FDAnews Device Daily Bulletin
Jan. 18, 2005 | Vol. 2 No. 12
Edwards Lifesciences, a maker of heart valve technologies, has entered into an agreement with St. Jude Medical resolving patent infringement litigation initiated by Edwards in June 2000 related to certain Edwards patents in the areas of heart valve repair and replacement.
A lawsuit between an Israeli stent maker and a U.S. biotech giant is slated to go to trial June 20, with as much as $1.5 billion at stake.
Laser and light-based medical devices company Lumenis has announced an agreement with Eclipse Medical, its distributor for aesthetic products in four states in the South Central U.S.
Sysmex announced the development of a new technology based on a cell cycle profiling for diagnosis of the risk of recurrence in patients with early-stage cancer.
Corgenix Medical, due to the lack of progress toward the completion of the $6 million merger-related financing and the expiration of key dates within the agreement and plan of merger, decided to terminate the planned merger with Genesis Bioventures.
NDO Surgical closed a $15 million round of venture capital funding, the company announced.
Enpath Medical has reported that the FDA requested more clinical data regarding the company's Myopore Rx steroid lead before the agency will consider the company's request for marketing clearance.
CryoCath, a maker of cryotherapy products to treat cardiovascular disease, has announced that Vivek Reddy of the Massachusetts General Hospital presented additional data on a human feasibility study using the company's proprietary Arctic Circler Balloon catheter to treat atrial fibrillation (AF).
Accuray has completed the purchase of certain assets of the High Energy Systems Division of American Science and Engineering.
CABG Medical 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 825,000 shares of the company's common stock at a price of $5.50 per share, before deducting underwriting discounts and commissions.
Voice Diary has announced it is reviewing its strategic plan and is considering alternatives to expand its core technology and add additional lines of products through strategic acquisitions or mergers.
Terumo has announced payment of damages, in the amount of 590,869 euros, by Biosphere Medical, in accordance with the judgment rendered in favor of Terumo Europe Nov. 18, 2004.
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