Top Device Companies

Abbott Gets FDA Warning Letter Over Blood-Sugar Monitors

Abbott Laboratories received a warning from the FDA that its California plant for producing monitors of blood-sugar levels violate regulatory standards. FDA investigators reported that an inspection showed Abbott’s Freestyle and Navigator blood glucose-monitoring devices did not conform to quality manufacturing practices and thus were adulterated. An Abbott spokesman said the warning letter would not affect the continued marketing of the devices, and related only to the firm’s validation and documentation procedures. The spokesman said Abbott was taking corrective actions. (Click here for more)

“FDA Warns Abbott On Blood-Sugar Monitors” – Reuters (7/20/10)

Medical device manufacturers facing many challenges: from the rising clout of group purchasing organizations (GPOs) to payment bundling and physicians' growing allegiance with hospitals in product price negotiations. Get all the answers now in new Medtech Insight's new 24-page Special Report: Medical Device Landscape: How regulatory changes and cost control measures are reshaping the industry. Available for purchase now!

J&J, Covidien May Set Trend With Buys Of Neurovascular Firms

Johnson & Johnson and Coviden may be setting a new trend by buying smaller firms specializing in neuroscience products. Covidien bought ev3 for $2.6 billion just a year after ev3 itself bought the smaller Chestnut Medical Technologies for $26 million. While Covidien completed its ev3 purchase, J&J said it would buy Micrus Endovascular for $480 million. An analyst guessed that Boston Scientific’s neurovascular unit might be the next acquisition target and suggested Abbott Laboratories and Medtronic might have to buy other neuro assets to stay competitive. (Click here for more)

“Covidien, J&J Getting Into People’s Heads” – Investors Business Daily (7/16/10)

Medical device manufacturers facing many challenges: from the rising clout of group purchasing organizations (GPOs) to payment bundling and physicians' growing allegiance with hospitals in product price negotiations. Get all the answers now in new Medtech Insight's new 24-page Special Report: Medical Device Landscape: How regulatory changes and cost control measures are reshaping the industry. Available for purchase now!

Abbott Gets FDA Approval For Freestyle Diabetes Testing Strips

Abbott Laboratories won FDA approval for its diagnostic test for determining glucose levels in diabetes patients. The new Freestyle test involves testing strips that contain an enzyme that makes such tests more accurate. Abbott said that with the approval it expects to begin marketing the Freestyle test strips as early as August. (Click here for more)

“FDA OKs Abbott’s New Diabetes Testing Strips” – Boston Globe (6/24/10)

Medical device manufacturers facing many challenges: from the rising clout of group purchasing organizations (GPOs) to payment bundling and physicians' growing allegiance with hospitals in product price negotiations. Get all the answers now in new Medtech Insight's new 24-page Special Report: Medical Device Landscape: How regulatory changes and cost control measures are reshaping the industry. Available for purchase now!

Boston Sci Rearranges Credit To Pay Off Abbott, Other Debts

Boston Scientific plans to repay its $900 million debt to Abbott Laboratories through a $3 billion, three-year loan it arranged to extend a now-expired $1.75 billion line of credit. In addition to paying Abbott, Boston Sci expects to use the extra cash to pay off $850 million worth of other notes due next year. Like most of the medical device industry, the company is drawing on new credit arrangements to carry it through a period of declining sales until the economy improves. Boston Sci had the additional problem of a month-long freeze on selling its implantable defibrillators. (Click here for more – a subscription may be required)

“Boston Scientific Gets $3 Billion Loan, Credit Line To Repay Debt” – Wall Street Journal (6/23/10)

Medical device manufacturers facing many challenges: from the rising clout of group purchasing organizations (GPOs) to payment bundling and physicians' growing allegiance with hospitals in product price negotiations. Get all the answers now in new Medtech Insight's new 24-page Special Report: Medical Device Landscape: How regulatory changes and cost control measures are reshaping the industry. Available for purchase now!

Abbott Gets U.S. Clearance For Earlier HIV-Detection Test

Abbott Laboratories won FDA approval for its test designed to detect the HIV virus earlier in the infection stage, allowing greater control over its spread. Abbott said the test is able to detect at least 90 percent of early-stage HIV infections, allowing diagnosis and care to begin weeks earlier than allowed by current tests. The Abbott test, Architect HIV Ag/Ab Combo assay, already is available in Europe, where it is in common use in France and the United Kingdom. (Click here for more)

“FDA Approves More-Advanced HIV Test” – Reuters (6/21/10)

Medical device manufacturers facing many challenges: from the rising clout of group purchasing organizations (GPOs) to payment bundling and physicians' growing allegiance with hospitals in product price negotiations. Get all the answers now in new Medtech Insight's new 24-page Special Report: Medical Device Landscape: How regulatory changes and cost control measures are reshaping the industry. Available for purchase now!

