FDA has issued an updated guidance document on medical device tracking, superceding one written less than a year ago. The main change is that it adds cultured epidermal autografts to the list of devices that must be tracked. Upon request, manufacturers subject to tracking requirements must produce information to FDA within 3 days about devices not yet distributed to patients, and within 10 business days about ones that have been.
November 5th, 2007
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The big five orthopedic manufacturers under scrutiny from the NJ U.S. attorney's office have paid more than $200 million to doctors and hospitals this year alone, according to estimates made by the Associated Press. The settlement made by Biomet, De Puy Orthopaedics, Smith...
November 2nd, 2007
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Boston Scientific received a major setback in its lawsuit against rival Johnson...
November 1st, 2007
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The share price of American Medical Systems Holdings Inc. (Minnetonka, MN) took a pounding yesterday over concerns about problems with integrating Laserscope, a company it bought last year, reports the Star Tribune of Minneapolis. After the firm announced it is cutting its 2007 sales and profit forecasts, Wall Street analysts downgraded its stock, and the price promptly fell by 29%, the largest one-day drop in company history. The main problem appears to be a failure to properly integrate Laserscope's sales force into American Medical Systems. If your sales force isn't functional, you're simply not going to get the revenues and profits you want. This should be a lesson to all firms that are considering an acquisition that might be biting off more than it can chew.
October 31st, 2007
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The New York Times today has an read more >>
October 30th, 2007
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Private equity firm Warburg Pincus has completed its $3.7 billion buyout of ophthalmics giant Bausch & Lomb, reports the Associated Press. Eye-care rival Advanced Medical Optics had made a $4.2 billion offer, but pulled it in August after accusing Bausch & Lomb of putting up insurmountable hurdles to approval. Like Boston Scientific with Guidant, however, Warburg Pincus acquires problems as well as prestige with the Bausch & Lomb deal. B&L is still feeling the fallout from a May 2006 contact-lens-solution recall, and it has been named as a defendant in about 550 product-liability lawsuits. At least the firm won't be pressured by Wall Street analysts and shareholders as it tries to work through the problems.
October 29th, 2007
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A study published in the October issue of Brain used MRI technology to measure structural changes that occur in the brain following injury. More specifically, the researchers used diffusion tension imaging to observe the integrity of the brain's white matter. They were able to link structural changes in this area to cognitive deficits related to thinking, memory, and attention. The technology could prove to be a useful tool in assessing injuries that occur in athletes as well as in the battlefield.
October 26th, 2007
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MD&DI has named Integra LifeSciences Corp. (Plainsboro, NJ) and Intuitive Surgical Inc. (Sunnyvale, CA) as its 2007 Medical Manufacturers of the Year. Profiles of both companies appear in MD&DI's November 2007 issue. Integra, which makes regenerative-medicine and neurosurgical products, and Intuitive, which makes robotic-assisted surgery systems, were honored for developing extraordinarily innovative technologies and building successful businesses around them.
October 25th, 2007
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Angstrom Medica, Inc. (Woburn, MA), which claims to have been the first firm to get a nanotechnology medical device approved by FDA, has been acquired by Pioneer Surgical Technology (PST; Marquette, MI), according to a release posted on devicelink.com. Terms of the deal were not disclosed. Angstrom will become a subsidiary of PST, and part of its orthobiologics division. Angstrom's NanOss uses nanotechnology to enable products that are highly osteoconductive and can remodel over time into human bone. NanOss, like human bone, is made of hydroxyapatite crystals. By controlling the material at the nanocrystalline level the resulting compound can have the strength of established polymer surgical implants.
October 25th, 2007
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Earlier this month, Covidien granted the University of Missouri-Columbia's School of Medicine $750,000 to come up with safer hernia-surgery procedures that could result in easier recovery for patients. The funds will help develop a materials characterization laboratory, where researchers will study materials typically implanted during procedures to repair abdominal hernias. Surgeons currently use a 50-year-old procedure in which propylene mesh is inserted to patch the hernia. Propylene is preferred because it is linked to low occurrences of infection and other complications, but it does not remain stable once implanted. So researchers at the university's Biodesign and Innovation Program will study why the mesh changes size, shape, and even color once implanted, and how to prevent that. Changes associated with other materials will also be investigated.
October 24th, 2007
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