracking Surgeons’ Eyes

December 10, 2014 11:36 am | by John Dipierro, Multimedia Production Specialist | Videos | Comments

On this episode of the Pulse, we’re performing a blood draw pain-free, comparing heart vital signs, tracking the eyes of surgeons, and giving the disabled access to smartphones.           

Integrating Patient Devices into Health IT Systems

December 10, 2014 11:20 am | by Charles Settles, Product Analyst, TechnologyAdvice | Articles | Comments

The launch of Apple’s HealthKit platform was the first real sign the fitness and health tracking movement had legs; Apple has always been intentional about its moves, and its fans are usually quick to adopt new offerings. They’ve already announced...

Easing the Burden on Healthcare Professionals

December 10, 2014 7:30 am | by Jan Wittenber, Member of IEEE and Fellow at the Center for Medical Interoperability | Blogs | Comments

The following from the Background section of the ISO/IEEE 11073 Personal Health Data (PHD) Standards addresses this topic appropriately: “Demographics changes (the rapidly aging population in many industrialized countries) and an increase...

Blood Test for Breast Cancer

December 9, 2014 11:56 am | by Oxford University | News | Comments

It may be possible to develop a simple blood test that, by detecting changes in the zinc in our bodies, could help to diagnose breast cancer early. A team, led by Oxford University scientists, took techniques normally used to analyze trace metal...

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Crowdsourcing for Solutions to Epileptic Seizure Detection and Prediction

December 9, 2014 10:20 am | by American Epilepsy Society (AES) | News | Comments

An international competition using the wisdom of crowds has developed computer algorithms to detect, predict, and ultimately prevent epileptic seizures. A total of five-hundred and four teams competed in two challenges, one for Seizure Detection...

Home (Healthcare) Is Where the Need Is

December 9, 2014 7:30 am | by Carlos Castillo, Biomedical Engineer & Research Biomedical Engineering Advisor, Loma Linda University Zhang Neuroscience Laboratory | Blogs | Comments

Short answer, where the need is! Perhaps numbers will make this more clear. Sen. Rob Portman (R-Ohio) gives us the first part of this equation “Each day, 10,000 baby boomers retire and begin receiving Medicare and Social Security benefits”... 

Rapid Ebola Test Runs Off Car Battery for Remote Locations

December 8, 2014 12:28 pm | by Rutgers University | News | Comments

Rutgers researcher David Alland, working with the California biotechnology company Cepheid, has received a grant of nearly $640,000 from the National Institutes of Health to develop a rapid test to diagnose Ebola as well as other viruses that can...

Medical Device Makers: You’re Responsible for Device Cybersecurity

December 8, 2014 11:06 am | by AAMI | News | Comments

Who is responsible for the cybersecurity of medical devices? The makers of those devices. That anyway is the position of the American Hospital Association (AHA), which made its point in comments submitted to the U.S. Food and Drug Administration...

IVD Companies Join Ebola Fight

December 8, 2014 9:58 am | by Richard Park, Contributing Editor | Blogs | Comments

While the initial hysteria and fear of an Ebola pandemic has quieted down, the fight against this disease is far from over. National Public Radio reported that there were 537 new Ebola infections in Sierra Leone in one week, which is the largest weekly...

Friday 5: Connecting Healthcare with TE Connectivity's Thomas Medina

December 5, 2014 9:42 am | by Sean Fenske, Editor-in-Chief | Blogs | Comments

I foresee a continuous transition from body-worn to body-integrated devices designed to deliver very specific, customized care. Device function will be monitored and controlled remotely, determined via gene-based diagnosis and therapies; and will be...

World’s Fastest 2-D Camera May Enable New Scientific Discoveries

December 3, 2014 1:55 pm | by Tony Fitzpatrick, Washington University in St. Louis | News | Comments

A team of biomedical engineers at Washington University in St. Louis, led by Lihong Wang, PhD, the Gene K. Beare Distinguished Professor of Biomedical Engineering, has developed the world’s fastest receive-only 2-D camera, a device that can capture...

3 Questions: Lee Gehrke on a New Paper Diagnostic for Ebola

December 3, 2014 12:16 pm | by Anne Trafton, MIT News Office | News | Comments

Once a patient infected with the Ebola hemorrhagic virus starts showing symptoms, it can take several hours under the best conditions, and up to several days in remote areas, to get diagnostic results using conventional tests, such as identification...

Brain Representations of Social Thoughts Accurately Predict Autism Diagnosis

December 3, 2014 11:37 am | by Carnegie Mellon University | News | Comments

Psychiatric disorders — including autism — are characterized and diagnosed based on a clinical assessment of verbal and physical behavior. However, brain imaging and cognitive neuroscience are poised to provide a powerful advanced new tool...

Green Light from FDA for CT Lung-Imaging Software

December 3, 2014 11:08 am | by University of Michigan Health System | News | Comments

A technology that started in a University of Michigan Medical School lab may soon help lung disease patients around the world breathe a little easier, by helping their doctors make a clearer diagnosis and more individualized treatment plan. Imbio...

Novel Nanoparticle Technology to Be Used to Screen for Ebola Virus in Saliva

December 3, 2014 10:53 am | by George Mason University | News | Comments

Ceres Nanosciences Inc. (Ceres) today announced the commencement of a development program, funded by the Gates Foundation, to use Ceres' Nanotrap particle technology to develop a new method of detecting the presence of the Ebola virus in saliva...

Sale of Three Siemens Healthcare Units Raises Questions About Firm’s IVD Future

December 3, 2014 10:41 am | by Kalorama Information | News | Comments

The announced sales of three healthcare units within Siemens Healthcare may indicate the company is looking to expand in non-healthcare areas, says Kalorama Information. Siemens hasn’t announced any further sales. The healthcare market research...

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