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The Lead

Metal Injection Molding for Medical Device Manufacturers

August 27, 2014 10:57 am | by Becky Cater, MIM Product Manager, Proto Labs | Proto Labs, Inc. | Articles | Comments

Component fabrication for medical devices must often enable the manufacture of strong, durable parts in intricate shapes and designs. The ability to mold metal in an injection molding process moves developers much closer to this goal. The fact...

Solving a Customer's Problem

August 27, 2014 8:30 am | by Walter Hock, Director, Product Management, Portescap | Blogs | Comments

In today’s rapidly changing market, clinicians and aspiring entrepreneurs with an idea for a...

Photos of the Day: Picking Out Cancer Cells

August 26, 2014 11:10 am | by Anne Trafton, MIT News Office | News | Comments

Researchers from MIT, Pennsylvania State University, and Carnegie Mellon University have devised...

Risky Device MMAs Should Be Regulated

August 25, 2014 2:31 pm | by Steven G. Richter, Ph.D., President and Chief Scientific Officer, Microtest Laboratories Inc. | Blogs | Comments

I agree that the FDA should regulate mobile medical apps (MMA) because there is a potential that...

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Advances in Diabetes Drug Delivery

August 25, 2014 2:13 pm | by Zach Marks M.S. R.Ph., Director, Strategic Marketing, Delivery Systems, West Pharmaceutical Services Inc. | West Pharmaceutical Services, Inc. | Articles | Comments

Innovative drug delivery systems are a technology sector receiving increased interest for a number of reasons. One area seeing enhanced design solutions is the diabetes management space. Delivering the required insulin while being mindful...

Novel Pumping Technology Allows Precise Miniaturized Drug Delivery

August 22, 2014 2:53 pm | by Forrest Payne, Ph.D., Senior Scientist, SFC Fluidics Inc. | Articles | Comments

Developing an insulin-delivery technology that comes in a discreet package and suits the needs of diabetics can offer an array of design challenges. In this article, a company shares its experiences and obstacles to success while in the midst...

Photos of the Day: 3D-Printed Drug Delivering Implants

August 21, 2014 3:28 pm | by Louisiana Tech University | News | Comments

A team of researchers at Louisiana Tech University has developed an innovative method for using affordable, consumer-grade 3D printers and materials to fabricate custom medical implants that can contain antibacterial and chemotherapeutic...

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Photos of the Day: Space Robots Heal Kids

August 21, 2014 2:45 pm | by NASA | News | Comments

KidsArm is a robot that allows surgeons to quickly navigate to surgical sites in the body. It has an advanced imaging and control system that makes it extremely precise, and it is designed to explore the potential for automating certain...

Photos of the Day: Concussion Blood Test

August 18, 2014 9:59 am | by Abbott | News | Comments

Abbott's handheld, diagnostic analyzer is capable of performing a panel of commonly ordered blood tests on two or three drops of blood at the patient's side. Research suggests that certain proteins are released in the bloodstream following...

Payment Policy Challenges for Companion Diagnostics

August 18, 2014 9:26 am | by Richard Park, Contributing Editor | Blogs | Comments

The Personalized Medicine Coalition (PMC; Washington, DC) recently released a report calling for critical changes in payment and coverage policies for companion diagnostics, which would encourage innovation and improve the quality of healthcare...

Now Begins the Fight Over LDT Regulations

August 12, 2014 8:46 am | by Richard Park, Contributing Editor | Blogs | Comments

As IVD manufacturers and clinical laboratories gathered at the American Association for Clinical Chemistry's (AACC) annual meeting and clinical lab expo in Chicago, FDA made a major announcement that will likely test the relationship between...

Photos of the Day: Counterfeiting's Breathalyzer

August 7, 2014 4:45 pm | by University of Michigan | News | Comments

Terry Shyu, a doctoral student in chemical engineering at the University of Michigan, was demonstrating a new high-tech label for fighting drug counterfeiting. While the researchers don't envision movie stars on medicine bottles, but they...

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5 Steps that Speed EMC Testing

August 7, 2014 2:13 pm | by Bjarne Hansen, Electrical Engineer, StarFish Medical | Blogs | Comments

Electromagnetic interference (EMI) refers to unwanted effects in a medical device due to electromagnetic energy present in the environment. EMI can prevent proper operation of a medical device. For example, certain electric wheelchairs and...

The Pulse: Moving Fluids Across Open Surfaces and Visualizing the 3D Heart

August 7, 2014 11:54 am | by Jonathan Dipierro, Multimedia Production Specialist | Videos | Comments

On this episode of the Pulse, we’re moving fluids across active surfaces, visualizing a beating heart in 3D, preventing drowsy drivers, and getting a better night’s rest.             

Photos of the Day: Monitoring Disease Through Vapors

August 7, 2014 8:12 am | by University of Michigan | News | Comments

A new sensor, which can detect airborne chemicals either exhaled or released through the skin, would likely be the first wearable to pick up a broad array of chemical, rather than physical, attributes. U-M researchers are working with the National...

