FDAnews Device Daily Bulletin
Jan. 4, 2005 | Vol. 2 No. 2
Lumenis and OpusDent, Lumenis' dental laser division, have announced the FDA clearance of the OpusDuo Er:YAG laser system for contact bone removal during oral surgical and periodontal procedures.
Cardima, developer of the INTELLITEMP and REVELATION series of cardiac interventional systems for the treatment of atrial fibrillation, has received written notice from Nasdaq that the company has regained compliance with Nasdaq Marketplace Rule 4310(c)(2)(B).
Roche Diagnostics has signed a new dual-source, three-year contract with Chicago-based Consorta to provide hospital glucose meters, test strips, lancets and ancillary connectivity solutions.
Affymetrix has granted Veridex, a Johnson & Johnson company, long-term and comprehensive access to its GeneChip technology to create and market in-vitro diagnostics for cancer.
Microvision has entered into a multiphase, exclusive license and product development agreement with Ethicon Endo-Surgery, a subsidiary of Johnson & Johnson, whereby Microvision and Ethicon Endo-Surgery will collaborate to integrate Microvision's proprietary technology into certain medical products.
Bio-Rad, a multinational manufacturer and distributor of life science research products and clinical diagnostics, has received marketing clearance from the FDA for its BioPlex 2200 system, a new immunoassay platform that employs multiplexing technology to analyze for multiple disease states from single patient samples.
NIR Diagnostics, a developer of near-infrared instruments, has completed a tax-assisted financing for gross cash proceeds of $901,350, received from GTTS as part of the company's participation in the Biotechnology Investment Fund Program, managed by IATRA Management Services.
CoreValve has received approval from the German government - Bezirksregierung Koln, state of Nordrhein-Westfalen, Cologne -- to immediately commence a clinical trial of its proprietary ReValving System to nonsurgically replace diseased aortic heart valves in 10 patients who are contraindicated for open-heart surgery.
Micro Therapeutics (MTI) has announced the consolidation of its global manufacturing operations into a single manufacturing location at its headquarters in Irvine, Calif., and the closure of its facility in Bochum, Germany, effective Dec. 30, 2004.
Oklahoma City, Okla.-based American Health Partners Oklahoma was chosen by ThyroTec, a New Jersey-based medical products development company, to launch a presence in the market, establish brand equity, finalize product packaging and develop and implement all sales and distribution functions for ThyroTest, a new FDA approved, CLIA waived rapid hypothyroid diagnostic screening device.
Antares Pharma has announced that initial sales of recombinant human insulin along with Antares Pharma's needle-free injection device, the Medi-Jector VISION, have begun in India under the trade name Recojet.
Scientific Industries has announced the expansion of the range of its MagStir Genie product line with the introduction of the MultiMagStir Genie multiple-position digital programmable magnetic stirrer.
Sonic Innovations -- a designer, developer, manufacturer and marketer of advanced digital hearing aids -- announced that, on Dec. 23, 2004, it accelerated the exercisability of stock options previously awarded to employees, officers and directors with exercise prices greater than the closing price of its common stock as of Dec. 23, 2004 of $4.18 per share.
Blood pressure monitor maker MedWave postponed the filing of its annual report and its investor conference call.
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