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Regulating Hip Replacement Devices to Prevent Unnecessary Surgery

March 11, 2015 9:08 am | by University of Warwick | News | Comments

A new study from the University of Warwick is calling for more UK compulsory regulation of devices used in hip replacements to reduce the need for further traumatic and expensive surgery. In a paper published today in the British Medical...

Automating SOP Management Helps Medical Device Manufacturers Avoid Risk

March 10, 2015 11:23 am | by Mika Javanainen, Senior Director, Product Management, M-Files Corporation | Articles | Comments

Medical device manufacturers must comply with increasingly strict compliance requirements in order to sell products in the United States. The Current Good Manufacturing Practices (cGMP) and Quality System regulations (21 CFR Parts 211 and 820)...

Medical Device Designers' Guide to FDA’s Substantial Equivalence

March 9, 2015 11:15 am | by Quynh Hoang, Lynette Zentgraft, Senior Regulatory Experts; Elaine Tseng, Partner, King & Spalding | Articles | Comments

A Premarket Notification or “510(k)” submission is the most common pathway by which medical devices receive authorization to enter the U.S. market, with over 3,500 510(k)s submitted to the U.S. Food and Drug Administration (FDA) yearly. FDA...

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Unregulated Internet Marketing of Cancer-Related Gene Tests

March 6, 2015 9:40 am | by Dana-Farber Cancer Institute | News | Comments

Websites that market personalized cancer care services often overemphasize their purported benefits and downplay their limitations, and many sites offer genetic tests whose value for guiding cancer treatment has not been shown to be clinically...

6 Tips to Understand the Collaborative Innovation Cycle

March 6, 2015 8:46 am | by Kathryn Stecco, M.D., Co-Founder and Chief Medical Officer, Panthera MedTech | Blogs | Comments

The medical device landscape is littered with failed products produced by companies whose management forgot - or ignored or didn't know - the cardinal rule of assessing potential value: Validate the market based on physician input before...

Testing the Claims of Digital Healthcare Devices

March 5, 2015 1:26 pm | by GE Reports | News | Comments

A century ago, Sigmund Freud developed the radical idea that there is a lot more going on inside our heads that we know. Today, many doctors (and patients) still stick by his groundbreaking theory. But it comes with a problem. As neuroscientist...

FDA Launches Drug Shortages Mobile App

March 5, 2015 9:07 am | by U.S. Food and Drug Administration | News | Comments

Today, the U.S. Food and Drug Administration launched the agency’s first mobile application (app) specifically designed to speed public access to valuable information about drug shortages. The app identifies current drug shortages, resolved...

A Look Ahead: 3D Printing for Final Device Manufacture

March 5, 2015 8:30 am | by Clive Nicholls, Product Design & Development Manager, Owen Mumford | Articles | Comments

The applications of 3D printing in the medical industry will continue to grow throughout 2015 and beyond. Recent research by SmarTrech shows that by 2020 the number of 3D printers being shipped annually for medical use will have almost...

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5 Tips to Maximize Intellectual Property Portfolio Value

March 4, 2015 12:04 pm | by Frank Becking, Co-Founder, IP Counsel, Chief Technology Officer, Panthera MedTech | Blogs | Comments

A strong Intellectual Property (IP) position can be one of a start-up company's most valuable assets. A weak (or poorly defined) IP position can also be one its greatest liabilities. All this is particularly true for developers in the medical...

First FDA-Approved Rapid Ebola Test for Emergency Use

March 4, 2015 10:48 am | by University of Texas Medical Branch at Galveston | News | Comments

University of Texas Medical Branch researchers who helped assess the effectiveness of a new rapid test kit to diagnose Ebola learned this week it has received emergency use authorization from the Food and Drug Administration. "The kit was...

6 Common Failures in Mobile Health App Development

March 3, 2015 10:43 am | by Delmar Howard, mHealth Program Manager, Intertek | Blogs | Comments

Widespread adoption of mobile devices and apps in healthcare is growing. Yet, as the industry rushes to market with new mobile health offerings, they often are met with confusion and uncertainty in such a new arena. Recent draft guidance...

Low-Risk Medical Apps Will Not Need FDA Regulation

March 2, 2015 8:52 am | by Megan Crouse, Real Time Digital Reporter, @abmdigi | News | Comments

Makers of health apps can breathe easier now that the FDA has outlined new standards for what does and does not constitute a digital medical device. The FDA will not enforce regulations for wearables that receive information from medical...

Washington D.C. Healthcare Summit Tackles Barriers Hindering Quality Care

March 2, 2015 8:46 am | by Healthcare Leadership Council | News | Comments

Leaders from health insurance companies, hospital systems and device- and drug-makers may debate loud and often about pricing models, payment methods and patient management, but they agree on one point: The American health care system raises...

