Showing posts with label device. Show all posts
Showing posts with label device. Show all posts

Monday, July 1, 2013

Buyer's remorse over medical device tax

By Greg Sorensen, M.D., chief executive officer, Siemens Healthcare North America - 03/26/13 12:15 PM ET

There appear to be a few glimmers of constructive activity in Washington, D.C. Last week, the Senate moved the ball forward on an issue that is extremely important to innovation and jobs in the United States. By passing an amendment to repeal the medical device tax by an overwhelming 79-20 votes, the Senate has done the right thing for patients and the U.S. economy.
The United States Senate has now joined a bipartisan majority of the House of Representatives calling to repeal the 2.3 percent medical device excise tax that has already damaged the U.S. economy and claimed thousands of jobs.

The American medical technology industry is responsible for and supports nearly two million jobs, creating a growing trade surplus and developing the technology essential to advancing patient care in the United States and around the world. However, since the January 1 implementation of the medical device tax, manufacturers have already paid an estimated $388,000,000 to the Internal Revenue Service (IRS) so far this year, redirecting funds that could otherwise be directed towards investment in things like job creation and research and development.
The impact of these semi-monthly payments to the IRS is being felt far and wide. Every day, innovators in this dynamic industry work hard to improve the quality of life for patients by developing the next frontier of life-saving medical devices and imaging technologies. Meanwhile, the companies that manufacture these cutting-edge diagnostic and therapeutic tools are improving the health of the U.S. economy by supporting hundreds of thousands of jobs. From the physician reviewing a CT scan, to the technician performing a procedure, to the factory worker assembling a machine, the medical imaging and devices industry is an essential engine of economic growth.
The clock is ticking in Washington, and the tax continues to impact high-quality jobs and investments in tomorrow’s treatments and cures at companies large and small across the country. Repeal is critical in order to give this industry – and the thousands of Americans it employs – a much-deserved second chance.
Given the negative effects of the medical device tax, it’s not surprising that Republicans and Democrats in both the House and Senate are exploring alternatives. Fortunately, the 79-20 vote on Thursday is an important step towards reversing course and ensuring that the United States remains the global leader in medical technology innovation.

Sorensen is  chief executive officer of Siemens Healthcare North America and chairman of the MITA Board of Directors.

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Monday, June 24, 2013

Analyst: FDA OK unlikely for Abbott heart device

WASHINGTON -- A medical device industry analyst says Abbott Laboratories is unlikely to win approval anytime soon for its device used to repair heart valve problems, following a tepid endorsement by government experts.

A Food and Drug Administration panel of heart experts voted 5-3 on Wednesday that the benefits of Abbott's MitraClip system outweigh its risks. The panel voted unanimously that the device is safe and 4-5 on the question of whether the device is effective.

The company is developing the MitraClip to repair leaky heart valves.

Wells Fargo analyst Larry Biegelsen said in a note Thursday, "We believe FDA is unlikely to approve the device," until the results of another study are submitted. That study may not be completed until the summer of 2019, according to a government website.

The device is inserted through a catheter placed in the patient's leg. It clips together leaflets of the heart's mitral valve, which is between the left upper and lower chambers, to reduce significant mitral regurgitation. Mitral regurgitation can cause blood to flow backward into the heart's left atrium leading to an irregular heartbeat, heart failure, a stroke or heart attack.

Biegelsen said a delay in approval is unlikely to hurt Abbott's stock, since most Wall Street analysts had low expectations of the product's commercial potential going into the FDA review. Biegelsen holds an "Outperform" rating on the company stock.

Currently mitral regurgitation is treated with blood-thinning drugs for mild regurgitation or surgery for more severe cases. The MitraClip is intended for patients with significant regurgitation who may not be healthy enough to undergo surgery.

Following the meeting Wednesday, Abbott said in a statement, "We are pleased with the outcome of today's panel, and we look forward to continuing discussions with the agency regarding the panel's comments."

