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Regenerative Medicine: The Future Has Arrived

October 15, 2014 8:30 am | by David Green, CEO, Harvard Apparatus Regenerative Technology | Articles | Comments

Regenerative medicine is a quickly growing field that offers the potential to repair and replace damaged cells, tissue and organs. Although the field has shown rapid growth over the last decade, it still must overcome a series of hurdles before...

New York State: A Beacon for Bio/Med Growth

October 15, 2014 8:30 am | by Jessica Crawford, President, MedTech Association | Blogs | Comments

The Bio/Med Breakthroughs: Advancing New York’s Innovation Economy industry report by MedTech, the trade association for bioscience and medical technology (Bio/Med) companies in New York, which was launched at MEDTECH 2014, reveals a number...

For Medical Device Industry, Fewer Recalls but Further Complexity

October 14, 2014 8:30 am | by Mike Rozembajgier, Stericycle | Blogs | Comments

Product recalls happen daily across industries and geographies. While each recall event presents its own challenges, when a medical device is recalled the process involved in alerting consumers and retrieving product is quite complex. Recalls...

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Examining the Physician Office Lab Market: Growth and Reimbursement

October 13, 2014 2:49 pm | by Richard Park, Contributing Editor | Blogs | Comments

According to the report, the global market for physician office laboratory (POL) diagnostics was estimated at $2.4 billion in 2014. The U.S., Europe, and Japan represent 58%, 32%, and 5% of the market, respectively. The rest of the world accounts...

Gaming Through Clinical Trials

October 13, 2014 2:41 pm | by Sean Fenske, Editor-in-Chief | Blogs | Comments

Recently, I saw a news piece out of Carnegie Mellon University where researchers supported the use of “video game” style trials of life science hypotheses to prevent the instance of error and fraud. Massive online laboratories would be established...

5 Key Lessons to Successfully Prepare and Publish Data to the FDA’s GUDID

October 13, 2014 8:30 am | by Denise Odenkirk, Senior Director, Industry Solutions, GHX | Blogs | Comments

While the deadline for medical device companies to submit Class III product data to the FDA's Production Global UDI Database (GUDID) passed on September 24, 2014, the remaining 90 percent of all medical device implantables, as well as products...

Effectiveness of Low Dose CT Screening for Lung Cancer

October 13, 2014 8:30 am | by Jen Jenkinson | Articles | Comments

More people are diagnosed with lung cancer than any other malignancy around the world, with around 200,000 new diagnoses in the US each year1. Unfortunately, lung cancer has a poor survival rate, with about 150,000 deaths annually from the disease...

5 Things Engineers Regret About Their Careers

October 10, 2014 8:30 am | by Kasey Panetta, Managing Editor, ECN | Blogs | Comments

If only they knew then what they know now, who knows what would have happened? It’s a lamentable thought, but, short of the invention of some sort of time machine, the best engineers can do is offer their advice to the younger generation. It...

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IEEE Technology Time Machine Takes on the Future of Health

October 9, 2014 4:06 pm | by Bruce Wheeler, IEEE | Blogs | Comments

Innovation is driving a seemingly exponential growth of health-monitoring devices, many aimed at consumers with accuracy and reliability that falls far short of what is needed in the highly regulated healthcare market. Innovators need to be...

FDA Clearance: Are Your Mobile Applications Being Used for Diagnosis Without It?

October 9, 2014 8:30 am | by Pierre Lemire, President and CTO, Calgary Scientific | Blogs | Comments

On August 1st, the FDA released new rules that exempts many medical applications created for mobile devices from its regulatory scope. In general, the new rules are targeted at consumer applications and devices that the guidelines say are...

From Wearables to Implantables to…What’s Next?

October 8, 2014 9:39 am | by Sean Fenske, Editor-in-Chief | Blogs | Comments

Some time has passed since the Apple announcement of the company’s “iWatch” (at least as of the time I’m writing this) and all the pomp and circumstance that goes along with it. Unfortunately, from the mobile healthcare aspect, it was underwhelming...

Glucose Control - Both a Challenge and an Opportunity in MedTech

October 8, 2014 8:30 am | by Emily L. Cross, Ph.D, Director of Media and Communication, TecMed, Inc. | Blogs | Comments

In a 2009 educational presentation Dr. Alia Rizvi, a medical scholar-practitioner from the University Of South Carolina School Of Medicine reported that glucose control in the hospital, in-patient outcomes, and overall cost of patient care...

