Yesterday I paid a visit to Precision Medical Products, a contract manufacturer located in Pennsylvania. It has a state-of-the-art 106,000 sq ft facility opened in 2005. It enables the firm to perform just about every function needed for medical device manufacturing (except sterilization) in-house. You'd expect something like this from a large company, but PMP is relatively small compared to some of its competitors. So how were they able to pull it off? The story is very interesting. A predecessor company had been the primary manufacturer of a special kind of needles used for the smallpox vaccine, until the disease was virtually wiped out in the 1970s. But after 9/11, bioterrorism concerns came to the forefront, and the U.S. government decided it needed safeguards against a potential smallpox outbreak. Indeed, it decided that it needed to stockpile one needle for every American citizen. So it went to PMP, and despite its small size, the firm figured...
November 21st, 2007
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As part of its strategy to further focus on its arthroscopy portfolio, Smith & Nephew Endoscopy is selling its vascular business. According to Joe Metzger, the company's spokesperson, the business segment has fewer than 20 employees and generates less than $5 million in annual sales. The Boston Globe is also reporting job cuts aren't planned. Investor group InaVein LLC picked up the vascular business for an undisclosed amount.
November 20th, 2007
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Boston Scientific and the ECRI Institute have read more >>
November 19th, 2007
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At least when it comes to treating abdominal aortic aneurysms (AAA). Did you know that deaths as a result of AAA are just as common as those from prostate and breast cancer? New tools are raising the bar in terms of what doctors can do, making good surgeons excellent and excellent surgeons phenomenal ones, according to Mark Farber, a physician who spoke at a media and investor event held by Cook Medical yesterday afternoon in New York City. Cook is one of three major companies leading the way in treating AAA. In fact, the company has exceeded its own expectations in global sales this year and now leads the worldwide market in endovascular aortic repair. By the end of the third quarter, Cook surpassed Gore and captured 40% of the U.S. market (Gore had 35% and Medtronic held 23%). In Europe, Cook took the top spot in AAA stent grafts at 42%. The company is working on several projects for its Zenith Endograft product family for 2008. We can expect to see several clinical trials, PMA...
November 16th, 2007
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Transforming FDA LogoFDA announced it is taking steps to improve how its advisory panels are conducted, in accordance with recommendations from the Institute of Medicine. One guidance document lays out how conflicts of interest will be disclosed from now on. All panelists must now publicly disclose any interests for which FDA has granted them a waiver. Another guidance recommends that panels adopt simultaneous voting, announce voting results immediately, and record how each member voted in the public record. Operating procedures for the panels have also been...
November 16th, 2007
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Stryker has agreed to pay $16.6 million to settle charges that its former outpatient therapy subsidiary submitted false claims to Medicare and other government programs, and kept excess or duplicate payments, reports Bloomberg News. The unit, Physiotherapy Associates inc., was accused of billing the government for services it didn't provide. $6 million of the settlement will go to two whistleblowers who brought lawsuits under the federal False Claims Act. The Justice Department attorney who oversaw the case said that "submitting false claims to our nation's health care programs is tantamount to stealing from the American taxpayer." We couldn't have said it better.
November 15th, 2007
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With all of the mergers and acquisitions that have taken place in the device world this year, news about device IPOs has been few and far between. But the Twin Cities saw two  yesterday, reports the Star Tribune of Minneapolis. EnteroMedics Inc., which is developing a device to treat obesity, raised about $40 million from the initial offering of 8 million shares. It had hoped to raise as much as $86 million. Its founder, Mark Knudson, has created a number of companies over the years, including Restore Medical, one of MD...
November 15th, 2007
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Ever since Johnson...
November 14th, 2007
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An editorial in a medical journal has revealed that St. Jude Medical's defibrillator leads perforated the hearts of four patients. The case studies, accompanied by an editorial, reportedly appeared on the Web site of Pacing and Clinical Electrophysiology (PACE). Despite this news, St. Jude is standing by its Riata leads and hasn't issued a recall on the product. The company instead responded by submitting an article to PACE, which is expected to appear in the journal's December issue. St. Jude's article points to data that the company hopes will affirm the strong performance of the Riata leads. According to the summary of the article, the occurence of perforations in the Riata product is "comparable or below" what has been seen for standard right ventricular pacing leads that are being followed in...
November 13th, 2007
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In today's New York Times, Barnaby Feder has read more >>
November 12th, 2007
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