By Jim Dickinson

If your company is among the recipients of more than 100 letters from CDRH rescinding a marketing clearance under Sec. 510(k) of the Food Drug and Cosmetic Act, you’re now arguably free to resume marketing the affected device because FDA’s letters are illegal. That’s the bottom line of a September 26 decision by the Court of Appeals for the D.C. Circuit.

In a 2-1 decision with a whiff of politics about it, the George W. Bush–appointed majority overwhelmed its Obama-appointed colleague to rule in Ivy Sports Medicine v. Burwell that FDA cannot short-circuit the statutory medical device reclassification process by rescinding a 510(k) decision in what FDA...

September 30th, 2014
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If the fanfare over the iPhone 6 has proven anything it's that Apple's customers are just as loyal and rabid as ever. Meanwhile, the last time people waited in line for hours for a Google product was...well, it hasn't ever happened.

However, in a piece for Forbes, writer Dan Munro argues that Apple's popularity won't necessarily give the company a leg up in the healthcare space—especially given how deeply Android phones have penetrated the market. While Apple may be a top selling brand, it's the only one with iOS phones. Phones that run on Google's Android OS outnumber iPhones 2-to-1 according to estimates.
 
Munro argues for three key reasons Google will win out over Apple in the healthcare space:
 
1.) Google is winning with software...
September 29th, 2014
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Manufacturers of Class III medical devices are now required to submit unique device identification data to FDA’s Global Unique Device Identification Database. Here’s how to ensure the process goes smoothly.

By Denise Odenkirk

Starting September 24, 2014, manufacturers of Class III medical devices have been required to submit unique device identification (UDI) data for their products to FDA’s Global Unique Device Identification Database (GUDID). In the coming years, this requirement will extend to manufacturers of Class II and Class I devices as well.

To comply, many manufacturers are choosing to leverage UDI to achieve a more consolidated view of product data within their organizations. Having a holistic technology solution that generates the required Health Level 7...

September 25th, 2014
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 By Melissa Masters

Cybersecurity is a growing concern in all aspects of our lives. From our home computers, servers that store our credit card information and identities, and now our medical information and medical devices that we rely on to keep us healthy (and even alive in some cases) are all at risk. But, with new FDA guidance and growing media awareness, the bar is being raised regarding the expectations for a secure device. At the same time, the opportunities for attacks by cyber criminals are increasing. Securing devices, systems, and infrastructure is a critical issue for all of our safety and the challenges here are great.
 

...

September 24th, 2014
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If you're heading to Minneapolis October 29 and 30 for the show, here are four happenings you'll want to catch.

Minneapolis has long been the center of the medical device universe, serving as a home to industry giants and startups alike. And on October 29 and 30, 2014, thousands of other industry professionals will converge on this important medical device industry hub for MD&M Minneapolis, the Midwest’s largest medical design and manufacturing conference and exposition. If you’re heading to Minneapolis for the show, here are five happenings you won’t want to miss.

Conference Sessions

Stay on top of industry trends and developments by attending some of the educational sessions available at the...

September 23rd, 2014
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FDA has announced its intention to issue draft guidances on the regulation of laboratory-developed tests—a controversial decision that could increase the burden of compliance and stifle innovation.

By Allyson B. Mullen

Allyson Mullen

For decades, FDA has asserted that it has the authority to regulate laboratory-developed tests (LDTs). But on July 31, 2014, FDA took its biggest steps yet toward actively regulating such tests: FDA notified Congress of its intent to issue two draft guidance documents regarding oversight of LDTs, entitled “Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs)” and “...

September 19th, 2014
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Historically, the United States has been at the forefront of innovation in the life sciences. And yet there appears to be evidence that the dominance the country has held for decades may be fading. Upstarts in emerging regions like Asia are catching up making the U.S. somewhat of an old guard.

Data and charts from the Life Sciences Cluster Report published in June by Jones Lang LaSalle, a commercial real estate firm, capture this shift. The data was shared at a recent event organized by LifeScience Alley, a Minnesota industry association.  The analysis is based on the number of Patent Cooperation Treaty applications...

September 18th, 2014
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By Wendy Mach and Jennifer Gygi

           
The dark areas indicate where the seal is starting to clarify.

Before package testing can begin, there are several items that need to be considered, including—but not limited to—cost, sample size, test method, and acceptance criteria. Arriving at the perfect combination of variables in a packaging test validation procedure is just the beginning.

But what if your packaging fails to perform as expected?  The answer is simple: investigate. A test failure does not automatically mean that the packaging is inadequate. It does, however, demand evaluation and adjustments. A...

September 12th, 2014
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We routinely talk about advances in medical technology, recording excitement from physicians who believe that new technologies that can prove their clinical effectiveness will bring better outcomes for patients.

Startups developing innovative technologies are also aiming to change the status quo of conventional disease treatment. But this infographic from medexsupply.com succinctly captures how far medical technology has altered over time that has resulted in huge changes in the way everything from the common cold to mental conditions are treated.  

...

September 12th, 2014
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New technologies, regulations, and corporate megamergers have made summer 2014 a busy one for medtech. The programming at MD&M Chicago is geared toward keeping you on top of the latest industry trends. 

Keynote Speakers

In the wake of their recently announced merger, MD&M Chicago will be featuring keynote presentations from representatives from both Medtronic and Covidien. On Thursday, October 16, Dr. Todd Zielinski, senior principal scientist at Medtronic, will share case studies on deep...

September 10th, 2014
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