GE, J&J, Abbott, Medtronic Lead Devices Lobbying Spree Early In Year

Abbott,Medtronic, Boston Scientific and other major device makers spent $20 million during the first quarter of this year lobbying in the nation’s capital. Filings the companies are required to make show General Electric alone contributed more than $7.1 million while a proposal to increase taxes on medical devices was being considered by Congress. Johnson & Johnson spent $2.4 million, Abbott Laboratories more than $1.8 million, Medtronic and Baxter Healthcare more than $1.2 million each, while Boston Scientific reported spending only $605,000 during the period. (Click here for more)

“Medical Device Makers’ Lobby Bill: $20 Million” – MedCity News (6/14/10)

Medical device manufacturers facing many challenges: from the rising clout of group purchasing organizations (GPOs) to payment bundling and physicians' growing allegiance with hospitals in product price negotiations. Get all the answers now in new Medtech Insight's new 24-page Special Report: Medical Device Landscape: How regulatory changes and cost control measures are reshaping the industry. Available for purchase now!

Abbott Gets FDA Clearance To Market Ovarian Cancer Blood Test

Abbott Laboratories won clearance to place another blood test for ovarian cancer on the U.S. market. The test is called Architect HE4, capable of monitoring ovarian cancer, either its recurrence or progression. The Abbott test is considered an advancement of the current common test, CA125, which relies on measurements of protein levels in blood. Abbott promotes using its new test in conjunction with the old one so physicians can have a more comprehensive view of the cancer. (Click here for more)

“Abbott Laboratories Gets FDA Approval For Architect HE4 Blood Test For Ovarian Cancer” – Canadian Business (6/3/10)

Medical device manufacturers facing many challenges: from the rising clout of group purchasing organizations (GPOs) to payment bundling and physicians' growing allegiance with hospitals in product price negotiations. Get all the answers now in new Medtech Insight's new 24-page Special Report: Medical Device Landscape: How regulatory changes and cost control measures are reshaping the industry. Available for purchase now!

Abbott Gets EU Clearance For Trek Heart-Artery Cleaning Device

Abbott Laboratories says it has been cleared to market its Trek Coronary Dialatation Catheter in the European Union. The Trek system is designed for use in treating lesions and hard-to-reach blockages in coronary arteries before a stent is implanted. The system also can be used after a stent implant, a spokesman said. The system, which has yet to receive U.S. approval, is available in 77 sizes and several diameters, Abbott said. (Click here for more)

“Abbott Receives European OK For Trek Catheter” – Bloomberg Businessweek (AP) (5/26/10)

Medical device manufacturers facing many challenges: from the rising clout of group purchasing organizations (GPOs) to payment bundling and physicians' growing allegiance with hospitals in product price negotiations. Get all the answers now in new Medtech Insight's new 24-page Special Report: Medical Device Landscape: How regulatory changes and cost control measures are reshaping the industry. Available for purchase now!

Abbott Reports Two-Year Durability Of MitraClip Mitral Valve Repair

Abbott Laboratories reports a study of its MitraClip mitral valve repairer has demonstrated in a U.S. study to be as durable as surgical repair two years later. The minimally invasive technique to repair the most common heart-valve problem is under review in the United States, but already on the market in Europe. The repair is for mitral regurgitation, which affects more than 8 million in Europe and the United States combined. (Click here for more)

“Abbott Heart Valve Clip Effective After Two Years: Study” – Reuters (5/25/10

Medical device manufacturers facing many challenges: from the rising clout of group purchasing organizations (GPOs) to payment bundling and physicians' growing allegiance with hospitals in product price negotiations. Get all the answers now in new Medtech Insight's new 24-page Special Report: Medical Device Landscape: How regulatory changes and cost control measures are reshaping the industry. Available for purchase now!

Medtronic, Abbott Heart Stents Similarly Safe, Effective In Trial

The heart stents of Medtronic and Abbott Laboratories had similar results during testing on high-risk patients taking part in a comparative trial. Medtronic said the study showed its Resolute drug-eluting stent was linked to a similar number of deaths, heart attacks and repeat procedures as Abbott’s Xience. The difference between the two in measuring adverse events was only a tenth of 1 percent, Medtronic said. The study was carried out on 2,292 patients in Europe. (Click here for more)

“Medtronic Resolute Stent Matches Abbott’s In Study” – Reuters (5/25/10)

Medical device manufacturers facing many challenges: from the rising clout of group purchasing organizations (GPOs) to payment bundling and physicians' growing allegiance with hospitals in product price negotiations. Get all the answers now in new Medtech Insight's new 24-page Special Report: Medical Device Landscape: How regulatory changes and cost control measures are reshaping the industry. Available for purchase now!