FDAnews Device Daily Bulletin
March 24, 2005 | Vol. 2 No. 59
Thoratec has filed for approval to CE Mark its HeartMate II LVAS (left ventricular assist system), the approval of which would allow the commercial launch of the device in Europe.
Advanced Neuromodulation Systems (ANS) has received an FDA investigational device exemption (IDE) approval to implant 160 patients at 12 sites to investigate the safety and efficacy of the ANS Libra Deep Brain Stimulation (DBS) System to treat essential tremor.
Enpath Medical has received CE approval from the EU to begin marketing its steroid epicardial lead in Europe for one of its two contract customers for this product.
Ikonisys has announced the execution of two agreements that grant it license and supply rights to certain DNA probe technology for use with its Celloptics technology platform.
Genetronics Biomedical, a late-stage developer of oncology and other therapies using electroporation to deliver drugs and nucleic acids, announced that its subsidiary, Genetronics, has been granted another patent for a vascular application of its technology, namely U.S. Patent Number 6,865,416, entitled "Electrically Induced Vessel Vasodilation."
Med1Online announced that it has entered into an agreement with Toshiba America Medical Systems to be an exclusive Internet distributor for the company's Nemio ultrasound product line in the U.S.
Nanogen and Pathway Diagnostics announced that they have entered into a nonexclusive, worldwide license agreement under which Nanogen will develop diagnostic products that detect genetic variations associated with responses to antidepressant and antipsychotic therapeutics.
Chindex International, an independent American provider of Western healthcare products distribution and healthcare services in the People's Republic of China, announced that it has entered into definitive agreements with institutional accredited investors with respect to the sale of 1,080,397 shares of its common stock, for an aggregate purchase price of approximately $6.5 million, together with warrants to purchase an additional 378, 137 shares of its common stock.
Pathway Medical Technologies, a medical device developer that ran out of money and shut down in November 2004, has been brought back to life with a $10.1 million investment and a reinvented business model.
EDC Biosystems announced that the U.S. Patent Office has issued U.S. Patent No. 6,863,362 to the company for claims relating to "Acoustically mediated liquid transfer method for generating chemical libraries."
Bio-Matrix Scientific Group announced that it has concluded its search for a chief financial officer (CFO) and has appointed Kevin Elder to the post.
The FDA has approved a clinical trial for a new and much more effective formulation of MethLock, a catheter lock solution developed by Ash Access Technology, a Lafayette, Ind., company focused on vascular access medical solutions to prevent catheter-related bloodstream infections (CRBSI).
Bayer Diagnostics has increased the sensitivity of its automated HBc Total and HIV 1/O/2 assays for use on the ADVIA Centaur Immunoassay System to improve laboratories' detection capability for hepatitis B and human immunodeficiency virus (HIV) infections.
Best Manufacturing, an industrial and medical glove maker, and its parent company, Tillotson, announced the settlement of patent infringement cases pertaining to its patent for thin disposable nitrile gloves (U.S. Patent No. Re. 35, 616).
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