One of the reasons Cook Medical (Bloomington, IN) is doing so well is the fact that most of its technologies are used in procedures that aren't elective. Yesterday the company held what has become an annual meeting for the media and analysts during the week of VEITH, a symposium for vascular surgeons and cardiologists in New York City. Cook Medical achieved double-digit growth and reached $1.5 billion in annual sales, and is continuing to build up its global reach with several manufacturing facility expansions and worldwide product launches. This year, the company made significant investments in its manufacturing sites in Ireland ($25 million euros), Australia, Denmark, and Shanghai, and is expanding Cook Pharmica by 100% and Cook Urological by 50%. Cook also opened new offices in Japan and acquired shonin, which enables the sale of the company's products in that country. The meeting focused on Cook's Peripheral...
November 21st, 2008
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John Dingell (D-MI) has been replaced as chair of the House Energy and Commerce committee by Representative Henry Waxman of California, reports Los Angeles Times's Janet Hook. Hook says that the regime change has come because House Democrats are unhappy with Dingell's defense of the auto industry. Waxman has a much stronger stance on global warming than Dingell. To the device and other medical industries, however, the change may mean an even higher level of scrutiny from the Hill. Waxman is notoriously critical of the pharmaceutical industry, and, to an only slightly lesser degree, the medical device industry. Waxman's promotion to chairman was the result of a vote during a closed meeting of the Caucus. The committee approved Waxman, 137 to 122. This change upsets the seniority system of the House.
November 20th, 2008
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Yesterday GE Healthcare announced three IT initiatives that it is confident will improve patient care while driving down costs. At a media event in New York City, GE's top healthcare officers, along with industry leaders, provided the framework for its plans, as well as some insight on where and how they fit into the global market. GE's IT Initiatives 1. Digital from Day One. The initiative provides the tools for a completely digital operation, from patient check in to electronic medical records. It will also be present at developing hospitals in emerging countries. For example, Aspetar Hospital in Qatar is one of the first sites partnering with GE on the solution. The company's goal is to implement the program into more than 3000 doctor offices and new hospitals through 2012, giving access to a global network of healthcare groups. According to the president and CEO of GE Healthcare IT, Vishal Wanchoo,...
November 19th, 2008
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Top management at FDA is being accused of corruption by scientists in a letter. It says that managers interfered with scientists responsibilities to ensure the safety and efficacy of medical devices. According to the letter, "misconduct reaches the highest levels of CDRH management including the Center Director and Director of the ODE." The accusations of coercion and intimidation have led Representatives John Dingell (D-MI) and Bart Stupak (D-MI) of the House Energy and Commerce Committee to begin a congressional investigation. They believe FDA experts were "ordered, intimidated, and coerced" to modify scientific reviews, conclusions, and recommendations on devices. The scientists claim they were forced to accept data that wasn't scientifically valid. Bloomberg News...
November 18th, 2008
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MassMEDIC's 10th Annual MedTech Investors Conference showcased a range of devices from 25 start-up companies. Innovations included a line of knee implants and instrumentation that provide a minimally invasive alternative to conventional knee replacement surgery from Conformis Inc. (Burlington, MA), and a noninvasive body scanner that detects and measures, pain and injury, while identifying the tissue involved from Signal Insight Inc. (Freeport, ME). Other Massachusetts companies that displayed their technologies included the Institution for Pediatric Innovation Inc. (Cambridge), Smart Surfaces Inc. (Somerville), NMT Medical Inc. (Boston), and Confidisc Medical (Southampton). More than 400 venture capitalists and medical device business leaders attended the MassMEDIC event, which was held on Friday. Massachusetts has the second largest concentration of medical device development and manufacturing in the country. The state is home to more than...
November 17th, 2008
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Image courtesy of William Paul Segars of Johns Hopkins In Poe's "The Telltale Heart," an imagined heartbeat drives a murderer to confess his crimes. The heart is powerful in literature, but it is even moreso in reality. Its so powerful, in fact, that its energy can be used to run implanted devices. A UK-based consortium of companies announced it has successfully designed and clinically tested an in-body model microgenerator that converts energy from the heartbeat into power for implanted medical devices. The Self-Energizing Implantable Medical Microsystem (SIMM) augments existing battery for devices such as pacemakers, and implanted cardioverter defibrillators. In preclinical...
November 11th, 2008
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A new president will undoubtedly bring change in some form, but what does this mean for the medical device industry? Unfortunately, we all know that the same issues and problems won't instantly disappear. Healthcare reform, inadequate FDA funding (challenged further by the rising deficit and financial crisis), reimbursement, product safety and liability lawsuits, user fees--the list of challenges you face continues. The device industry has mane concerns, but changes will happen under President-elect Barack Obama's watch? The industry is already abuzz with speculations about who will be nominated for the position of FDA commissioner. Among the numerous rumored candidates are Steven Nissen, MD, chair of the department of cardiovascular medicine at The Cleveland Clinic; Susan Wood, PhD, former director of FDA's Office of Women's Health; and Josh Sharfstein, a licensed pediatrician and the commissioner of Baltimore's public health department (along with being former staffer to Oversight...
November 10th, 2008
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For election cycle 2008, medical device companies* seemed nearly equally split across party lines. The table below was adapted from data found at OpenSecrets.org. It features the top 20 contributors in industry, broken down by amount given to different organizations. Please note, MD&DI in no way endorses any party or candidate. The data presented here is for informative purposes only. ...
Rank Organization Amount Dems Repubs
1 Medtronic Inc $441,210 58% 42%
2 Boston Scientific Corp $338,083 38% 62%
3 C8 Medisensors $262,124 100% 0%
4 Baxter International $235,264 53% 47%
November 5th, 2008
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FDA News: Abbott has filed a lawsuit against Medtronic for infringing on its patent for the Rapid Exchange system. The lawsuit comes on the heels of Medtronic’s announcement that it is launching its Endeavor drug-eluting stent and other angioplasty products in the U.S. on the Rapid Exchange delivery system, which it anticipates will increase use of its devices, Medtronic says. Abbott says its Xience V drug-eluting stent has rapidly become the U.S. market leader. It does not expect Medtronic’s launch of a new delivery system to change market dynamics.

November 5th, 2008
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A device that a company claimed could be used to treat or cure cancer, depression, infection, and pain is being recalled. The Vibrational Integrated Biophotonic Energizer (VIBE) machine was never approved by FDA, and the manufacturer, VIBE Technologies (Greeley, CO), received a warning letter about the issue in April. The company sent a certified letter to customers who bought the device, informing them to stop using it. Customers were also told to sign the certification to acknowledge that they received the warning, which instructed them to attach a label to the machine stating it isn't a medical device and shouldn't be used as one. The letter asked customers to cease promoting the machine as a medical device and remove medical claims about the product from their Web sites. The site www.vibemachine.com states it is...
November 3rd, 2008
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