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FDA-Approved 3D Breast CT Doesn't Require Tissue Compression

February 6, 2015 2:32 pm | by Koning Corporation | News | Comments

Koning Corporation, a leading developer of advanced medical imaging systems announced today that the FDA has approved their Koning Breast CT (KBCT) system and KBCT-guided biopsy bracket. This approval signals that KBCT has undergone and... 

FDA Head To Step Down, Chief Scientist Taking Over

February 6, 2015 9:41 am | by Matthew Perrone, Mary Clare Jalonick, The Associated Press | News | Comments

From food safety to tobacco and politically charged drug approvals, Margaret Hamburg reset the course of the embattled Food and Drug Administration, an agency that had often been seen as ineffective. After nearly six years on the job, Hamburg...

Ensuring Data Security and Best Practices for Home Healthcare

February 6, 2015 9:30 am | by Delmar Howard, mHealth Program Manager, Intertek | Blogs | Comments

Data security and patient privacy are top issues facing every medical device company operating in the mHealth landscape. Even with FDA’s recent Guidance on Management of Cybersecurity in Medical Devices, OEMS struggle with the necessary...  

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4 Important Security Concerns for Medical Devices

February 6, 2015 8:30 am | by Alan Grau, President, Icon Labs | Blogs | Comments

To meet FDA Guidelines for cyber security, medical device manufacturers need to design security into the device itself. Leveraging ecosystem partners with security expertise allows medical device OEMs to focus on their strengths while building...

The Elusive Search for Funding Continues into 2015

February 5, 2015 10:24 am | by Emily L. Cross, Ph.D. Director of Media and Communications, TecMed, Inc | Blogs | Comments

Leadership guru Peter Drucker is famously quoted as saying, “The best way to predict the future is to create it.” This is a powerful statement to the new, or experienced, entrepreneur who strives to change the face of the world, or at least a fragment...

Mobile Medical Apps: Recreational or Medical Devices?

February 5, 2015 9:50 am | by Seppo Vahasalo, Product Line Manager of Medical Devices, SGS Fimko Ltd, Finland | Articles | Comments

Today the trend in healthcare is ‘patient centric care model’. This is an addition to the previous five ‘P’s of modern healthcare: Prevention, Prediction, Personalization, Preemption and Personal Responsibility. The rise of smartphones as a...

Listening to Patients’ Views on New Treatments for Obesity

February 4, 2015 4:32 pm | by Jeffrey Shuren, M.D., J.D., Director, Kathryn O’Callaghan, Associate Director for Science and Strategic Partnerships; FDA’s Center for Devices and Radiological Health | Blogs | Comments

The world was a very different place in 1976, when the Food and Drug Administration launched its medical device program. Since Steve Jobs and Steve Wozniak were just that year launching a computer company called Apple, doctors weren’t yet able to...

Let's Not Make 'Precision Medicine' an IT Horror

February 4, 2015 3:49 pm | by Sam Brusco, Associate Editor | Blogs | Comments

About two weeks ago, during his State of the Union address, President Obama unveiled the initiative (with a $215 million budget) to fund “Precision Medicine”. He didn’t go into a huge amount of detail explaining it, but put simply...   

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KFx Medical Defends Patent for Reconstructive Surgery Procedure

February 4, 2015 3:34 pm | by Megan Crouse, Real Time Digital Reporter, Design Group | News | Comments

KFx Medical won a $35 million patent infringement case against Arthrex Inc. regarding three patents related to a procedure for anchoring soft tissue to bone in reconstructive surgery. KFx first filed a complaint against Arthrex in August of...

Obama Supports Tailored Approach to Medicine

February 4, 2015 12:20 pm | by Megan Crouse, Real Time Digital Reporter, Design Group | News | Comments

When people get blood transfusions, the blood is matched to their precise type. People who need glasses are given a prescription, not a generic pair. President Barack Obama has included in the 2016 federal budget $215 million to focus on Precision...

First FDA-Approved Tissue Adhesive for Internal Use

February 4, 2015 11:04 am | by U.S. Food and Drug Administration | News | Comments

The U.S. Food and Drug Administration (FDA) today approved TissuGlu, the first tissue adhesive approved for internal use. TissuGlu is a urethane-based adhesive that a surgeon can use to connect tissue flaps made during surgery to remove excess...

3 Likely Trends in MedTech in 2015

February 4, 2015 10:30 am | by John Smith, Partner, Hogan Lovells | Blogs | Comments

FDA’s premarket data requirements continue to increase, with a broader range of devices subject to clinical data requirements and expectations for pre-clinical data continuing to increase. The result has been a significant increase in the regulatory...