Photos of the Day: The Boy and the Bionic Hand

August 6, 2014 10:08 am | by GE Reports | News | Comments

Lyman Connor, a GE engineer who writes software for turbines and power plants, has always been a tinkerer. Among the tools in his garage is a 3D printer, which he decided to use to build a low-cost bionic hand. High-end electronic limbs use...

Photos of the Day: Bottling Ultrasound Imaging

August 5, 2014 11:08 am | by DOE/Lawrence Berkeley National Laboratory | News | Comments

Researchers with the U.S. Department of Energy (DOE)'s Lawrence Berkeley National Laboratory (Berkeley Lab) have developed a technique for generating acoustic bottles in open air that can bend the paths of sound waves along prescribed convex...

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Breaking Down the Regulation of LDTs: Moving Forward

August 4, 2014 3:29 pm | by Richard Park, Contributing Editor | Blogs | Comments

The letter stated that in order to move toward equal regulation, FDA should share its thinking on what it believes LDT regulation under FDCA should look like in practice, or how it plans to deregulate IVDs, by releasing its draft guidance...

The LDT Letter Battle

July 28, 2014 9:30 am | by Richard Park, Contributing Editor | Blogs | Comments

Earlier this month, five democratic U.S. Senators sent a letter to the Office of Management and Budget (OMB) regarding the regulation of laboratory-developed tests (LDT). In this letter, Senators Edward J. Markey (D-MA), Richard Blumenthal...

The Pulse: Reading Minds with Google Glass and Walking with Toyota

July 23, 2014 3:11 pm | by Jonathan Dipierro, Multimedia Production Specialist | Videos | Comments

This week on the Pulse, we’re using an open source app to read minds with Google Glass, using Toyota robots to help disabled people walk again, performing an endoscopy with a smartphone, and zinging around on a lightweight mobility chair...

10 Tips for Designing Medical Components with Aluminum

July 21, 2014 11:41 am | by Gordon Knott, Alexandria Industries | Articles | Comments

To better control the increasing product development costs without sacrificing quality, medical device OEMs are turning to aluminum instead of other more costly materials to manufacture both their new and existing components. The following...

Breaking Down the Regulation of LDTs: Access to Innovative IVDs

July 21, 2014 9:10 am | by Richard Park, Contributing Editor | Blogs | Comments

During the past few weeks, I’ve been reporting on a letter that Bradley M. Thompson, JD, and James A. Boiani, JD, attorneys at Epstein Becker Green, recently sent to FDA Commissioner Margaret Hamburg. The attorneys sent this letter on behalf...

Photos of the Day: Seven Fingers Are Better than Five

July 18, 2014 10:47 am | by MIT | News | Comments

Researchers at MIT have developed a robot that enhances the grasping motion of the human hand. The device, worn around one’s wrist, works essentially like two extra fingers adjacent to the pinky and thumb. A novel control algorithm enables...

Photos of the Day: Antimicrobial Clay

July 17, 2014 11:33 am | by National Science Foundation | News | Comments

Are the best medicines hidden in the Earth? French green clays are used for healing Buruli ulcers. Lynda Williams, a biogeochemist at Arizona State University and colleague Keith Morrison set out to identify naturally-occurring antibacterial...

Photos of the Day: Making a Mental Match

July 16, 2014 1:52 pm | by Georgia Institute of Technology | News | Comments

Georgia Tech has created a functional MRI-compatible rehab device for stroke patients that creates a long latency stretch reflex at the exact time as a brain signal. A pneumatic actuator tendon hammer hits a person's wrist while a transcranial...

Photos of the Day: Squishy Surgical Robots

July 14, 2014 12:12 pm | by MIT | News | Comments

Working with robotics company Boston Dynamics, the researchers began developing the material as part of the Chemical Robots program of the Defense Advanced Research Projects Agency (DARPA). The agency was interested in “squishy” robots...

Merck Committed to Companion Diagnostics

July 11, 2014 4:27 pm | by Richard Park, Contributing Editor | Blogs | Comments

During the past month and a half, pharmaceutical giant Merck has been actively forming partnerships with IVD manufacturers to develop companion diagnostics for their drugs. The following is a rundown of these recent alliances. At the end of...

Photos of the Day: Angry Birds, Robots, and Rehab

July 11, 2014 10:29 am | by Georgia Institute of Technology | News | Comments

A robot plays Angry Birds using a tablet. Researchers see their system as a future rehabilitation tool for children with cognitive and motor-skill disabilities. Kids teach the robot how to play Angry Birds, dragging their finger on the tablet...

Photos of the Day: Implant to Restore Memories

July 9, 2014 9:13 am | by Lawrence Livermore National Laboratory | News | Comments

Lawrence Livermore National Laboratory will develop an implantable neural device with the ability to record and stimulate neurons within the brain to help restore memory. The research builds on the understanding that memory is a process in which...

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