FDAnews Device Daily Bulletin
Jan. 17, 2005 | Vol. 2 No. 11
Johnson & Johnson (J&J) says it withdrew 300 of its Cypher stents and found that six of them had less drug coating than required.
W. L. Gore announced that its Gore TAG Thoracic Endoprosthesis received conditional approval for marketing clearance by the Circulatory System Devices Panel of the FDA.
I-Flow has announced that the FDA cleared its 10-inch ON-Q Soaker Catheter for the delivery of local anesthetic to the surgical site to reduce pain following surgery.
St. Jude has completed the acquisition of Endocardial Solutions (ESI) for $11.75 per share in cash consideration which represents an aggregate purchase price of approximately $272 million.
Baptist Cancer Services, a division of Mississippi Baptist Medical Center in Jackson, Miss., acquired the CyberKnife Stereotactic Radiosurgery System, the only such system approved by the FDA for tumor treatment anywhere in the body.
BioSource has announced it was issued U.S. Patent No. 6,818,420, "Methods of Using Fluorescent Energy Transfer (FET) Labeled Oligonucleotides that includes a 3'-5' Exonuclease Resistant Quencher Domain and Compositions for Practicing the Same," by the U.S. Patent and Trademark Office.
Applied Imaging has received 510(k) clearance from the FDA to market its automated application for Chromosome X and Chromosome Y analysis in bone marrow transplant patients.
IntraLase has announced that Health Canada granted a device license amendment for the company's IntraLase FS femtosecond laser, which replaces the hand-held blade historically used to create the corneal flap in LASIK (laser-assisted in-situ keratomileusis).
ViOptix, a Fremont, Calif.-based developer and manufacturer of noninvasive local tissue oxygen measuring devices, has announced that its product, the ODISsey Tissue Oximeter, has received market clearance from the FDA. Market introduction of the ODISsey will take place immediately.
Laboratory Corporation of America (LabCorp) has entered into a new $350 million senior credit facility with Credit Suisse First Boston and UBS Securities acting as co-lead arrangers, and a group of seven other financial institutions.
Master Bond's newly developed flexible two component epoxy resin system EP21LV (3/5) has obtained full USP Class VI Certification for the assembly of disposable and reusable medical devices.
Medical, an emerging medical laser company based in Carlsbad, Calif., was dragged through lengthy legal action by PhotoMedex, a publicly traded company based in Pennsylvania with manufacturing facilities in Carlsbad.
Molecular Diagnostics has announced it successfully completed the payments necessary to settle their prior Internal Revenue Service (IRS) federal payroll tax liability.
Sogo Clinical Pharmacology announced it agreed with Kodak Health Imaging Division to form a business alliance in the field of diagnostic imaging.
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