Shares of North Chicago, Ill.-based Abbott fell 33 cents to $33.48 in afternoon trading Thursday.


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Friday, June 21, 2013

UPDATE 1-Medical device maker Cytori loses approval fight

WASHINGTON, March 22 (Reuters) - A U.S. appeals court ruled on Friday that the Food and Drug Administration acted correctly when it denied fast-track approval of two stem cell-related medical devices made by Cytori Therapeutics Inc.

The FDA had reasonable evidence to find that the devices were not substantially equivalent to devices already on the market, according to the unanimous ruling from the U.S. Court of Appeals for the District of Columbia Circuit.

The FDA's decision meant that Cytori had to conduct extensive clinical research as part of premarket approval.

Tom Baker, Cytori's director of investor relations, said the court ruling does not change the status quo because the company has a clinical trial under way.

"That will continue to be our priority and primary path to market," Baker said in a phone interview on Friday.

The clinical trial started last year and the company plans to have initial data in the first half of 2014, he said.

Cytori is hoping to develop a treatment for heart failure in which regenerative stem cells from a patient's own fat tissue would be injected into heart muscle, all in one procedure.

The appeals court ruling relates to two medical devices designed to extract stem cells from fat tissue, the Celution 700 and the StemSource 900.

Cytori and the FDA disagreed over how similar the devices are to existing devices that extract stem cells from blood or bone marrow. Devices that are similar to already approved ones require less testing.

Judge Brett Kavanaugh wrote for a three-judge panel that the appeals court must be careful when questioning the scientific judgment of an agency such as the FDA.

"FDA concluded and explained that fat is not blood and that the difference matters. A court is ill-equipped to second-guess that kind of agency scientific judgment," Kavanaugh wrote.

An FDA spokeswoman declined to comment.


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Thursday, June 20, 2013

U.S. Senate may back symbolic repeal of medical device tax

WASHINGTON, March 21 (Reuters) - Opponents of a 2.3 percent tax on medical device companies will likely win passage this week in the U.S. Senate of a largely symbolic resolution calling for repeal of the tax, with some Democrats likely to join all Republicans.

The tax helps to fund President Barack Obama's 2010 healthcare law. It applies to a range of medical products - from bedpans to expensive heart devices - many manufactured in the home states of the senators backing the repeal.

The resolution calling for repeal will be symbolic because it will come in the form of a non-binding amendment to a non-binding budget measure drafted by Senate Democrats. The resolution would not actually repeal the tax.

Full repeal of the tax may be difficult to achieve, given its $30 billion price tag and the opposition of key Senate Democrats, including Majority Leader Harry Reid.

"The industry has a fighting chance of getting the tax moderated or eliminated as part of a much larger tax reform bill, where the device levy becomes a rounding error," said Paul Heldman, a policy analyst at Potomac Research Group. "But major tax reform in this Congress is a long shot."

Nine Senate Democrats are signed up to back the symbolic amendment. More than a dozen Senate Democrats wrote to Reid last year seeking to delay the tax.

Reid does not support repeal. Nor does Senate Finance Committee Chairman Max Baucus, who helped usher Obama's healthcare bill into law. The medical device tax is among several new industry levies in the healthcare overhaul law, which aims to provide health insurance for millions of Americans who lack it.

The law is being implemented. It was declared constitutional by the U.S. Supreme Court last year.

The medical device tax, which went into effect this year, is projected to raise about $30 billion over a decade. That government revenue would be lost if the tax were repealed.

Democratic Senators from Minnesota, Indiana and Pennsylvania, where some big medical technology companies are based, are among those who have been pushing for a repeal.

Industry officials and lawmakers against the tax say it will hurt innovation and job creation.

(Reporting by Kim Dixon; Editing by Kevin Drawbaugh and Jan Paschal)


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Medical device maker Cytori Therapeutics loses approval fight

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U.S. Senate may back symbolic repeal of medical device tax

WASHINGTON, March 21 (Reuters) - Opponents of a 2.3 percent tax on medical device companies will likely win passage this week in the U.S. Senate of a largely symbolic resolution calling for repeal of the tax, with some Democrats likely to join all Republicans.

