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Fdanewsdevicedailybulletin

March 25, 2005

Vol. 2 No. 60

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FDA Approves GORE TAG to Treat Descending Thoracic Aneurysms

The FDA has approved the GORE TAG Endoprosthesis System, an endovascular grafting system that is intended to prevent ruptures of descending thoracic aneurysms by making a new path for blood flow.

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Medtronic Introduces Its Attain Select Catheter Set

Medtronic has announced the recent introduction of the Medtronic Attain Select 6238 TEL Guide Catheter Set that aids in the safe and effective implantation of device leads in the veins that serve the left side of the heart for the treatment of heart failure.

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Conor Receives Conditional IDE to Begin COSTAR II Trial

The FDA has given Conor Medsystems conditional approval of an investigational device exemption to begin its COSTAR II pivotal clinical trial to support U.S. regulatory approval of the company's CoStar stent.

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First Patient Enrolled in U.S. DES Trial to Treat PAD

The first patient was treated at Stanford University Medical Center in a clinical trial evaluating a drug-coated stent from Cook for peripheral arterial disease (PAD), a serious medical condition that affects more than 10 million Americans each year.

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MIVT Receives Grant to Expedite Development of HAp Stent Coating

MIV Therapeutics (MIVT) announced that its wholly owned subsidiary, MIVI Technologies -- which is involved in the research and development of multilayer coating technologies with drug eluting capability for cardiovascular stents and other implantable devices -- has received a government grant for the research program titled, "Development of Novel Drug Eluting Composite Coatings for Cardiovascular Stents."

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STERIS Acquires FH Surgical SAS

STERIS announced that it has completed the acquisition of FH Surgical SAS, a privately held manufacturer of surgical tables with approximately 40 employees and manufacturing facilities in Orleans, France.

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HemoSense Signs Agreements With FDI, STAT and Whitmire Medical

HemoSense announced the signing of distribution agreements with FDI Medical, STAT Technologies and Whitmire Medical to market, sell and distribute HemoSense's INRatio product line to professional healthcare providers in the U.S.

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Masimo Wins Antitrust Lawsuit Against Tyco

Masimo, the inventor of read--through motion and low perfusion pulse oximetry, announced that a federal court jury in Los Angeles has found that Tyco Healthcare violated the antitrust laws through anticompetitive business practices specifically related to the sale of its Nellcor pulse oximetry products.

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Cygnus Completes $10 Million Asset Sale to Animas

Cygnus announced that it completed the sale of substantially all of its assets (other than cash and cash equivalents, accounts receivable and its rights in the arbitration matter with Ortho-McNeil Pharmaceutical) to Animas and Animas Technologies for $10 million in cash.

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Siemens Receives 510(k) Clearance for 550 TxT Treatment Table

Siemens Medical Solutions announced that its 550 TxT Treatment Table has received 510(k) clearance from the FDA and is now commercially available in the U.S.

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Atlantis Announces Compatibility With Straumann RN Implants

Atlantis Components announced that the Atlantis Abutment is compatible with the Straumann RN Implant.

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Nymox Makes Progress in Global Marketing of Alzheimer Test

Nymox Pharmaceutical continues to make progress in the global marketing strategy for the company's urine testing technology for Alzheimer's disease.

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Elekta Neuromag Receives Regulatory Approval in Canada

Health Canada -- the Canadian federal health department -- announced that Elekta Neuromag is cleared for sale within the Canadian healthcare system.

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