The agency should have gone for a notice of proposed rulemaking instead of a draft guidance when it comes to its oversight of laboratory-developed tests.

By Jim Dickinson

In its pending Framework for Regulatory Oversight for Laboratory Developed Tests (LDTs), FDA is making an audacious and potentially futile power grab.

Futile because however justified by public health concerns, the vehicle the agency has chosen is the legally vulnerable guidance document. Like anything FDA says publicly as an institution, the content of guidance documents is there to be weighed, interpreted, and tested in diverse forums (including courtrooms).

Moreover, the content is currently devoid of regulatory force. Every FDA guidance bears on its first page a boldly boxed statement saying it...

January 23rd, 2015
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[Image Credit: iStockphoto.com user Nerthuz]

 

January 22nd, 2015
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TAVR, Lotus heart valve, Boston Scientific Lotus
Boston Scientific's Lotus TAVR Valve System

 

Transcatheter aortic valve replacement (TAVR) therapy, while expensive, has come to be accepted as a viable and desirable alternative to invasive open-heart surgery to treat patients with diseased heart valves.

Two names dominate the market - Medtronic and Edwards Lifesciences. Various generations of both companies’ products - Edwards' Sapien and Medtronic's CoreValve - are available in the U.S. and physicians have become trained in the choices available.

That means that companies like Boston Scientific may be too late to the party.

"Boston Scientific will be...

January 21st, 2015
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Alex Gorsky sounded a positive note in J&J's 2014 year-end earnings call today. Is it blind optimism or a sign of good things ahead for medtech? 

Gorsky

Johnson & Johnson CEO Alex Gorsky knows how to start the year off on a positive note. Although the company's worldwide medical device sales dipped 4.7% in 2014, he seems to already be looking to the future with rose-colored glasses.

According to a Seeking Alpha transcript of the company's fourth-quarter 2014 earnings call today, Gorsky—who also...

January 20th, 2015
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Repealing the 2.3% medical device tax has taken on new urgency.

There are bipartisan bills from both the Senate and the House aimed at killing this tax that many in the industry find unpalatable. The tax has been collected for two years.

...
January 20th, 2015
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Dozens of patients claiming they were permanently injured by LASIK procedures have banded together on the Internet to exchange information and pressure FDA to take strong action against LASIK marketers.

By Jim Dickinson

What happens when an irresistible force meets an immovable object? Although logic says the two cannot exist at the same time, FDA may be about to find out, as it did in 1988, when persistent street demonstrators forced it to adopt emergency regulations slashing the review time for AIDS drugs.

This time, short of actual street demonstrations, the unreformed agency faces an equally persistent though numerically much smaller community of LASIK victims determined to force it to warn the public about an...

January 14th, 2015
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Medtech suppliers are the innovation engine that drives the overall medical device market worldwide.

To recognize that, UBM Canon invites MD&M West exhibitors - based in the U.S. and Canada - to participate in the Supplier Innovation Challenge, a contest that will acknowledge the most innovative products, services, and technologies developed in recent years by exhibitors.

Do you offer a breakthrough antimicrobial coating that could dramatically reduce instances of hospital-acquired infections, for example? Or have you pushed the boundaries of...

January 14th, 2015
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The medical device tax is being collected over the past two years, but with solid Republican control in Congress, talks of a repeal has heated up.

Some are predicting that it will be struck down as early as March although it's unclear whether President Obama will veto the repeal. 

Others, however, don't think the tax is going away. 

"I think it’s a lot of happy talk," said Brent Ahrens, seasoned life sciences VC with Canaan Partners, in an interview at the JPMorgan Healthcare Conference in San Francisco, Tuesday. "And at the end of the day, our companies have said, 'It is what it is. It’s a change in the ecosystem, it’s the cost of doing business, what...

January 13th, 2015
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Bioresorbable polymers are enabling the development of an increasing number of next-generation medical devices that benefit from the materials' ability to perform a specific function and then dissolve safely in the body. But the potential applications for bioresorbable and biodegradable polymers have been limited, to some extent, by the inherent properties of PLA and PGA, the most commonly used bioresorbable polymers.

Secant Medical is hoping to help push the boundaries of bioresorbable polymers, however, with the introduction of its Regenerez bioresorbable elastomer.

"[Regenerez] is very tough, elastic, elongates. This is a big differentiator," notes Brian Coffin, business development engineer at Secant Medical. "It's a bioresorbable that's elastomeric in nature instead of very stiff and tough like the PGAs and PLAs that have been in the market...

January 11th, 2015
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Talk of medical device tax repeal is back in circulation.

What was a bitter pill in 2013 and 2014 that the industry had largely swallowed is now on the front burner given that Congress is now firmly under Republican control. A bipartisan bill in support of the repeal has been introduced in the House and some predict the 2.3% medical device tax can be repealed by March.

The question is how much overall damage has the device tax done? And what is the true tax burden? Numbers like $20 billion and $30 billion in taxes collected over a decade are getting thrown around a fair bit in media coverage, so it's a question worth asking.

Industry proponents and critics of the tax have loudly proclaimed...

January 9th, 2015
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