Top Device Companies

BD, Abaxis Sign 10-Year, $30 Million Renewal Of Supplies For Test Devices

Becton, Dickinson signed a 10-year agreement with Abaxis to for its supply of chemical beads used in BD’s portable devices for analyzing blood. The $30 million contract replaces a just-expired five-year version for the same supplies. The Abaxis beads are soluble and react to blood. The chemical beads  can be used in different types of medical or laboratory technology. (Click here for more)

“Abaxis Inks Supply Deal With Becton, Dickinson Worth $30 Million” – San Francisco Business Times (1/25/11)

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!

Cordis Decline In Stent Sales, DePuy Problems No Help To Ailing Parent J&J

Cordis Group, a medical-device unit of Johnson & Johnson, reported its sales last year declined by nearly a third, adding to the parent company’s problems with drug recalls and suits over its DePuy subisidary’s hip implants. Cordis produces drug-eluting stents, led by its Cypher device, that achieved only $134 million in global sales last year, down 28 percent from $223 million the previous year. DePuy sales suffered because of earlier problems with its ASR hip implant. (Click here for more)

“Medical Device Unit Can’t Overcome JNJ Recall Woes” – Mass Device (1/25/11)

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!

Philips, Other Defibrillator Makers May Face Harsher FDA Safety Standards

Philips Medical Systems and other makers of external heart defibrillators were urged by an FDA advisory panel to have the products subjected to greater oversight. Philips and the other makers wanted to FDA to maintain the current classification for the devices as low-risk, the ranking given when they were first approved. The agency now classifies them as high risk, but the previous classification was grandfathered in regulations. The advisory panel of outside experts recommended greater control, given concerns about quality and reliability of the widely distributed defibrillators the subject of more than 22,00 reports of malfunctions and 68 recalls. An earlier staff report proposed requiring more data and additional manufacturing inspections before a new defibrillator can be brought to the market. (Click here for more)

“Stricter Oversight Urged For Defibrillators” – New York Times (1/25/11)

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 Lab’s Carotid Stent Gets FDA Staff Backing For Expanded Uses

Abbott Laboratories’s carotid stent appears to have cleared the first hurdle in receiving FDA approval for use in patients other than those unable to undergo surgery. An agency staff report, normally issued ahead of an advisory panel meeting, said clinical trials met criteria for being considered for expanded indications. An earlier study found the stents as safe and effective as surgery. (Click here for more)

“Abbott’s Neck Stent Met Primary Study Goals, FDA Says” – Bloomberg (1/24/11)

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, Medtronic, St. Jude ICDs Part Of Justice Probe Of Overuse

Boston Scientific, Medtronic, St. Jude Medical and other makers of implantable heart defibrillators could face even more bad news as the Justice Department checks on use guidelines. The Heart Rhythm Society said it is advising the department on the proper guidelines for making clinical decisions for implanting the devices. Implanted cardioverter defibrillators suffered a blow recently when a medical journal said nearly a quarter of the devices were implanted in people who did not meet the guidelines. (Click here for more)

“Group Helps Justice Department In Heart-Device Probe” – Reuters (1/24/11)

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, Edwards Transcatheter Valves Receive Favorable Study Reports

Medtronic’s and Edwards Lifesciences’s transcatheter valves received impressive support in recent trials, improving the chances of both devices to debut on the U.S. market. The Edwards Sapien device in clinical trials showed it provided significant and sustained improvements in quality of life of patients for as long as a year after implantation and that the patients can live well. Edwards is designing trials for its next version, its Sapien XT, which is to face a comparative trial with the current Sapien. Meanwhile, Medtronic has a study underway of its similar CoreValve device. (Click here for more)

“Favorable Transcatheter Valve Data Translate To Bright Prospects For Edwards And Medtronic” – Toronto Star (1/24/11)

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!

St. Jude Wins Australia Approval For Deep-Brain Stimulation Device

St. Jude Medical said Australian regulators have cleared its Athena deep brain stimulation programming device for that market. St. Jude earlier won approval in Europe where the device had just been launched. The device is used with three of St. Jude’s already-approved systems, its Libra, LibraXP and Bio DBS. The St. Jude devices work by sending electrical stimulation to the parts of the brain associated with Parkinson’s disease. (Click here for more)

“St. Jude Medical To Sell Deep-Brain Stimulation Device In Australia” – MedCity News (1/24/11)

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!

Stryker Plans To Continue Expanding Through Acquisitions, CEO Says

Stryker is said to have a pile of cash available for additional acquisitions beyond its recent $1.5 purchase of Boston Scientific’s neurovascular business. Stryker already had been expanding beyond its core business, but its acquisitions had consisted of smaller firms such as Gaymar Industries and Porex Surgical products. Addressing concerns Stryker may be expanding beyond its expertise, CEO Stephen MacMillan said the diversification was nothing new, that the firm has been doing so since its beginning. (Click here for more)

“Analysis: Stryker Seeks Growth Beyond Hips, Knees” – Reuters (1/24/11)

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!

C.R. Bard, Covidien Win Split Decisions In Suits Over Surgical Fasteners

C.R. Bard’s patent-infringement fight with Covidien took a new turn when a federal judge ruled Covidien’s Surgical Helical Fastener with Applicator was mis-labeled as being patented. But the same court granted Covidien’s motion to dismiss a charge it double-patented the devices to extend the original patent’s life. Covidien had sued C.R. Bard alleging its Sorbafix and Permafix fasteners infringed on that patent. Bard countersued, alleging Covidien’s Absorba Tack was falsely marked with the patent. (Click here for more)

“Covidien And Bard Split Latest Round Of Patent Fight” – Mass Device (1/24/11)

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 To Close Ireland Plant To Rid Bacteria From Dialysis Solutions

Baxter International said would close its Ireland production plant while it determines the source of harmful substances in dialysis solutions. Endotoxins were discovered in December in the peritoneal dialysis solutions Dianeal, Extraneal and Nutrineal. The company said it found the problem during routine testing of two tanks that had microscopic cracks where bacteria were located. The company said it has yet to eliminate the endotoxins, so it would close the plant temporarily. (Click here for more – a subscription may be required)

“Baxter’s Irish Dialysis Production Issue Not Resolved” – Wall Street Journal (1/21/11)

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!