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Improving Research on Health Information Technology

February 11, 2015 10:11 am | by Rand Corporation | News | Comments

Studies about the value of health information technology can be improved by broadening the reviews to include both costs and benefits, and lengthening study periods to capture long-term implications, according to a new RAND Corporation analysis...

4 Questions to Ask when Validating Quality Computer Systems

February 11, 2015 8:30 am | by Penny Goss, Penny Goss Technical Solutions | Articles | Comments

The FDA (Food and Drug Administration) and IEC (International Electrotechnical Commission) requirements for validation of your manufacturing and quality system software can conjure up a lot of questions. Understanding the actual guidelines...

Make Sure the Optimum Solution is Integrated into the System

February 11, 2015 8:30 am | by Matt Kelly, Key Account Manager, Medical, Watlow | Blogs | Comments

Home healthcare can provide significant benefits to patients in terms of quality of life and cost of care. However, the use of medical devices in the home also presents unique challenges and potential safety risks. Home medical care is outside...

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Analyzing Cures Before They Reach Veterans

February 10, 2015 2:09 pm | by Megan Crouse, Real Time Digital Reporter, @abmdigi | News | Comments

A new testing center for medical products used to help veterans has been opened at the Veterans Affairs medical center in Pittsburgh, the VA announced on Jan. 30. The Center for Medical Product End-user Testing is responsible for evaluating...

8 New EMC Requirements for Medical Devices

February 10, 2015 11:52 am | by Bruce Fagley, TÜV Rheinland, EMC Technical Manager | Blogs | Comments

The fourth edition of the IEC 60601-1-2:2014 standard is out, introducing significant technical changes in electromagnetic compatibility (EMC) requirements and tests for medical equipment and systems. The revision mandates compliance of new...

FDA Considering How to Tailor its Oversight for Next Generation Sequencing

February 8, 2015 11:00 am | by Margaret A. Hamburg, M.D., Commissioner, Food and Drug Administration | Blogs | Comments

FDA is weighing the appropriate regulatory approach to advances in technology that allow physicians to obtain information on large segments of a patient’s genetic makeup very quickly. This technology is known as next generation sequencing...

7 Lifesaving Facts About Artificial Hearts

February 7, 2015 8:30 am | by SynCardia Systems, Inc. | News | Comments

For patients suffering from end-stage biventricular (both sides) heart failure, a donor heart transplant is the standard of care. However, not all patients waiting for a donor heart will have one available to them when they need it to save their...

Save Money by Avoiding Multiple Failures During Evaluation

February 7, 2015 8:30 am | by Ajay Sankhla, Senior Engineering Consultant, Intertek | Blogs | Comments

The adoption of new and expanded payment and delivery models is spurring demand for home healthcare growth. But navigating the required patient and user safety standards that these technologies require is different than traditional clinical...

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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...  

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...

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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...   

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

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...

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