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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 | 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...

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From Wearables to Implantables to…What’s Next?

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

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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. | 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...

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Ramifications of UDI Requirements

October 7, 2014 8:30 am | by Craig Jones, VP Global Supports Services, PRISYM ID | 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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FDA Invents: How Technology Transfer Gets FDA Inventions from Lab to Marketplace

October 6, 2014 2:18 pm | by Alice Welch, Ph.D, Director — Technology Transfer Program, FDA | Comments

If you think the term “government invention” is an oxymoron — well, think again. You may be surprised to learn that many of the breakthrough technologies that shape our lives today are the brainchildren of government researchers — including those...

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Diagnosing Cancer with Yogurt

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

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Congress Tackles LDT Regulation: User Fees and FDA Resources

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

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Increase Efficiency by Combining Bioburden and Tests of Sterility

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

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Solution for 'Spin-Out' Success

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

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New Data Dashboard Tool Shares FDA’s Inspection, Compliance, and Recall Data

October 2, 2014 2:02 pm | by Douglas Stearn, Director of the Office of Enforcement and Import Operations, FDA | Comments

As part of our commitment to transparency FDA is pleased to announce that we have released a new online tool to provide insight into our compliance, inspection, and recall activities. This new dynamic tool represents a departure from the...

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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 | 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...

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FDA’s New Roadmap for Progress: Strategic Priorities 2014-2018

October 1, 2014 10:18 am | by Margaret A. Hamburg, M.D., Commissioner, FDA | Comments

The U.S. Food and Drug Administration regulates products that represent about 20 cents of every dollar American consumers spend on products. This includes the safety and effectiveness of drugs, medical devices, and vaccines, the safety of blood...

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Tighter Focus and Lower Costs

October 1, 2014 8:30 am | by Chetan N. Patel, President and Founder, SMC Ltd. | SMC, Ltd. | Comments

Obviously supply chain management is very important to contract manufacturing of any kind. With the amount of regulations and sub-tier supplier management needed, the OEM needs to be confident that the product being bought by the Contract...

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Thrilling Potential in 'Hitchcock Therapy'

September 30, 2014 9:16 am | by Sam Brusco, Editorial Intern | Comments

A shrouded man holding a gun stands in a dark room, breathing heavily, just behind the door. Your heart races and your whole body tenses as you silently (or often, vocally) beg the character about to enter the room, “Don’t go in there!” It's as if...

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Communicate Early and Often

September 30, 2014 8:30 am | by Trisha Mowry, CEO, Metal Craft | Comments

Engaging contract manufacturers as a partner allows each company to focus on core capabilities and best use of dollars and talent. Bringing on strategic partners to round out your supply chain with experts who are focused their specific...

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