Earlier this month the Centers for Medicare and Medicaid Services released four new proposals to amend portions of the Sunshine Act.

There are four proposed changes:

a) Eliminate the continuing medical education (CME) exclusion from reporting requirements.
b) Require companies to specify the marketed name of a drug, device, biologic or medical supply associated with a certain payment whereas previously companies could simply identify the therapeutic area or product category.
c) Require companies to report  to report stock, stock options or any other ownership interest as distinct categories.
d) Eliminate the definition of "covered device."

As many experts responded, the ink is barely dry...

July 23rd, 2014
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Chronic disease is typically not assiciated with slim-legged, flat-bellied beauty.

And yet, that is exactly the conversation that Type 1 Diabetic and Miss Idaho contestant chose to have when she donned a black swimsuit and wore her tslim touchscreen insulin pump from Tandem Diabetes proudly on stage. 

But Sierra Sandison, the newly crowned Miss Idaho, didn't stop there. She posted her picture on Instagram with a short write-up and launched the hashtag #showmeyourpump thereby issuing  a clarion to call to diabetics. Here is what she wrote on Instagram along with posting the above photo: 

There it is. I would never have dreamt of posting a swimsuit picture on social media, but diabetics from all over the country have been asking to see me and my insulin pump on the #MissIdaho2014 stage. Honestly, it is...

July 21st, 2014
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Few surgeons know the price of implantable devices such as orthopedic implants, which are among the most expensive medical devices, often blamed for contributing to rising overall healthcare costs.

Separately, the federal government has been investigating the overuse of implantable defibrillators by surgeons for the past four years and that has lessened the number of procedures.

Still, neither a government investigation nor surprising study results showing the lack of pricing awareness of orthopedic surgeons is going to meaningfully bend the overall cost curve of healthcare. 

Reigning in costs has to...

July 18th, 2014
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It is puncture itself that causes risk.” That is a quote from H.C. Jacobaeus, the first person to perform a laparoscopic surgery on a human. Over a century after Jacobaeus said this we are still grappling with surgical complications from punctures. Trocar insertion errors, for example, account for the largest number of complications related to laparoscopic surgery. Nikolai Begg, a PhD student in mechanical engineering at MIT, hopes that his novel device – a “flexure-based puncture access mechanism” - will take the danger out of procedures that Begg likens to drilling through a piece of wood or inserting a straw into a Capri Sun drink to his TEDxBeaconStreet talk.

...
July 16th, 2014
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Germany has more to brag about than a World Cup championship (thanks to a late-game goal that put the nail in Argentina's coffin in the final). The country is also home to a thriving medical device industry showing impressive strength in all areas ranging from R&D and medtech startups to regulation and market growth. While the eurozone crisis and global recession crippled some countries and brought others to their knees, fiscally conservative Germany has weathered the storm and maintained a growing healthcare sector.
 
Here are some of the must-read stories on the trends and companies that are marking Germany's medical device industry.
 
 
What's Germany's Secret?
 
What...
July 14th, 2014
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St. Jude Medical's CardioMEMS acquisition brought to the Minnesota device a breakthrough heart monitoring device meant to serve as an early alert system for chronic heart failure patients. The FDA recently cleared it.

The CardioMEMS implantable sensor

In a clinical trial of 550 patients, the CardioMEMS system, the world...

July 14th, 2014
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The decision may further narrow the situations where patent holders may assert a claim of induced infringement in the medical device space. 

By Jeremy Lowe

In a unanimous opinion delivered June 2, 2014, the Supreme Court decided that Internet content delivery company Limelight Technologies Inc. was not liable for induced infringement of Akamai Technologies’ content delivery patents. Justice Samuel Alito, writing on behalf of the court, declared that the Federal Circuit “fundamentally misunderstands what it means to infringe a method patent” and held that there can be no induced infringement without direct infringement. Direct infringement, in the Supreme Court’s formulation...

July 10th, 2014
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Medical device companies will have to pay more attention during patent procurement to precisely defining their inventions.

By Jeremy Lowe

 

On June 2, 2014, the Supreme Court ruled unanimously in Nautilus Inc. v. Biosig Instruments Inc. that Biosig Instruments’ heart-rate monitor patent was invalid. Biosig had sued Nautilus Inc., its competitor, for allegedly infringing the patented monitor, and the District Court and the Court of Appeals for the Federal Circuit found that the patent was valid in favor of Biosig. Writing for the high court, Justice Ruth Bader Ginsburg disagreed with the lower courts’ rulings, saying the claimed “spaced relationship” design in Biosig’s patent may well be too...

July 9th, 2014
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America is a nation of choice.

Especially to someone who can remember only two government-controlled TV channels as a pre-teen in India in the 1980s, the choice that we as Americans have not only in terms of the idiot box, but everything else, is sometimes dizzying.

That choice has become even more widespread with advances in technology. We are forever making choices. We are constantly opting in and out. 

Except when it comes to healthcare. There, no matter what we would prefer, we are held fast to HIPAA. Imagine being only allowed to communicate using feather quills and ink while email and texting were readily available. 

Now Dr. Mark Blatt, Intel's Worldwide Medical Director, is expounding a radical though rational idea. Let patients decide whether they want to opt out of HIPAA guidelines. Blatt recently...

July 9th, 2014
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A Medtronic executive turned a few heads recently when he told MassDevice.com that when it comes to rivals, the medical technology company sees Google as its biggest challenger in the coming years.

That's right. Not Johnson & Johnson. Not Boston Scientific. And no, not Apple either, but the search giant Google.

While surprising, the statement is not completely coming out of left field. Experts have been talking about how Silicon Valley is poised to disrupt healthcare and medtech. There are plenty of examples of nontraditional firms innovating in healthcare these days.

Google itself is developing a...

July 8th, 2014
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