Shelhigh Inc., which had its inventory of tissue-based implants seized by the government because of concerns over sterility, has gone to court to get them back, but the judge says he's not inclined to grant the company's wish, reports the Star-Ledger of Newark. The firm argues that it should be allowed to ship the products overseas because GMPs don't apply to products made for export. U.S. District Judge William J. Martini said he does not agree with that interpretation, but is giving Shelhigh more time to collect additional evidence. The company says it will likely be forced out of business if it can't sell the seized product. Update: On May 18 FDA issued a preliminary public health advisory about possible contamination of Shelhigh devices.
May 16th, 2007
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Bausch...
May 16th, 2007
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Tyco International Ltd. and Siemens, two multinational conglomerates that have been embroiled in corporate scandals, saw steps taken to resolve the controversies. Both companies have medical divsions that could be affected by the fallout. Tyco this morning announced it will pay nearly $3 billion to settle claims filed by shareholders in the wake of misconduct by top executives, some of whom were convicted of defrauding the company to line their own pockets. It is the largest-ever settlement by a single corporate defendant in a class-action suit, reports the Associated Press. Tyco is spinning off its healthcare division, which will be called Covidien. Siemens yesterday saw two former executives convicted of bribery, reports the New York Times. As part of the judgment, the...
May 15th, 2007
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Cardinal Health today announced plans to buy Viasys Healthcare for about $1.5 billion. Viasys, known for its rapid product innovation and fast growth, plays in a number of markets, including disposables, orthopedics, and respiratory. It was named one of MD&DI's 50 Companies to Watch in June 2006. This is the latest step in Cardinal's plan to move from being a distributor to being a major manufacturer as well. Its previous biggest splash was buying Alaris Medical Systems in 2004.
May 14th, 2007
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Transforming FDA LogoCDRH has unveiled two pathways to facilitate electronic Medical Device Reporting. This will hopefully increase the volume of MDRs, which are underreported. Small manufacturers who don't anticipate making many MDRs can use a program called CDRH eSubmitter, or CeSub. To use it, they can download special software, which runs on a PC and allows users to submit one report at a time. Large manufacturers, who may need to submit hundreds of reports per year, can use a batch submission protocol in accordance with the health informatics standard known as HL7. An information guide on HL7 can be obtained by emailing...
May 14th, 2007
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In today's world, it's no surprise that device companies are trying to develop products that will help protect the public in the event of a biologic (or nuclear) disaster. On Tuesday, FDA approved two filtering facepiece respirators that help reduce exposure to airborne germs in the case of a public health emergency. Manufactured by 3M Co. (St. Paul, MN), the devices are N95 certified, which means they meet certain criteria set forth by the National Institute for Occupational Safety and Health (NIOSH). The mask, which fits tightly over the nose and mouth, is supposed to filter out at least 95% of small airborne particles. Although they don't require a prescription, N95 respirators must be properly fitted to each person if they were to be used in the workplace by healthcare workers, for example. FDA requires that companies marketing these kinds of devices during health emergencies must ensure they are certified by...
May 11th, 2007
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Transforming FDA LogoThe Senate yesterday passed the FDA Revitalization Act, which includes the new version of MDUFMA, 93-1. The bill is getting more coverage in the media for its drug-industry reforms, particularly concerning safety issues, read more >>
May 10th, 2007
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The Record of Hackensack, NJ has a piece this morning that spotlights some northern New Jersey device firms that received venture capital funding in the first quarter of 2007. It contains interviews with executives from Circulite Inc. (Hackensack), which makes a device to treat heart failure, and Cadent Holdings Inc. (Carlstadt, NJ), which makes dentistry and orthodontic imaging devices. Also mentioned are Regen Biologics Inc. (Franklin Lakes, NJ; orthopedic implants) and Multispectral Imaging Inc. (Parsippany, NJ; infrared sensor devices). While the angle of the article, written by Douglass Crouse, is a financial one, it does a good job of showing that medical technology innovation can't happen without small companies, and the backers who fund them. A Circulite executive who used to scout potential acquisitions for large...
May 10th, 2007
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The federal antikickback investigation against five orthopedics manufacturers could end as soon as this summer, reports the Star-Ledger of Newark, NJ. Apparently four of the firms -- Biomet, Smith...
May 9th, 2007
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Not long after a study questioned whether angioplasty is really needed, another says that, for patients who have suffered a certain kind of heart attack, the answer is yes, reports Bloomberg News. A piece published in the Journal of the American Medical Association found that angioplasty is better than drugs for patients who suffered silent ischemia, in which blood flow is obstructed without noticeable symptoms. Patients treated with angioplasty suffered a repeat attack 6.3% less often than those treated with drugs.
May 9th, 2007
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