Top Device Companies

Medtronic Wins FDA Panel’s Narrow Recommendation For Approval

Medtronic’s Amplify spine device squeaked through an FDA panel’s review, winning a 6-5 decision for recommending approval. The agency had raised questions earlier about a greater rate of cancer cases among patients treated with the device to stabilize the lower back. The device is designed to treat degenerative disc disease by using two recombinant bone morphogenetic proteins to help form new bone. One of the proteins is used in Medtronic’s already-approved Infuse, but that device and Amplify do not work in the same manner. The advisers’ votes were taken on whether the device’s benefits outweigh its risks. (Click here for more – a subscription may be required)

“FDA Panel Splits On Benefits, Risks Of Medtronic Spine Device” – Wall Street Journal (7/27/10)

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!

Hologic To Get September FDA Review For 3-D Mammography Device

Hologic’s 3-D mammography system is set for review by the FDA in September, boosting the company’s hopes for a device it expects to be a big seller. An FDA meeting has been scheduled for Sept. 24 to review the Silenia Dimensions 3-D mammography system that offers a new way to screen for and diagnosis breast cancer. The announced schedule means Hologic could have its device on the market by the end of 2011. The device already is marketed in more than a dozen countries, including those in Europe and in the Middle East. (Click here for more – a subscription may be required)

“FDA Panel Sets Date To Review Hologic’s 3-D Mammography System” – Wall Street Journal (7/27/10)

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!

Thoratec Sale Of ITC Unit To Danaher Falls When FDA Delays Action

Thoratec has dropped its effort to sell its International Technidyne subsidiary to Danaher. Thoratec said it canceled the deal when it failed to reach agreement with the prospective buyer, Danaher. The division had an asking price of $110 million. The two parties canceled the deal after disputes arose concerning ITC’s quality system and regulatory filings, Thoratec said. Some of the conditions of the sale rested on the FDA approving ITC’s ProTime InRhythm blood test by a certain date the FDA failed to meet. (Click here for more)

"Thoratec Abandons $110 Million Sale Of ITC Unit” – San Francisco Business Times (7/27/10)

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 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!

GE, Nihon Defibrillator Marketers Hit By Ordered Replacement Of 24,000

GE Healthcare and Nihon Kohden defibrillators, which they market for Cardiac Science, are considered defective and must be replaced, Cardiac said. At issue are 24,000 defibrillators with flawed electrical components that could cause the devices to fail. The FDA advised Cardiac the problem could not be fixed with software patches, so the company plans to replace the 24,000 sold to police and fire departments, hospitals and clinics. Other owners of the estimated 280,000 external defibrillators on the market are to be advised to continue using theirs until a replacement is available. (Click here for more)

“Cardiac Science To Replace 24,000 Defective Defibrillators” – Mass Device (7/19/10)

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!

Bayer, Duramed IUDs Subject Of Physician Import Scandal

Bayer and Duramed Pharmaceuticals interuterine devices are being obtained at a lower cost around the country as physicians buy imported versions from Canada for half the U.S. price. Bayer makes the Mirena hormonal IUD, which costs $700 in the United States, $320 in Canada. Duramed’s Paragard copper IUD, the only other IUD approved by the FDA, has a similar price differential because Canadian agencies bargain for discounts while U.S. agencies are barred by law from doing so. It also is against U.S. law to import devices that reached the market under the regulations of another country. (Click here for more)

“Rhode Island IUD Scandal Tip Of Iceberg” – Providence Journal (7/18/10)

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!

Boston Scientific Begins Trial Process For New Defibrillator Version

Boston Scientific has begun enrolling participants for a cinical trial of a new version of cardiac defibrillator, a device that has caused the firm problems. The latest product is the Cognis version relying on the firm’s Latitude patient-management system to allow the device to communicate with a physician. Boston Scientific had to stop producing and recall unimplanted defibrillators earlier this year after acknowledging to the FDA it failed to follow proper reporting procedures. (Click here for more)

“Boston Scientific Starts Cognis Clinical Trial” – MedCity News (7/8/10)

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!

Alcon To Offer $361.5 Million For LenSX Lasers, Cataract Surgery Leader

Alcon said it plans to acquire LenSx Lasers for $361.5 million to get its technology for improving cataract removal. Alcon itself is scheduled to be taken over later this year by Novartis, a Switzerland-based drug maker. LenSx’s “femtosecond” laser technology received the FDA’s first approval of such lasers for removing cataracts. The Alcon offer could reach $382.5 million if LenSx meets certain conditions, such as reaching revenue milestones. (Click here for more)

“Alcon To Buy Laser-Surgery Firm LenSx For $362 Million” – Reuters (7/6/10)

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!