Top Device Companies

St. Jude Issues Court Challenge To Executive’s Move Rival Medtronic

St. Jude Medical presented documents at the beginning of a Minnesota trial against Medtronic over allegations an executive violated his contract in moving to the other firm. Documents filed in St. Jude’s suit against Joseph McCullough, who was head of the company’s U.S. and international division, say he took with him strategic company plans and development details when he left the company, joining Medtronic two months later. St. Jude contends McCullough’s move should be blocked by a noncompete clause in his contact with the company. Since McCullough did not leave St. Jude until May of this year, the firm believes he was bound by contract not to join rival Medtronic for another year after his resignation.(Click here for more – a subscription may be required)

“St. Jude Says Ex-Executive Violated Pact By Joining Medtronic” – 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!

St. Jude, Zimmer Weather Hospital-Equipment Cuts When Others Do Not

St. Jude Medical and Zimmer Holdings appear to be weathering the effort by hospitals to cut costs by paying lower prices for medical devices. Both companies indicated in quarterly reports they were well-positioned to survive the current down economy. Their reports were significant in a market that saw rivals Johnson & Johnson and Stryker already hit by lowered orthopedic sales to hospitals. (Click here for more)

“Zimmer, St. Jude Beat Street; Fight Price Pressure” – Reuters (7/22/10)

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!

Zimmer, Stryker Most Affected By 510(k) Changes, St. Jude, Edwards Less

Zimmer Holdings, Stryker and similar device makers of innovative products not as complex as heart devices have the most to lose later this year when the FDA begins changing its 510(k) approval process. The head of the Center For Devices and Radiological Health attempted in an interview to settle some of the confusion surrounding vows to strengthen regulations. Director Jeffrey Shuren said an agency report on the subject would be issued in a few weeks to clarify the 510(k) updating process, adding some changes would precede the Institute of Medicine’s own report on the issue set for the middle of next year. St. Jude Medical, Edward Lifesciences and other makers of complex heart devices already face tougher reviews of their devices and would be less-affected by 510(k) changes. (Click here for more – a subscription may be required)

“FDA Devices Chief Aims For Clarity Soon On Potential Changes” – Wall Street Journal (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!

Boston Sci, Medtronic, St. Jude May Face Loss Of Favored Sales Targets

Boston Scientific, St. Jude Medical and Medtronic are expected to be affected along with small device makers as hospitals and their medical staffs change the way they interact. Moody’s Investor Service said device makers could face a tougher challenge in attempting to sell their wares directly to physicians. Medtronic and the other major device makers produce stents, defibrillators and other implants considered “physician-preference items,” so sales representatives attempt to deal directly with surgeons. But Moody’s says hospitals and doctors are beginning to create financial alliances that could make that approach harder even for the large device makers. (Click here for more)

“Report: Medical Device Makers May Face Pressure” – Bloomberg (AP) (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!

St. Jude Gets EU Approval For Ablation Device For Heart Treatment

St. Jude Medical won EU approval for its second heart-treatment device in the same week. The latest approval means a CE Mark for marketing the Therapy Cool Flex ablation catheter. The device has yet to gain approval in the United States. Earlier in the same week, St. Jude got a CE Mark for its Ensite contact Technology platform related to heart lesions. (Click here for more)

“St. Jude Medical Wins Another CE Mark For Cardiac Ablation Device” – Mass Device (6/18/10)

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!

St. Jude Settles Justice Kickback Fraud Case For $3.7 Million

St. Jude Medical and the U.S. Justice Department have settled charges of illegal kickbacks to hospitals for $3.7 million. Justice said the firm paid the kickbacks to encourage the hospitals to buy its heart devices, leading to false claims submitted to health-care programs. St. Jude admitted no wrongdoing in the case involving five-year-old allegations, but agreed to the monetary settlement. (Click here for more)

“St. Jude Settles Fraud Case For $3.7 Million” – 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!

St. Jude Gets EU Clearance For Epiducer Lead-Delivery System

St. Jude Medical said European regulators have approved its Epiducer lead-delivery system for neurostimulators. The newly approved version is considered the next generation of systems for delivering electrical shocks from neurostimulators to block transmission of pain signals in cases of chronic back pain. The Epiducer device has not been approved yet for the U.S. market. (Click here for more)

“St. Jude Gets European Approval For Lead Delivery System” – MedCity News (5/27/10)

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!

St. Jude Buys LightLab, Optical Tomography Work For $90 Million

St. Jude Medical says it has acquired Goodman’s LightLab subsidiary for $90 million in cash. The purchase would give St. Jude ownership of an FDA-approved device, the optical coherence tomography that works faster than ultrasound. As such, the device is intended to allow clinicians to see and measure ultrasound elements not visible with previous devices. (Click here for more – a subscription may be required)

“St. Jude to Take Over Goodman Heart Imaging Unit For $90 Million” – Wall Street Journal (5/19/10)

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!

St. Jude, Boston Sci Get Marketing Clearances For Devices

St. Jude Medical says it now has FDA and European approval for its EnSite Derexi module that allows two other heart systems to communicate with each other. St. Jude also has entered a partnership with iRhythm Technologies to develop the smaller firm’s Zio Patch, a cardiac monitor. Boston Scientific also has been cleared to market its Acuity Break-Away lead for defibrillators. (Click here for more)

“New Products” – Minneapolis Star Tribune (5/13/10)

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!

St. Jude Moves Quickly To Implant Defibs After Winning FDA Approval

St. Jude Medical said the FDA has approved the firm’s Unify and Fortify implantable defibrillators that already have been placed in some U.S. patients. The devices have been on the market in Europe and are expected to be sold in Japan by early next year. St. Jude recently was helped with competing against Medtronic and Boston Scientific, the two largest heart-rhythm device makers, when Boston Sci had to halt some of its products over a procedural failure. As part of the announcement, St. Jude said a federal court in Massachusetts has unsealed a whistleblower suit by a former employee concerning marketing practices for such devices. (Click here for more – a subscription may be required)

“St. Jude Implants New Defibrillators In U.S. Patients Upon FDA Approval” – Wall Street Journal (5/12/10)

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!