News
Federal Register: Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angi...
September 8, 2010 1:30 pm | by U.S. Food & Drug Administration | CommentsThe guidance was developed as a special control to support the reclassification of PTCA catheters, other than cutting/scoring PTCA catheters, from class III (premarket approval) into class II (special controls).
Federal Register: Cardiovascular Devices; Reclassification of Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters
September 8, 2010 1:30 pm | by U.S. Food & Drug Administration | CommentsThe FDA is reclassifying the device type, standard PTCA catheters, from class III (premarket approval) into class II (special controls). Cutting/scoring PTCA catheters remain in class III and continue to require PMAs.
AngioSculpt "EX" PTCA Scoring Balloon Catheter by AngioScore, Inc.: Recall - Risk of Catheter Separation
September 8, 2010 1:30 pm | by U.S. Food & Drug Administration | CommentsFragments of the catheter may become lodged in coronary arteries, resulting in serious injury or death.
Nursing home co. settles $677M lawsuit for $50M
September 8, 2010 12:45 pm | by The Associated Press | CommentsA California nursing home company has agreed to pay $50 million to settle a lawsuit that resulted in a $677 million jury award in favor of thousands of current and former patients.Orange County-based Skilled Healthcare Group Inc. announced the settlement late Tuesday. The money will go to the...
NVCA launches MedIC life sciences coalition
September 8, 2010 7:32 am | by Mass High Tech: The Journal of New England Technology | CommentsThe National Venture Capital Association, its member venture capital firms and life sciences companies are teaming up to form the Medical Innovation and Competitiveness (MedIC) Coalition, which will advocate for policies and regulations that advance medical innovation in the U.S.
Elekta Among Major Sponsors of Rocks Against Cancer Fundraiser
September 8, 2010 7:32 am | by Bio-Medicine.Org | CommentsATLANTA, Sept. 8 /- Elekta is one of the leading supporters of the Rocks Against Cancer benefit to take place September 16 at the Angel Orensanz Foundation for the Arts in New York City. Proceeds from the event will support EIF cancer programs, including Stand Up to Cancer (SU2C), an...
NEXUS Biosystems Completes Acquisition of REMP Sample Management Business From Tecan Group
September 8, 2010 7:31 am | by Bio-Medicine.Org | CommentsPOWAY, Calif., Sept. 8 /- NEXUS Biosystems, Inc., a leading innovator and worldwide provider of automated sample management systems, today announced the completion of the acquisition of REMP AG of Switzerland, a wholly-owned subsidiary of the Tecan Group. NEXUS announced on July...
Misonix Announces New Distribution Agreement for France
September 8, 2010 6:32 am | by Bio-Medicine.Org | CommentsFARMINGDALE, N.Y., Sept. 8 /- Misonix, Inc. (Nasdaq: MSON ), a developer of state of the art, ultrasonic medical device technology, which worldwide is used for acute health conditions, has entered into a new, three year, exclusive distribution agreement with Cormedica s.a.s. Based...
Updated Phase 2 Data With Flutemetamol Published in Annals of Neurology
September 8, 2010 6:31 am | by Bio-Medicine.Org | CommentsPRINCETON, N.J., Sept. 7 /- GE Healthcare announced today that results from its multicenter phase 2 study of flutemetamol were published in the September issue of Annals of Neurology . Flutemetamol is an investigational positron emission tomography (PET) imaging agent being developed by...
Researchers Explore Use for Head, Neck, Prostate, Breast and Lung Tumors, as Well as More Complex Blood Cancer and Mesothelioma Treatments
September 8, 2010 5:45 am | by The Associated Press | CommentsTomoTherapy Incorporated (NASDAQ: TOMO), maker of advanced radiation therapy solutions for cancer care, today announced that 82 studies examining the use of the TomoTherapy@ treatment system to treat common, complex and rare tumors...
electronica 2010 ? electronics industry demonstrates its future viability
September 8, 2010 5:33 am | by I-Micronews | Commentselectronica will present the future of the electronics industry at the New Munich Trade Fair Center from November 9 to 12, 2010.
Cardiorobotics collects $500K of planned $5M round
September 8, 2010 5:33 am | by Mass High Tech: The Journal of New England Technology | CommentsLess than one year after raising a $5 million funding round, Cardiorobotics Inc. has started another $5 million round with a $500,000 tranche.
Diabetes-focused biotech Rhythm closes $40M Series A round
September 8, 2010 5:32 am | by Mass High Tech: The Journal of New England Technology | CommentsRhythm Pharmaceuticals Inc., a startup focused on obesity and diabetes treatments, had closed a $40 million Series A financing, funded by MPM Capital and Third Rock Ventures, both of Boston, as well as New Enterprise Associates of Maryland.
Streamline Health Document Workflow Solutions Purchased By Tampa, Florida-Based Hospital
September 8, 2010 3:33 am | by Bio-Medicine.Org | CommentsCINCINNATI, Sept. 8 /- Streamline Health Solutions, Inc. (Nasdaq: STRM ) a leading provider of document workflow solutions for hospitals, today announced that a leading Tampa, Florida-based medical institution has purchased three additional workflow licenses to expand the use of...
STAAR Surgical Launches New Visian ICL™ Product Line Extensions at ESCRS
September 8, 2010 3:33 am | by Bio-Medicine.Org | CommentsMONROVIA, Calif., Sept. 8 /- STAAR Surgical Company (Nasdaq: STAA ), the leading worldwide developer, manufacturer and marketer of phakic intraocular lenses, today announced that the Visian Implantable Collamer® Lens (ICL) was featured prominently in more than 40 presentations by...
