Athersys-Pfizer IBD phase 2 trial to wrap up by end of the year

Stem cell therapeutics developer Athersys’ (NASDAQ:ATHX) phase 2 clinical study investigating the treatment of inflammatory bowel disease with partner Pfizer (NYSE:PFE) is expected to complete patient enrollment by the end of 2012.Top-line results of the inflammatory bowel disease trial are likely to be available in early 2013, Athersys CEO Gil Van Bokkelen said in a [...]

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STERIS sees new fiscal year as ‘turning point’ as it completes System 1 transition

Medical device company STERIS (NYSE:STE) is viewing its recently started fiscal 2013 as a “turning point” for the company, as it moves beyond a lengthy and costly transition from its flagship sterilization system.Mentor, Ohio-based STERIS experienced several challenges to its bottom line last year, including costs associated with moving customers to its System 1E, a [...]

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Meridian Bioscience in midst of clinical trials for two molecular tests

Meridian Bioscience‘s (NASDAQ:VIVO) has two molecular diagnostic tests in clinical trials, with another test expected to begin trials later in the year.Currently in trials are tests built on the company’s illumigene molecular diagnostic testing platform for Mycoplasma pneumonia, an infection of the lungs, and group A streptococcus, a type of bacteria often found in the [...]

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Regulatory, compliance issues continue to weigh down Invacare

Regulatory and compliance issues have diverted resources at home health products supplier Invacare (NYSE:IVC) away from “critical priorities” in the company’s business and have resulted in delays of new product introductions and slowed progress on a key globalization initiative.Those issues stem from negotiations with the U.S. Food and Drug Administration over a possible shutdown of [...]

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Novel obesity treatment firm EnteroMedics records revenue for the first time

Novel obesity treatment company EnteroMedics(NASDAQ:ETRM)that has survived a close brush with disaster recorded revenue for the first time since it was incorporated nearly eight years ago.On Tuesday, the company reported revenue of about $123,000 in the first quarter of the year that were garnered from the sale of its implantable neuromodulation system — Maestro RC [...]

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STERIS gets 510(k) clearance on software modification to liquid sterilization system

STERIS (NYSE:STE) has received 510(k) clearance from the U.S. Food and Drug Administration for software modifications to its System 1E liquid chemical sterilization system.The modifications are related to system aborts that were caused primarily by water-temperature issues, STERIS spokesman Steve Norton said.The System 1E is a liquid chemical sterilizing system used by hospitals, surgical centers [...]

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AtriCure: Training surgeons for AF procedure takes on big importance

Late last year, an ablation system from cardiology device maker AtriCure (NASDAQ:ATRC) became the first device to secure U.S. Food and Drug Administration clearance for the surgical treatment of atrial fibrillation.Now, the Cincinnati-area company’s attention will turn to training surgeons to perform atrial fibrillation procedures using its device, the Synergy Ablation System.CEO David Drachman said [...]

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Nonprofit Mayo’s operating income jumps on higher volumes of surgery

The Mayo Clinic announced Thursday that higher volumes of surgery and higher numbers of complex medical cases helped operating income jump 18.4 percent to $610.2 million last year compared with 2010.Revenue also climbed to $8.5 billion in 2011 from $7.9 billion in 2010.In 2011, Mayo Clinic cared for 1.11 million patients across its three locations [...]

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STERIS System 1E sales continue to lag earlier projections

Sterilization products maker STERIS (NYSE:STE) reported that shipments of its System 1E sterilizer continue to fall below the company’s earlier projections.The Mentor, Ohio-based company now projects that it’ll ship 4,000 System 1E units in its fiscal 2012, which is scheduled to end on March 31, company executives said Tuesday in a conference call to discuss [...]

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Invacare still negotiating with FDA over possible plant shutdown

Home health products supplier Invacare (NYSE:IVC) is still enmeshed in negotiations with the U.S. Food and Drug Administration over a possible shutdown of some wheelchair production at an Elyria, Ohio plant.In December, Invacare announced that the FDA had asked it to enter into a legal agreement that would require the company to suspend “certain” wheelchair [...]

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