FDAnews Device Daily Bulletin
Jan. 11, 2005 | Vol. 2 No. 7
Wright Medical announced a reimbursement "J" code has been assigned for the company's GRAFTJACKET Ulcer Repair Matrix, a treatment for chronic wounds often associated with diabetes.
The first fenestrated endograft for the treatment of abdominal aortic aneurysm (AAA) in Cook's pilot study of advanced endovascular treatments for this life-threatening condition has been implanted.
Devax announced that enrollment has been completed in the AXXESS PLUS clinical study for the company's AXXESS Drug Eluting Bifurcation Stent System -- a multi-component stent delivery system comprising self-expanding Nitinol stents specifically engineered for the treatment of coronary and vascular bifurcation lesions.
RetinaPharma announced it received 510(k) FDA clearance to market its TonoPach device that enables more accurate intra-ocular pressure (IOP) determinations in patients.
Chindex International announced an exclusive, multiyear distribution agreement for the People's Republic of China with Intuitive Surgical, the innovator and market leader in surgical robotics.
BioCardia and Symphony Medical announced a mutually exclusive agreement for development and commercialization of a combination product that combines Symphony Medical's biotherapeutic technology and BioCardia device delivery technology for the treatment of cardiac conduction disorders.
Conor Medsystems announced that the underwriters of the company's recent initial public offering of its common stock have exercised in full their over-allotment option to purchase an additional 900,000 shares of the company's common stock at a price of $13 per share, before deducting underwriting discounts and commissions.
TransPharma Medical announced it signed a long-term development, distribution and supply agreement with Teva Pharmaceutical Industries.
Pro-Dex announced it received a follow-on order from Walter Lorenz Surgical, a wholly-owned subsidiary of Biomet.
A new computer-aided detection (CAD) system can help radiologists detect polyps in colons that contain contrast-enhanced fluid, says a new study that appears in the January issue of the American Journal of Roentgenology.
Infectech announced it filed with the FDA to begin the production, marketing and commercializing of its biophasic system devices intended for medical purposes to cultivate and identify certain pathogenic microorganisms.
NEW NONINVASIVE TREATMENT FOR UTERINE FIBROIDS REDUCES NEED FOR THE OVER 200,000 HYSTERECTOMIES PERFORMED EACH YEAR IN THE U.S.
Beverly Tower Imaging Center announced the offering of a revolutionary and completely noninvasive procedure to treat symptomatic uterine fibroids.
Ten patients with complete motor and sensory spinal cord injury were implanted with an experimental device designed to regenerate nerve fibers, promoting some degree of functional recovery.
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