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FDA, Experts Eye National Postmarket Surveillance

March 1, 2015 12:00 pm | by AAMI | News | Comments

Citing a need to provide better evidence for the risks and benefits of medical devices, a new report, commissioned by the U.S. Food and Drug Administration (FDA), outlines a seven-year plan to develop a system for monitoring device performance...

Rare Diseases at FDA: A Successful Year for Orphan Products

February 28, 2015 8:30 am | by Gayatri R. Rao, M.D., J.D. | Blogs | Comments

2014 was a strong year for rare disease product development at FDA. It was also a year of significant firsts. In recognition of Rare Disease Day, February 28th, we want to reflect on the progress we have made thus far as we renew our commitment...

FDA Approves Allergan’s Round Gel-Filled Breast Implants

February 27, 2015 9:14 am | by The Associated Press | News | Comments

Allergan, Inc. today announced that the company has received approval from the U.S. Food and Drug Administration (FDA) to market NATRELLE INSPIRA round gel-filled smooth breast implants. The NATRELLE INSPIRA line is different from other...

Johnson and Johnson Hip Suit Limps On

February 26, 2015 3:47 pm | by Megan Crouse, Real Time Digital Reporter, @abmdigi | News | Comments

After paying $2.5 billion in 2013 to settle lawsuits resulting from faulty hip implants, medical giant Johnson & Johnson will pay up to $420 million more to resolve lawsuits that were excluded from the 2013 settlement, according to...

Do You Have the Right to Be Disconnected?

February 26, 2015 9:24 am | by Megan Crouse, Real Time Digital Reporter, @abmdigi | Articles | Comments

We are all connected people, according to panelists brought together for Engineering Live: The Connected Person on Feb. 25, but the way we balance connectivity and privacy is still being determined by our technology and our society. Engineering...

Bacterial Infections Associated with Duodenoscopes: FDA’s Actions to Better Understand the Problem and What Can be Done to Mitigate It

February 25, 2015 2:16 pm | by William Maisel, M.D., M.P.H. | Blogs | Comments

Duodenoscopes are flexible, lighted tubes that are threaded through the mouth, throat, and stomach into the top of the small intestine (duodenum). Duodenoscopes are used in more than 500,000 procedures, called endoscopic retrograde cholangiopancreatography...

Moving Toward a National Medical Device Postmarket Surveillance System

February 25, 2015 8:30 am | by Jeffrey Shuren, M.D., J.D. and Thomas P. Gross, M.D., MPH | Blogs | Comments

Despite rigorous premarket evaluation, what really counts is how well a medical device works when it’s used day-to-day by patients, caregivers and clinicians. Beyond clinical trials, real-life patient experience may reveal unanticipated...

Smartphone Apps Aren't Doctors

February 24, 2015 3:19 pm | by Sam Brusco, Associate Editor, @SamISureAm | Blogs | Comments

Something a smartphone can never accomplish is acquiring a medical degree. (Yet, as those who live in the constant fear of a robot uprising will say.) The so-called “melanoma diagnostic apps” MelApp and Mole Detective have learned this...

HeartWare International Recalls Older Clinical Trial Controllers

February 24, 2015 11:54 am | by PR Newswire | News | Comments

HeartWare International, Inc. is issuing a voluntary Urgent Medical Device Recall in the United States related to older HeartWare Ventricular Assist System Controllers, which were distributed in the U.S. during the clinical...

FDA Cites ‘Complex Design’ of Scope in Safety Advisory

February 24, 2015 8:44 am | by AAMI | News | Comments

The U.S. Food and Drug Administration (FDA) is urging healthcare facilities to be vigilant in cleaning a certain type of endoscope, known as a duodenoscope, that has been linked to the spread of a deadly type of bacteria in facilities nationwide...

Looking Ahead In the Wake of CES Device Reclassification

February 24, 2015 8:30 am | by Mike Fegley, Electromedical Products International | Blogs | Comments

In June, the Food and Drug Administration (FDA) announced its intention to reclassify cranial electrotherapy stimulation (CES) devices from a class III to a class II designation, ending a battle that the CES industry has fought with the...

Embedded Technology: The Vital Organ of Wireless and Connected Health

February 24, 2015 8:30 am | by Chris Ault, Senior Product Manager, QNX Software Systems | Blogs | Comments

The advent of smartphones and other mobile devices has given us a daily mechanism to share and access information on an unprecedented level. Consider how a smartphone can transform the simple ritual of getting a caffeine fix. An integrated...

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