Top Device Companies

Roche, IBM To Work On Lowering Genome Decoding Cost To Under $1,000

Roche has reached an agreement with IBM for joint development of genome-sequencing technology for enabling faster and cheaper DNA mapping. The project, expected to take several years, would build on IBM’s nanopore transistor intended to allow sequencing of each gene molecule as it passes through a nanosize pore in a silicon chip. Roche would participate through its sequencing unit, 454 Life Sciences, with the aim of bringing the cost of decoding an entire genome down to under $1,000. (Click here for more – a subscription may be required)

“Roche, IBM Enter Partnership On DNA Sequencing Technology” – Wall Street Journal (7/1/10)

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!

Roche Gets FDA Approval For More-Sensitive HIV Blood Test

Roche Diagnostic has received FDA approval for its COBAS AmpliPrep/Cobas TaqMan HIV-1 blood test, the company said. The test works by measuring the amount of HIV virus in a patient’s blood. With the test, Roche said, users can detect more genomic variants of the virus than capable with current tests. (Click here for more)

“Roche Says FDA Approves HIV Blood Test” – Bloomberg Businessweek (6/4/10)

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!

Roche Says FDA Clears Hepatitis C Test For Marketing In July

Roche says it has received pre-market approval from the FDA and expects to begin shipping its 18-minute in-vitro test for detecting hepatitis C. The FDA approval covers three platforms for the Elecsys Antibody anti-HCV test in human serum or plasma. One of the platforms is a stand-alone analyzer for low-volume testing. (Click here for more)

“Roche Wins Pre-Market FDA OK For Hepatitis Test” – Reuters (5/28/10)

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, Medtronic, J&J Others Seek To Sell Both Insulin And Devices

Abbott Laboratories, Medtronic and other large makers of insulin-delivery devices seek to cross the line into selling the insulin used in them. In addition To Abbott and Medtronic, other large players are Roche Holding, Johnson & Johnson and now Sanofi-Aventis, a drug maker about to cross the line from the other direction. The combination is considered vertical integration, usually made through a partnership with a firm that makes the other side of the combination. J&J already has several partnerships to combine insulin and a delivery device. (Click here for more – a subscription may be required)

“Pondering A Vertically Integrated Insulin Machine” – Wall Street Journal (3/28/10)

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, Roche, J&J Insulin Pumps Subject Of FDA Panel Concerns

Medtronic, Roche and Johnson & Johnson devices for delivering insulin are the subject of an FDA advisory panel set to look into several reports of problems. The panel of experts plans to discuss ways to lower the risks of implanted insulin pumps that are the subject of recalls. At risk, the FDA says, are Type I diabetics who rely on the pumps to deliver a daily dose of insulin in the place of shots. An FDA investigation uncovered 17,000 reports of adverse events related to the pumps between 2006 and 2009, 41 of them resulting in fatalities. (Click here for more – a subscription may be required)

“FDA Sees Increasing Number Of Insulin Pump Problems” – Wall Street Journal (3/3/10)

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!

Roche Diagnostics India To Partner With State, Local Governments

The Roche Diagnostics subsidiary in India, Roche Diagnostics India, plans to become a major seller of diagnostics in the country through partnerships with state and local governments. The intent of the partners in the plan is to get more medical diagnostics into the rural areas of the country. The proposed deal involving arrangements with several hospital groups would make Roche the first diagnostics maker to tap into the large rural Indian market. (Click here for more)

“Roche Plans To Tap Rural Market Via Public-Private Partnerships” – Livemint (1/1/10)

Hot Off the Presses: Medical Device Market 2009: Interventional Cardiology - This 86-page Special Report from IN VIVO identifies the most important trends in cardiology devices in recent years, teases out the critical decisions that drove those developments, and takes you behind the scenes and into the minds of the architects of these new technologies and business strategies. Find out more...

Roche Gets Emergency Clearance For H1N1 Flu Diagnostic

Roche won U.S. FDA emergency approval for a diagnostic test for the H1N1 flu virus. Roche’s device RealTime H1N1 is approved only for the duration of the health emergency declared because of the spread of the virus. Roche’s test now joins Gen-Probe and Quest Diagnostics products on the U.S. market. When the emergency is declared over, Roche would have to re-apply for full marketing approval. (Click here for more)

“Roche Says FDA Grants Approval For Swine Flu Test” – BusinessWeek (AP) (11/16/09)

Hot Off the Presses: Medical Device Market 2009: Interventional Cardiology - This 86-page Special Report from IN VIVO identifies the most important trends in cardiology devices in recent years, teases out the critical decisions that drove those developments, and takes you behind the scenes and into the minds of the architects of these new technologies and business strategies. Find out more...

Abbott, Siemens, Roche Heart Attack Tests Shown Superior

Abbott Laboratories, Siemens AG and Roche rapid blood tests for detecting a heart attack have been found effective, according to a newly published study. The new-generation tests are considered superior to sometimes inconclusive electrocardiograms to measure electrical activity in the heart and to test for troponin levels. With the Abbott, Siemens and Roche tests, physicians are able to act more quickly to determine if a patient needs emergency intervention. (Click here for more)

“New Blood Tests Find Heart Attacks Quicker, Better” – AP (8/26/09)

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Abbott, Roche Diabetes Test Strips Draw New FDA Warning

Abbott Laboratories and Roche Diagnostic diabetes test-strips have drawn an FDA warning about inaccurate results. Other makers of the tests also were part of the warning that the strips contain non-glucose sugars that can lead to false readings of elevated levels that could lead to insulin overdoses. The strips are used in combination with dialysis and other diabetic drugs. One of those drugs already carries a warning it could interfere with monitoring tests, but the FDA says they continue to be included in treatment despite earlier warnings about combining them. (Click here for more)

"FDA Warns Of Faulty Results With Blood Sugar Tests" - AP (8/15/09)

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Roche, Bayer Could Face Higher Standards For Blood-Glucose Monitors

Roche, Bayer and other makers of diabetes monitors may face added pressure to raise the standards for their products intended to help control glucose levels. At issue is the accuracy of the readings their monitors give, said in one government study of five monitors to vary by as much as 32 percent. Roche makes Accu-Check monitors for use by patients. A spokeswoman for the company noted that all blood-glucose monitors have a limitation or interference problem, such as with certain drugs the patient may be taking. A spokeswoman for Bayer, maker of Ascensia Breeze and Ascensia Breeze II, said to differ by an average of 62 points, said her company complies with government standards and would abide by changes. (Click here for more)

"Standards Might Rise On Monitors For Diabetics" – New York Times (7/18/09)

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