FDAnews Device Daily Bulletin
Feb. 25, 2005 | Vol. 2 No. 40
Boston Scientific has announced the start of enrollment in the world's largest drug-eluting stent registry: the Taxus OLYMPIC registry.
Cardiovascular Systems announced it received recommendation for ISO 13485:2003 registration of its quality management system.
R2 Technology has received FDA approval to expand the use of its ImageChecker D product for CAD processing of images acquired with the Siemens Medical Solutions MAMMOMAT NovationDR and viewed on Siemens' MammoReportPlus softcopy reporting workstation.
Raymedica, a manufacturer of nonfusion spinal implants for the treatment of back pain, has announced that Medtronic will return the European and Indian distribution rights of the PDN-SOLO Prosthetic Disc Nucleus to Raymedica.
Medical devicemaker Stryker reported that it bought privately held eTrauma.com for $50 million in cash to incorporate the digital imaging software company with its orthopedics business.
Taking advantage of a spate of high-value acquisitions of spinal implant developers and recent U.S. government approval of the first artificial spinal disk, AxioMed Spine raised $18 million in a second round of venture capital led by Thomas, McNerney & Partners.
Current Technology, developer of ETG (ElectroTrichoGenesis), a patented electrotherapeutic device that provides a clinically proven medical treatment for hair loss, announced that it has received the CE Medical Mark for its ETG Mark I device.
Argonaut Technologies has entered into a definitive agreement under which Argonaut Technologies will sell stock and certain assets of its consumables and flash chromatography business to Biotage AB of Uppsala, Sweden.
CryoLife, a biomaterials and biosurgical device company, announced that a patient received the first Cryopreserved osteoarticular (OA) allograft transplant for resurfacing articular cartilage in the knee.
Biolase Technology, a medical technology company that develops, manufactures and markets lasers and related products focused on technologies for improved applications and procedures in dentistry and related specialties, announced the signing of a fully paid license agreement related to patents owned or licensed by SurgiLight in the field of Presbyopia, which is a phenomenon of natural aging that results in the loss of near-reading ability over the age of 40 years old.
Encore Medical shelled out $14.5 million to purchase the assets of competitor Osteoimplant Technology of Baltimore, which makes spinal, hip and knee implants.
Zimmer Holdings announced that the first electromagnetic Computer-Assisted Solutions knee replacement procedure was successfully performed Feb. 14 at The Methodist Hospital in Houston, Texas. David Lionberger, an orthopedic surgeon at Methodist, performed three successful navigation assisted procedures using the Zimmer Minimally Invasive Solutions (MIS) Quad-Sparing Total Knee Replacement Procedure and Medtronic Navigation's proprietary StealthStation with the AxiEM electromagnetic computer assisted system.
Scandius BioMedical, a Littleton, Mass.-based medical device company focusing on minimally invasive orthopedic implants and surgical instruments, has raised $8 million through the private sale of Series C preferred stock.
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