The tax helps to fund President Barack Obama's 2010 healthcare law. It applies to a range of medical products - from bedpans to expensive heart devices - many manufactured in the home states of the senators backing the repeal.

The resolution calling for repeal will be symbolic because it will come in the form of a non-binding amendment to a non-binding budget measure drafted by Senate Democrats. The resolution would not actually repeal the tax.

Full repeal of the tax may be difficult to achieve, given its $30 billion price tag and the opposition of key Senate Democrats, including Majority Leader Harry Reid.

"The industry has a fighting chance of getting the tax moderated or eliminated as part of a much larger tax reform bill, where the device levy becomes a rounding error," said Paul Heldman, a policy analyst at Potomac Research Group. "But major tax reform in this Congress is a long shot."

Nine Senate Democrats are signed up to back the symbolic amendment. More than a dozen Senate Democrats wrote to Reid last year seeking to delay the tax.

Reid does not support repeal. Nor does Senate Finance Committee Chairman Max Baucus, who helped usher Obama's healthcare bill into law. The medical device tax is among several new industry levies in the healthcare overhaul law, which aims to provide health insurance for millions of Americans who lack it.

The law is being implemented. It was declared constitutional by the U.S. Supreme Court last year.

The medical device tax, which went into effect this year, is projected to raise about $30 billion over a decade. That government revenue would be lost if the tax were repealed.

Democratic Senators from Minnesota, Indiana and Pennsylvania, where some big medical technology companies are based, are among those who have been pushing for a repeal.

Industry officials and lawmakers against the tax say it will hurt innovation and job creation.

(Reporting by Kim Dixon; Editing by Kevin Drawbaugh and Jan Paschal)


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Wednesday, June 12, 2013

UPDATE 1-FDA staff does not recommend approval of Abbott's heart device

(Adds details, Abbott and analyst comments, stock movement)

March 18 (Reuters) - Staff reviewers for the U.S. Food and Drug Administration did not recommend the approval of Abbott Laboratories' implantable heart device MitraClip, citing a lack of "valid scientific evidence" of safety and effectiveness.

FDA reviewers said in briefing documents, posted on the regulator's website on Monday, that approval of the device would not be appropriate at the time as major questions of safety, efficacy and overall benefit-risk profile remained unanswered.

The device is being tested to treat mitral valve insufficiency - a disorder where a heart valve does not close properly when the heart pumps blood, causing blood to flow back into the heart - in patients considered high risk for open surgery.

The device is inserted into the blood stream using a catheter.

"The FDA staff is asking for more information. Abbott is conducting multiple trials on MitraClip, including the COAPT study, and the staff would want to look at that data," BMO Capital Markets analyst Joanne Wuensch said.

The COAPT trial is testing the device in high-risk inoperable and high-risk mitral valve patients. Abbott has also recently developed a European trial for the patient population.

Abbott had changed the proposed use for the device after the FDA expressed concerns that there was a lack of evidence to support its approval for a broader use in patients with significant mitral valve insufficiency, the reviewers said in the documents. ()

"FDA firmly believes that the currently enrolling COAPT and European trials are well-designed trials that will help to answer the many important questions posed by the very limited data analyses presented in this (approval application)," the reviewers said.

However, the reviewers recommended that MitraClip continue to remain available to high-risk patients as an investigational device so that Abbott can conduct its trials in an optimal manner.

"The MitraClip device represents a true advance for (high-risk) patients and we look forward to discussing the totality of the clinical evidence with the advisory committee members and hearing their recommendations on Wednesday," Abbott said in an emailed statement to Reuters.

An advisory panel of independent experts will discuss the data submitted by Abbott on the device and will vote on its safety, efficacy and risk profile.

BMO's Wuensch said her earnings estimate on Abbott did not include any expected revenue from MitraClip, adding that she believed the Street consensus also excluded any potential sales from the device.