January/February 2015 Digital Edition

February 3, 2015 12:21 pm | by MDT Staff | Digital Editions | Comments
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Using Next-Generation Design Tools and Telling the FDA About It

February 3, 2015 11:17 am | by Arvind Ananthan, Medical Devices Industry Manager, MathWorks | Articles | Comments

Regulators and companies are in a constant tug of war, causing innovation in the medical device industry to be stifled. On one end, companies are feeling the effects of strong market pressure and customer demands to innovate only to run up...

Further UDI and MedWatch Regulation in 2015

February 3, 2015 8:49 am | by Deb Kacera, Regulatory & Industry Strategist, Pilgrim Quality Solutions | Pilgrim Quality Solutions | Blogs | Comments

In 2015, the medical device industry will be focused on meeting the regulations that support the speed and quality of capturing electronic information and the efficiency of sharing information. While 2014 saw the initiation of the Unique Device...

3 IVD Trends to Keep an Eye On In 2015

February 2, 2015 4:35 pm | by Kalorama Information | News | Comments

Kalorama Information says LDT regulation, new markets, and better sequencing tools are among the trends to watch in 2015. The healthcare market research firm specializes in in vitro diagnostic market forecasts and trends and said that 2015 may...

Drive to Repeal Medical Device Tax No Slam Dunk in Congress

February 2, 2015 12:51 pm | by Alan Fram, Associated Press | News | Comments

It flew through the Republican-run House in 2012, and a year later 79 of the Democratic-led Senate's 100 members embraced it. With Republicans now controlling both chambers of Congress, the chances for repealing the 2.3 percent tax on medical devices...

State Declares Electronic Cigarettes a Health Threat

January 30, 2015 10:51 am | by Fenit Nirappil, Associated Press | News | Comments

California health officials Wednesday declared electronic cigarettes a health threat that should be strictly regulated like tobacco products, joining other states and health advocates across the U.S. in seeking tighter controls as "vaping" grows in...

Mayo Clinic Expert Explains Telemedicine Benefits and Policy Changes

January 30, 2015 10:21 am | by Mayo Clinic | News | Comments

If you haven’t already experienced telemedicine, you may soon have the option. Technology is helping people connect with their physicians in new ways and from a distance, and interest is growing in updating state and federal policies to help...

Medical Device Tax Led To Thousands Of Job Cuts

January 30, 2015 10:11 am | by Andy Szal, Real Time Digital Reporter, Manufacturing.net | News | Comments

A recent survey conducted by a medical technology trade group blames a tax on medical devices for about 18,500 industry job cuts in the last two years. The Advanced Medical Technology Association said the tax -- which was enacted as part of...

Is Your New Mobile Health App Secure in 2015?

January 30, 2015 8:30 am | by David Surber, VP of Medical Products, TÜV Rheinland | Blogs | Comments

It is estimated that 500 million smartphone users worldwide will use healthcare applications in 2015 – from using the phone to detect glaucoma in the eye to taking cardiac measurements. The users include healthcare professionals, consumers, and...

Fitness Trackers, Other Wearables Not Subject to Regulatory Scrutiny

January 29, 2015 8:38 am | by AAMI | News | Comments

The U.S. Food and Drug Administration’s (FDA) device division has unveiled new draft guidance in which it reiterates that it does not intend to regulate low-risk general wellness products. The agency also tells manufacturers how they can...

Speeding Up Diagnosis and Embracing Telehealth in 2015

January 29, 2015 8:30 am | by Dan Piekarz, Vice President of Business Development, Life Sciences, DataArt. | Blogs | Comments

Technology implemented well is greatly increasing our ability to understand the human body and how to care for it. In 2015, next generation genetic sequencing techniques will be revolutionizing diagnosis of infectious disease, but the FDA's...

A CDRH Priority: Clinical Trials in the U.S.

January 28, 2015 3:47 pm | by Owen Faris, Ph.D., and Jeffrey Shuren, M.D., J.D. | Blogs | Comments

At the Center for Devices and Radiological Health (CDRH), clinical trials are the foundation for our decisions to approve the most important medical devices—products that have the potential to save or sustain life, but that also present the greatest...

Improving Reliability of Automated External Defibrillators

January 28, 2015 11:05 am | by U.S. Food and Drug Administration | News | Comments

The U.S. Food and Drug Administration announced today that it will strengthen its review of automated external defibrillators (AEDs) to help improve the quality and reliability of these devices. The FDA issued a final order that will require...

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