FDAnews Device Daily Bulletin
Feb. 21, 2005 | Vol. 2 No. 36
IRIS International, a manufacturer and marketer of automated IVD urinalysis systems and medical devices used in hospitals and reference clinical laboratories worldwide, has entered into a supply agreement for its iQ200 Automated Urine Microscopy Analyzer and related products with Broadlane, a provider of procurement management and other business services to the healthcare industry.
Ra Medical Systems has announced that it and PhotoMedex have completed an examination process ordered by the federal court magistrate.
Medical device company DISA Vascular has announced European CE Mark approval and market launch of its ChromoFlex Micro stent system for small coronary vessels, following CE approval of the large-vessel version, the ChromoFlex, in September 2004.
A clinical trial is underway at the Hospital of the University of Pennsylvania to study the safety and effectiveness of an endovascular medical device to treat life-threatening thoracic aortic aneurysms.
Conor Medsystems announced that the company has initiated legal proceedings in the High Court of Justice in the UK to revoke Angiotech Pharmaceutical's patent (No. EP 0 706 376), which relates to stents coated with paclitaxel and a polymeric carrier.
Advanced Neuromodulation Systems said it received a subpoena from the Department of Health and Human Services for documents related to the company's sales and billing practices.
STS duoTEK has been acquired by Buffalo-based Ethox for an undisclosed sum.
Florida Tech and Kunal Mitra, Florida Tech associate professor of mechanical and aerospace engineering, have been assigned a U.S. patent for an X-ray delivery device, which can be used for arterial irradiation following balloon angioplasty.
Axya Medical, a privately held medical device firm, announced that it has completed a $6.8 million private placement of preferred equity led by The Vertical Group of Summit, N.J. The Vertical Group is a venture capital firm that is focused on the fields of medical technology and biotechnology.
Cyberonics announced that the first patient was enrolled in its E20 Phase IV epilepsy study of patients with less chronic and less resistant medically refractory partial onset seizures.
LAM Pharmaceutical, a biomedical company focused on the development and commercialization of novel wound healing and transdermal drug delivery systems, announced that it was achieving excellent results from patient studies currently being conducted in Ecuador, Panama and Costa Rica. Salvador Ficciella, CEO of aQva Pharmaceuticals, LAM's distribution partner in the region, stated, "We are receiving exceptionally
International medical technology company Ventracor announced the immediate appointment of Peter Crosby as Chief Operating Officer (COO) to lead the company's strategic marketing, sales and distribution in Europe and the U.S. Crosby will initially focus on marketing and sales of the VentrAssist left ventricular assist system, as well as clinical trials and regulatory approvals.
MEDTOX Scientific announced that it has filed a 510(k) application with the FDA for clearance to market its Sure-Screen drugs-of-abuse point-of-collection test (POCT) device.
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