Abbott shares were down 1.2 percent at $33.72 on the New York Stock Exchange on Monday.

(Reporting by Esha Dey in Bangalore; Editing by Maju Samuel and Roshni Menon)

((esha.dey@thomsonreuters.com; within U.S. +1 646 223 8780, outside U.S. +91 80 4135 5800; Reuters Messaging: esha.dey.thomsonreuters.com@reuters.net))

Keywords: ABBOTT FDA/MITRALVALVEDEVICE


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Saturday, April 6, 2013

UPDATE 3-Hospira gets FDA notice over medical device problems

* Rocky Mount plant back to capacity in 2013 -Hospira

* Q4 adjusted eps 55 cents vs Street view 54 cents

* Expects 2013 sales up 1 pct to 3 pct, adjusted diluted eps of $2.05-$2.20

Feb 13 (Reuters) - Hospira Inc, a hospital products maker that has grappled with regulatory issues at manufacturing plants for the past 18 months, said it had received a notice over the quality of its medical devices from the U.S. Food and Drug Administration.

The company reported the notice during a conference call on Wednesday after announcing a profit for the fourth quarter vs a year-earlier loss as sales of generic injectable drugs, IV solutions, drug pumps and other products increased more than 8 percent.

Hospira said the FDA completed an inspection of its medical device quality systems at its headquarters in Lake Forest, Illinois, last month and issued a list of 10 objectionable conditions. The list is known in the industry as a Form 483.

Some of the quality systems assessed as part of the Lake Forest inspection included supplier quality systems and medical device reporting and complaint systems, a Hospira spokeswoman said.

The company also said it sent notices to customers about some of its infusion pumps that had to either be recalled, fixed or adjusted.

Hospira has sent out 11 device notifications so far in 2013, including recall and device corrections, the spokeswoman said.

"While there may still be additional device field notifications going forward, we do not believe they will continue at the rate we have seen recently," she said in an email.

Shares in Hospira fell $2.05 to $32.90 in afternoon trading on the New York Stock Exchange.

Chief Executive F. Michael Ball said that FDA inspectors acknowledged some progress since the last inspection.

"The observations re-enforced our own assessment there is still a lot of work to be done within our device operations," Ball said on the conference call.

He said management had been doing a complete review of all of its medical devices even before the FDA notice. He said the new strategy would be aimed at modernizing and streamlining platforms.

Ball said there has been progress at some of its other manufacturing facilities that have had problems, including its Rocky Mount facility in North Carolina. Ball said a reinspection by the FDA would be extensive and lengthy but he expects it increase production this year.

He said Hospira's other plants emerged from shut downs on schedule.

Hospira's Clayton, North Carolina facility has resumed manufacturing propofol, an anesthesia that is administered intravenously and has been in short supply, and is building inventory in the fourth quarter of 2012 for an early 2013 relaunch.

He said the drug was being priced at a premium.

Hospira said it expects sales to rise 1 percent to 3 percent for 2013, and adjusted earnings per diluted share to be between $2.05 and $2.20.

Management said the relatively wide range is based on the expected rate of supply recovery and share gains, as well as improvements in quality and manufacturing performance.

In the fourth quarter, its net income was $5.3 million, or 3 cents per share, in the latest quarter, compared with a net loss of $214.0 million, or $1.30 per share, in the year-earlier period.

Adjusted earnings were 55 cents per share. On that basis, analysts on average were expecting earnings per share of 54 cents.

Net sales rose to $1.1 billion in the quarter from $1.0 billion a year before.


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Friday, April 5, 2013

UPDATE 2-Hospira receives FDA notice over medical device problems

* Rocky Mount plant back to capacity in 2013 - Hospira

* Q4 adjusted eps 55 cents vs Street view 54 cents

* Expects 2013 sales up 1 pct to 3 pct, adjusted diluted eps of $2.05-$2.20

Feb 13 (Reuters) - Hospira Inc, a hospital products maker that has grappled with regulatory issues at manufacturing plants for the past 18 months, said it had received a notice over the quality of its medical devices from the U.S. Food and Drug Administration.

