Top Device Companies

Boston Sci, Medtronic, Baxter, Stryker Rely On European Device Sales

Boston Scientific, Medtronic, Baxter International and other major device makers depended during the previous quarter on the effect of Europe’s recession. Those three and Stryker are large exporters of medical devices to Europe and were expected to report quarterly earnings largely affected by those foreign sales. Boston Sci and Medtronic also were expected to be affected by the former’s problems with implantable defibrillators and Medtronic’s efforts to fill the sales gap after the Boston Sci devices were recalled. (Click here for more – a subscription may be required)

“Earnings Preview: For U.S. Medical Device Companies, Focus Is Europe” – Wall Street Journal (7/14/10)

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!

Baxter Gets FDA Advice On Returning Infusion Pumps To Market

Baxter International has been told by the FDA how it can bring its Colleague infusion pumps into compliance with regulations. But the same instructions told Baxter it must recall the 200,000 pumps at issue and either replace those still on the market or refund their costs. The agency ordered Baxter two months ago to stop marketing Colleague, which has been linked to 500 deaths and 56,000 adverse-event cases. (Click here for more)

“Baxter Is Back After Clearing The Air With FDA” – Minyanville (7/14/10)

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!

Baxter Ordered By FDA To Recall Infusion Pumps, Refund Costs

Baxter International’s decision to make “field corrections” on its Colleague infusion pumps has led to a recall ordered by the FDA. The agency rejected the timeline Baxter offered when it announced the proposed fixes, saying it could not accept the company’s plans to complete the corrections next year. About 200,000 pumps, most of them in hospitals, are affected by the recall. The FDA ordered Baxter to recall all pumps now in use and either give customers a refund or replace the device without cost. (Click here for more)

“FDA Orders Baxter To Recall Infusion Pumps” – New York Times (7/13/10)

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!

Baxter Warned By FDA Over Procedural Lapses With Dialysis Devices

Baxter International was handed a warning letter by the FDA, saying the company failed to investigate or report properly some problems with its dialysis devices. The letter was issued after an inspection of Baxter’s Illinois facilities revealed the failures. Device makers are required to report adverse events with products within 30 days, but the FDA said Baxter did not do so and also did not report some side effects connected with the devices. Baxter said it already has changed its processes to comply with FDA rules. (Click here for more)

“FDA Warns Baxter On Failures To Properly Report, Probe Dialysis Device Problems” – Wall Street Journal (6/29/10

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, Baxter Among Device Makers Hit By Europe Health-Care Cuts

Abbott Laboratories and Baxter Laboratories are two of many U.S. businesses in several industries expected to be hit hard by Europe’s economic crisis centered around Greece, Spain, Portugal and Italy. All four countries are dealing with cost-cutting efforts to bring their economies under control, and some of those cuts are in coverage and purchase of health care products such as medical devices. Most of the rest of the European governments also are cutting back on health care expenditures to reduce their deficits. (Click here for more)

“European Crisis Could Hit Sales At Kraft, Abbott, McDonald’s, Others” – Chicago Business (5/17/10)

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!

Baxter, Partner Halozyme Recall Pediatric Device Over Glass Particles

Baxter International is ordering a recall along with its Halozyme Therapeutics partner of their Hylenex device used to treat dehydration in youngsters. The companies said glass particles have been discovered in vials used in the devices. In a joint news release, Baxter and Halozyme said no adverse events have been reported even though about 3,500 vials have entered the market. They said the glass particles were discovered during stability testing in a few of the vials. A Baxter facility produces the Hylenex. (Click here for more – a subscription may be required)

“Baxter, Halozyme Recall Hylenex Over Glass Flakes” – Wall Street Journal (5/17/10)

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!

Baxter Ordered To Recall, Destroy All Colleague Pumps In U.S.

Baxter International was ordered by the FDA to recall and destroy all 200,000 of its Colleague infusion pumps. The devices, which deliver drugs and fluids intravenously, were termed by the FDA as victims of Baxter’s “longstanding failure” to fix their serious problems. Baxter also was ordered to give refunds or replacement pumps gratis. Baxter estimates the recall cost at as much as $600 million for the first three months of the recall. (Click here for more)

“FDA Orders Recall Of Baxter Infusion Pumps” – New York Times (5/3/10)

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!

Baxter, Other Infusion Pumps Subject Of FDA Probe Following Deaths

Baxter Healthcare, Hospira and CareFusion could face more strict FDA control over their infusion pumps, including more trial data before getting approval. The agency said 710 deaths associated with pump problems have been reported to the agency over the past five years, and there may be more. Some of the deaths occurred after patients received drug overdoses through the pumps. The FDA is investigating to see whether hospital workers entered incorrect data into the devices or the software malfunctioned. (Click here for more)

“FDA Steps Up Oversight Of Infusion Pumps” – New York Times (4/23/10)

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!

Baxter’s Cash Reserves Prime Firm For M&A Deals, CEO Says

Baxter International CEO Robert Parkinson says the firm is considering use of its $2.7 billion in cash reserves for mergers or acquisitions. He said he is spending an increasing amount of his time on M&A possibilities, but is not about to make deals just for the sake of doing so. Baxter’s current financial status, he said, gives it the financial latitude to make a deal when the right possibility presents itself. But he added that he and the board are determined to remain disciplined in making those decisions. (Click here for more)

“On The Call: Baxter CEO ‘Receptive’ To M&A Options” – Business Week (AP) (4/22/10)

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!