(Updated below)
Representative Erik Paulsen (R-MN) is back at work trying to eliminate the 2.3% excise tax that medical device companies are set to pay as part of last year’s healthcare reform act.

Paulsen introduced the Protect Medical Innovation Act on Tuesday, a bill that would do just that. Last year, Paulsen introduced the Defend Medical Innovation Act, which would have accomplished the same thing had it been able to pass before the end of the congressional session. This year’s Protect Medical Innovation Act has 41 cosponsors; Orrin Hatch (R-UT) introduced will introduce companion legislation in the Senate.

Paulsen’s current bill may be flying a bit under the radar so far, slightly overshadowed by both President Obama’s State of the Union address and Republicans’ broader attempts to repeal the so-called “jobs-killing” healthcare reform act, but I’m guessing it’s no less relevant to medical device...

January 26th, 2011
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You may not have heard of anaplastic large cell lymphoma (ALCL), but for those in the breast implant business, you should get to know the term. FDA is investigating a possible link between breast implants and this rare cancer.
 
FDA is aware of about 60 cases worldwide of ALCL in women with breast implants (including saline and silicone). This may not sound like much considering that 5–10 million women have implants, but clearly it's something that the public—specifically women getting implants—may want to know. And of course the makers of these implants—namely Allergan Inc. and Mentor Worldwide LLC (a J&J company)—have a stake in the situation as well.
 
"Data reviewed by the FDA suggest that patients with breast implants may have a very small but significant risk of ALCL in the scar capsule adjacent to the implant," the agency said in a statement.
 
The topic has been explored before in...

January 26th, 2011
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Less than a week after igniting a minor firestorm of debate regarding its overhaul (or lack thereof) of 510(k) regulations, FDA is tackling another longtime lightning rod (pun guiltily intended) of controversy: electroshock therapy.  

The agency is considering whether it should downgrade devices used in electroshock therapy (also known as electroconvulsive therapy, or ECT) from Class III (high risk) to a lower class, like Class II (medium risk), according to a story in The New York Times. An advisory panel will review the devices this week, and the agency could make a decision about them later this year.

When the three classes of medical devices were established in 1976, ECT devices (along with about 20 other devices) were...

January 25th, 2011
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Left ventricular devices assist devices (LVADs) offer hope to patients with heart failure and the technology is progressing quickly. But unnecessary requirements by FDA could suppress device innovation and access, says a report from the American Enterprise Institute for Public Policy Research.

The report, "Are Medical Devices Turning the Corner against Heart Failure?" examines 20 years of data on heart failure treatments and concludes that the latest technology in the form of LVADs hold significant promise and could "mark a transition to a new stage for devices in medical practice.

The report also discusses the complex issues of reimbursement and the high price-tag associated with such devices (more than $100,000, including implantation and post-op care)....

January 25th, 2011
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Its less than a week before we embark on a new event here at MD+DI. This is the first virtual trade show I've been part of and I'm very excited.

During the Implantable Devices Virtual Conference I'll be hosting a chat session on wireless implant technology.

There is also an incredible line up of experts discussing implant design topics including orthopedic and cardio applications directly with Q&A opportunities, live chat sessions, and panel discussions.

Topics include implant surfaces, optimizing battery life, design innovations in orthopedics, and biomaterials in cardio applications.

In case you are a little apprehensive, this is attending several webinars, plus visiting suppliers (or looking for new ones) all at your desk. The online set up looks...

January 21st, 2011
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InHealth is conducting a survey to collect input from individuals involved in the design and development of medical products regulated through FDA’s premarket notification (510(k)) pathway to market clearance.

Individuals with recent experience of the 510(k) process are being sought to participate in the industrywide survey by visiting the study’s website at www.510k.net.

Let MDDI know what you think of the survey.

—Heather Thompson

January 21st, 2011
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The latest from Josh Simon: 

Here is my beef:  I see it commonly.  A hydrophilic coatings company will “whip up” a coating and put it on the market.  Putting it on the market is not a problem.  “Whipping it up” is, especially when the company goes on to make all kinds of ridiculous marketing claims about it, many of them patently false or unproven.  I wish the Federal Trade Commission (FTC) would take a look at some of these claims, honestly.  As a generic example, “XXXX is the most lubricious coating available.” or “XXX enhances the design features of any device.”  These sorts of claims often come from companies that never show testing data beyond 10 cycles.  Anyone can do that.  Essentially, these claims are made without any meaningful data to back them up.

Read the entire article on...

January 20th, 2011
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On January 19, FDA released its 25 action items for 510(k) (pdf) overhaul. These items emphasized the less controversial portions of the proposed changes.
Among the good for industry: language about streamlining the classification process for low-risk products (de novo), greater training for FDA examiners, and greater transparency into the FDA process.
The Institute of Medicine is charged with its own investigation of the 510(k) process and will make recommendations on the the more-controversial aspects of the proposals released by the agency in 2010. These items include the creation of a new Class IIb of devices and recommendations that FDA develop processes for revoking a 510(k) approval and for requiring studies of a device after it is launched on the market.
Other actions identified by FDA include the following:

  • Clarifying when clinical data should be submitted in a premarket submission, guidance that will increase the...
January 20th, 2011
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The global women's health market, valued at $20 billion in 2009, is dominated by the United States, says a new report on women's health from PharmaLive.

According to the report, the women's healthcare market segment has a strong demand for novel therapeutics and improved diagnostics. Therapeutic categories gaining increased attention within this market include breast cancer, oral contraceptives, hormone therapy for menopause, heart disease, rheumatoid arthritis, and gynecologic infections including STD's and osteoporosis.
 

The report predicts that diagnostic imaging applications showing increasing market potential include bone densitometry, breast biopsy and imaging, OB/GYN ultrasound imaging, and fetal & neonatal monitoring. These disciplines represent almost half of the women's health market segment in terms of cost.

More information is available in Women’s Health Review and...

January 20th, 2011
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Have you seen this ad or one like it? Lawyers—already an opportunistic bunch by most accounts—have been trying to capitalize on defective drugs and faulty medical devices. The Orlando Sentinel takes a look at the litigation process on the patient side, asking one basic question: sue on your own or with others? There is strength in numbers,...

January 19th, 2011
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