The company reported the notice during a conference call on Wednesday after announcing a profit for the fourth quarter versus a year-earlier loss as sales of generic injectable drugs, IV solutions, drug pumps and other products increased more than 8 percent.

Hospira said the FDA completed an inspection of its medical device quality systems at its headquarters in Lake Forest, Illinois, last month and issued a list of 10 objectionable conditions. The list is known in the industry as a Form 483.

The company also said it sent notices to customers about some of its infusion pumps that had to either be recalled, fixed or adjusted. Hospira did not disclose the scope of the action nor the exact product models.

Shares in Hospira fell 67 cents to $34.28 in morning trading on the New York Stock Exchange.

Chief Executive F. Michael Ball said that FDA inspectors acknowledged some progress since the last inspection.

"The observations re-enforced our own assessment there is still a lot of work to be done within our device operations," Ball said on the conference call.

He said management had been doing a complete review of all of its medical devices even before the FDA notice. He said the new strategy would be aimed at modernizing and streamlining platforms.

Ball said there has been progress at some of its other manufacturing facilities that have had problems, including its Rocky Mount facility in North Carolina. Ball said a reinspection by the FDA would be extensive and lengthy but he expects it to resume production at full capacity this year.

He said Hospira's other plants emerged from shut downs on schedule.

Hospira's Clayton, North Carolina facility has resumed manufacturing propofol, an anesthesia that is administered intravenously and has been in short supply, and is building inventory in the fourth quarter of 2012 for an early 2013 relaunch.

He said the drug was being priced at a premium.

Hospira said it expects sales to rise 1 percent to 3 percent for 2013, and adjusted earnings per diluted share to be between $2.05 and $2.20.

Management said the relatively wide range is based on the expected rate of supply recovery and share gains, as well as improvements in quality and manufacturing performance.

In the fourth quarter, its net income was $5.3 million, or 3 cents per share, in the latest quarter, compared with a net loss of $214.0 million, or $1.30 per share, in the year-earlier period.

Adjusted earnings were 55 cents per share. On that basis, analysts on average were expecting earnings per share of 54 cents.

Net sales rose to $1.1 billion in the quarter from $1.0 billion a year before.


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Tuesday, March 26, 2013

GOP, Dems Call For Repeal Of $30 Billion Medical Device Tax

A bipartisan group of 180 House members — consisting of about 40 percent of the House — has reintroduced a bill to end the 2.3 percent tax on medical devices that was imposed under President Obama's healthcare law.

That tax took effect at the start of 2013, and is expected to raise a few billion dollars a year in tax receipts for the government, and $30 billion over 10 years. But opponents of the tax say it will hinder innovation and job creation in the medical device industry.

"Placing a new tax on the backs of U.S. medical innovators and entrepreneurs who employ more than 400,000 Americans is not a prescription for economic growth or job creation," said Rep. Erik Paulsen (R-Minn.), who sponsored the bill. "In fact, companies have already laid off thousands of employees as a result of this onerous new tax, and more jobs will be lost now that this tax is in effect.

"It's not only costing our country jobs and deterring innovation, but more importantly, it will reduce patient access to cutting edge medical products and treatments that save lives."

Paulsen introduced a similar bill in the last Congress. The latest version would repeal the tax without offsetting spending cuts.

Last year, the House Ways & Means Committee amended his bill to provide for an offset, something that could happen again in the new Congress. Ways & Means attached language that would pay for ending the tax by requiring the government to recapture all overpayments of health insurance subsidies provided in the healthcare law. Under current law, only some of these overpayments must be returned to the government.

Overpayments of the subsidies are anticipated because the subsidies are based on prior years' income, and if it is discovered later that a family's income increases, some repayment would be required.