Ramifications of UDI Requirements

October 7, 2014 8:30 am | by Craig Jones, VP Global Supports Services, PRISYM ID | Blogs | Comments

The implications of product recall are well understood, and they serve as an operational driver for a change of approach. But there are regulatory maneuvers afoot too. The phased introduction of Unique Device Identification (UDI) requirements...

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Infographic: MedTech World Preview 2014

October 6, 2014 10:47 am | by Evaluate Ltd. | News | Comments

2014 marks a year of rapid change for the global medical device market, particularly within the cardiology and orthopedic spaces, which have been dominated by megamergers. If the deal between Covidien and Medtronic goes through, we could see...

Diagnosing Cancer with Yogurt

October 6, 2014 9:34 am | by Sean Fenske, Editor-in-Chief | Blogs | Comments

Even though I’m not personally a fan, even I’m aware of the many benefits yogurt offers. From improving your gut to potentially contributing to a lower blood pressure, perhaps a yogurt a day keeps the doctor away. But does it also keep the cancer...

Congress Tackles LDT Regulation: User Fees and FDA Resources

October 6, 2014 8:50 am | by Richard Park, Contributing Editor | Blogs | Comments

Last week, FDA finally released its two draft guidances on the regulation of laboratory-developed tests (LDT): Framework for Regulatory Oversight of LDTs and FDA Notification and Medical Device Reporting for LDTs. With the release of these...

Developing the Best Custom Positioning Solution for an Automated Pathology Scanner

October 6, 2014 8:30 am | by Jim Monnich, Engineering Manager – Electromechanical Positioning, and Brian Handerhan, Business Development Manager; Parker Hannifin | Articles | Comments

Digital pathology is a rapidly growing segment of in vitro diagnostics with the potential to streamline the overall pathology process for the benefit of both doctors and patients. This relatively new market segment requires motion systems...

Increase Efficiency by Combining Bioburden and Tests of Sterility

October 6, 2014 8:30 am | by Sean Shepherd, Sr. Study Director, Nelson Laboratories | Blogs | Comments

When it comes to radiation sterilization validation, there is a perception that the bioburden and sterility testing need to be conducted under separate submissions, with results from both then used to compile a statement report by the medical device...

Photos of the Day: Hearing with Google Glass

October 3, 2014 12:06 pm | by Georgia Institute of Technology | News | Comments

Captioning on Glass allows a person to speak into a phone. The text is then displayed on Glass. "Glass has its own microphone, but it's designed for the wearer," said Professor Thad Starner, who is also a technical lead for Glass. "The mobile...

6 'Connecting' Technologies that Impact Medical Devices

October 3, 2014 10:25 am | by Ohio University | News | Comments

While this infographic offers insights on connecting technologies that are serving people and communities, it isn't hard to see how they each have implications in the medical device space.             

Antimicrobial Additives in Medical Devices

October 3, 2014 8:30 am | by Lise Moloney, Director of Business Development, Healthcare Sciessent LLC | Articles | Comments

It is clear that progress is being made to reduce the number of healthcare acquired infections (HAIs) as stated in the recent progress report published by the Center for Disease Control and Prevention (CDC) this past March. However, we are...

Solution for 'Spin-Out' Success

October 3, 2014 8:30 am | by Dr. Daniel Burnett, CEO, TheraNova | Blogs | Comments

If I were to ask you to give me one word to define healthcare in the U.S, what would you say? I’m guessing “expensive” would be a leading response for many Americans, and they wouldn’t be wrong. Modern healthcare is costly due in part to the...

New Enhanced Properties for Bright 17-7 PH Stainless Steel

October 2, 2014 8:30 am | by Don Jordan, VP of Technology & Corporate Metallurgist, Solar Atmospheres, Inc. | Articles | Comments

17-7 PH is classified as a semiaustenitic stainless steel that has extensive use in aerospace and is finding new applications in the medical industry. The material is most often used in sheet and strip form, with springs, clips, and bellows...

5 Benefits of Best-Sourcing Medical Device Teams

October 2, 2014 8:30 am | by Martine Janicki PhD, PEng and a PMP, Project Manager for IHealth | Blogs | Comments

“Talent management is more than an operational practice, it is skilled art form. Human resources acquisition is the single most important area that will determine the design success or failure.” Best-Sourcing was coined by Tom Peters and...

Photos of the Day: Drug Injections via a Pill

October 1, 2014 11:43 am | by Massachusetts Institute of Technology | News | Comments

Researchers at MIT and Massachusetts General Hospital (MGH) have devised a novel drug capsule coated with tiny needles that can inject drugs directly into the lining of the stomach after the capsule is swallowed. When the pill reaches the desired...

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