The Robots Have Arrived

After years of Intuitive Surgical's market dominance, 2016 was the year that new players of all sizes set their sights on entering the surgical robotics market.

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December 20th, 2016
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A Q&A with the CEO of Verb Surgical

Scott Huennekens, who heads Verb Surgical, told MD+DI about the company's plans to change the approach to robotic surgery.

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December 20th, 2016
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What Might Trump's Win Mean for Medtech?

The day after the presidential election, MD+DI took an early look at what might be in store for the Affordable Care Act, the medical device tax, FDA, and CMS under the incoming Trump administration.

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December 20th, 2016
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Take a look back at the biggest news stories of 2016 in medtech.

In retrospect, 2016 stands out as a memorable year because of the controversies, company transformations, and political changes it brought.

We've curated a list of the biggest news stories of the year in medtech.  That list includes stories on major medtech companies like Stryker, Johnson & Johnson, and Abbott, as well as announcements from new entrants and analysis of the impact political change may have on the industry.

These were the most popular news stories on MD+DI this year.

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December 20th, 2016
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Abbott + Alere + St. Jude (+Thoratec) = One Messy Deal?

Abbott announced big deals in 2016, including an acquisition of Alere (which Abbott is now trying to terminate) and the $25 billion purchase of St. Jude Medical. Such a major buy will requre a major integration process too. 

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December 20th, 2016
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Stryker to Build New 3-D Printing Manufacturing Facility in 2016

Stryker announced in January that it would build a new 3-D printing manufacturing facility in order to innovate new products. A couple months later, details emerged that the facility will be located in Ireland.

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December 20th, 2016
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4 Products Coming Down the Pike at St. Jude Medical

St. Jude Medical had a number of products expected to receive FDA approval or clearance this year. Readers were eager to learn more about some of these devices.   

Read more here . . . 

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December 20th, 2016
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Finally, Details on Medtronic's Robotics Platform

The medtech giant talks about what procedures its robotics platform will target, when to expect the launch, and the surprising region the company has chosen for the debut.

Read more here . . . 

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December 20th, 2016
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Details on Boston Scientific's Leadless Pacer Emerge

In February, MD+DI reported that Boston Scientific was developing a new leadless pacemaker that could be used in coordination with the subcutaneous S-ICD. A senior Boston Scientific executive later gave MD+DI exclusive details on the device.

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December 20th, 2016
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The main theme running through FDA's guidance on ISO 10993-1 is that every medical device should be assessed for its specific risk to the end user. 

Audrey Turley and Thor Rollins

In June 1906, President Theodore Roosevelt signed into law the Food and Drug Act, which addressed "adulterated" products. Adulterated includes the addition of fillers of reduced "quality or strength;" coloring to conceal "damage or inferiority;" formulation with additives "injurious to health;" or the use of "filthy, decomposed, or putrid" substances in a product. It took until 1995 for FDA to release an official guidance specific to medical device regulation.

This document, known as the “blue book,” was the basis of biocompatibility regulation for decades. FDA published a draft...

December 20th, 2016
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