This offset led to a veto threat from President Obama, who argued that requiring all overpayments to be returned would be a tax on middle-class families. Republicans rejected the argument that recapturing subsidy overpayments is a tax, and said Democrats have also proposed this kind of offset before.

The House approved the amended bill last summer, in a 270-146 vote in which 37 Democrats supported it. But Obama's veto threat froze the bill in the Senate, which never considered it.

It remains to be seen whether the bill can grow more legs in this Congress now that the tax has taken effect. The effort to repeal the tax has bipartisan support in both chambers — in addition to the bipartisan House bill, H.R. 523, Sens. Orrin Hatch (R-Utah) and Amy Klobuchar (D-Minn.) will introduce a companion in the Senate.

"Repealing the medical device tax eliminates barriers to medical innovation, ensuring patients have access to life saving technologies and reduces the burden on tight R&D budgets, spurring job growth in the industry," said Rep. Ron Kind (Wis.), the leading Democrat on the House bill.

"Supporting and promoting American manufacturing, innovation, and research and development will increase our economic competitiveness and ensure our economy is built to last."

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Wednesday, February 20, 2013

St. Jude Q4 profit, medical device sales decline

ST. PAUL, Minn. -- Troubled medical device maker St. Jude Medical Inc. posted a 4 percent drop in fourth-quarter profit as higher taxes and a drop in sales for most of its products offset tight spending. The company still managed to top Wall Street profit expectations.

The maker of pacemakers, heart-shocking defibrillators and other medical devices has been plagued over the past few years by recalls of wires for several heart devices, and analysts worry another recall could be coming.

The company, based in St. Paul, Minn., said Wednesday that net income was $120 million, or 39 cents per share for the three month-period that ended on Dec. 29, down from $125 million, also 39 cents per share, a year earlier.

Excluding one-time charges totaling 53 cents per share, net income would have been $285 million, or 92 cents per share. The charges include ongoing restructuring charges, litigation costs, an income tax loss related to the settlement of an audit and write-offs for discontinued products.

Analysts surveyed by FactSet were expecting earnings per share of 89 cents, excluding charges.

Revenue totaled $1.37 billion, matching analysts' consensus forecast. Sales were down 2.5 percent, from $1.41 billion in 2011's fourth quarter.

Net income fell despite an 18 percent drop in spending on marketing and administrative expenses, to $451 million.

Sales fell 3 percent to $422 million for the company's best-selling products, heart defibrillators implanted in patients to correct dangerous irregular heartbeats and prevent heart attacks. Pacemaker sales dropped 11 percent, to $260 million.

In the one bright spot in the quarter, sales of products to diagnose and treat the dangerous irregular heartbeat atrial fibrillation increased 10 percent to $239 million.

The company said it expects earnings per share of 91 cents to 93 cents in the first quarter and $3.68 to $3.73 for all of 2013. Those numbers exclude expected restructuring charges.

Last week, analysts said they think the Food and Drug Administration may call for a recall of another heart wire product called Durata. Earlier this month the company said it had received a warning letter from the FDA after agency inspectors found inconsistencies in how the company manufactured and documented defibrillators. The FDA will not allow any new products to be made at the plant making the defibrillators until problems with manufacturing and quality control are fixed.

St. Jude shares lost 5 cents to $39.62 on Wednesday.


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Tuesday, February 5, 2013

New Desktop Plastic Recycling Device Could Make 3D Printing More Planet-Friendly

The Filabot. Photo by Whitney Trudo.

Over the last year or two 3D printing has enjoyed a boom of sorts, as the technology has decreased to a size and price that’s at least somewhat feasible for the average consumer or hobbyist. At the same time the cost of plastic filament — the raw material 3D printers heat and then deposit to fabricate objects — has kept use of the technology beyond the reach of most individuals.

But now there’s a new desktop system that not only has the potential to solve the cost-of-filament problem, but to also make 3D printing an ally in efforts to cut down on the average household’s plastic waste.

The Filabot was developed by an American college student, Tyler McNaney, who raised raised over three times his initial $10,000 goal with a Kickstarter campaign to get the project off the ground. Aficionados were paying $350 for the first-run version fo the device, which can transform most forms of household plastic waste into filament, as well as recycle failed 3D printing projects for another go-round. Treehugger has the details:

The Filabot can turn most types of plastic into filament, including HDPE, LDPE, PET, ABS, PLA and NYLON-101. That means the machine can turn most plastic waste you might have around your house into a building material. Things like milk jugs, soda or water bottles, trays, plastic wraps, water pipes, luggage, packaging, biodegradable plastics and even Legos can become something new.

This also means that 3D printed projects gone wrong can also be fed into the Filabot to be made again, giving more room for trial and error without the fear of creating lots of plastic waste.

This system lets us imagine a future where we’re not only 3D printing replacements or repair parts for our things instead of throwing them away, but using waste plastic to in the process.

Filabot had a successful Kickstarter campaign last year where supporters paid $350 to get a first run version of these machines and the team is slowly working out kinks to get them out to public, though no official price has been released yet.

On the other side of the equation — moving 3D printers themselves into the realm of everyday devices Americans keep in their homes — MakerBot recently unveiled a 3D printer for the consumer market. Then Cubify did them one better, releasing a consumer printer that’s smaller, more aesthetic, and, arguably most important, cheaper.

To give a few examples of the scale of plastic waste problem: Only 10 percent of the 300 million tons of plastic produced globally each year is recycled. In the United States specifically, 31 million tons were produced in 2010, and only eight percent was recycled. 51 billion plastic bottles are used globally every year, while only one in five are recycled. And plastic bags and cigarettes make up 80 percent of marine litter, and plastic bag litter has become such a huge problem that country’s around the world are taxing or outright banning them.

In some ways, the problem may actually be worse in the developed world. For instance, while India’s official government does a poor job dealing with trash, an informal trash economy has sprung up that successfully recycles 56 to 70 percent of the country’s recyclable material. In Europe and the United States, the amount is closer to 30 percent.

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Friday, January 11, 2013

Medical device makers rise after fiscal cliff deal

WASHINGTON -- Shares of medical device makers rose with the broader market Wednesday after Congress passed a bill to avoid the fiscal cliff which did not include a key provision sought by the industry.

Medical device makers seized on the fiscal cliff negotiations as perhaps their last chance to head off a 2.3 percent tax which took effect Jan. 1. The tax is aimed at high-end devices like pacemakers and CT scanners and is designed to raise over $29 billion in federal funds over the next decade. Companies like Medtronic Inc. have been lobbying against the tax since it passed with President Obama's health care overhaul in 2010.

An effort to block the tax got a boost earlier this month when 18 Senate Democrats signed a letter supporting a delay of its implementation. The Republic controlled House previously supported a full repeal of the tax.

But a provision delaying the device tax was not included in the last-minute package passed by House lawmakers late Tuesday. The narrowly tailored bill raises taxes on incomes exceeding $400,000 for individuals and $450,000 for couples, while continuing decade-old income tax cuts for everyone else.

Wells Fargo analyst Lawrence Biegelsen said Wednesday that ongoing negotiations between Congress and the White House, particularly over the nation's debt ceiling, could provide future opportunities to delay the device tax.

"However, the fact that a delay was not included in the end of year fiscal cliff agreement is clearly a setback and demonstrates how determined the proponents of the medical device tax _ and other taxes in the Affordable Care Act _ are to keep those taxes on the books," Biegelsen states in a note to investors. He adds that the likelihood of a complete repeal of the tax is "low at this point," and includes the cost of the measure in financial estimates for the coming year.

Shares of Minneapolis-based Medtronic, the world's largest medical implant maker, rose 53 cents, or 1.3 percent, to $41.55 in afternoon trading. Boston Scientific Corp. shares rose 10 cents, or 1.8 percent, to $5.83. St. Jude Medical rose 21 cents to $36.35.


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