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Pyng Medical Corp. Receives US FDA 510(k) Clearance For FASTx™
9/8/2010
Pyng Medical Corp. (TSX VENTURE:PYT) announces today that it has received 510(k) clearance from the US FDA to market the FASTx™ Sternal Intraosseous Device. The company will now begin ramping up production to meet the anticipated demand for this next generation IO product
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Unilife Corporation Secures FDA 510k Clearance For The Unitract™ 1mL Tuberculin Syringe
9/8/2010
Unilife Corporation ("Unilife" or "Company") (Nasdaq: UNIS, ASX: UNS), today announced that its Unitract™ Tuberculin (TB) Syringe has received 510(k) market clearance from the U.S. Food and Drug Administration (FDA).
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BARRX Medical Signs Distribution Agreement With Medico’s Hirata For Exclusive Distribution Of The HALO Radiofrequency Ablation System In Japan
9/8/2010
BARRX Medical, Inc., a world leader in endoscopic treatment solutions for treating precancerous lesions of the esophagus as well as other chronic gastrointestinal diseases, announced today that the company has signed an exclusive agreement with Medico's Hirata for distribution of the HALO Radiofrequency Ablation System in Japan
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Medtronic Gains CE Mark For Enhanced CoreValve Delivery Catheter System With AccuTrak Stability Layer
9/7/2010
Medtronic, Inc. today announced CE (Conformité Européenne) Mark approval and the first global use and launch of the Medtronic CoreValve delivery system with AccuTrak Stability Layer for transcatheter aortic valve implantation (TAVI). AccuTrak's proprietary technology allows physicians to achieve enhanced control and accuracy in the deployment of the CoreValve device
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Teleflex Introduces The PICC WAND
9/7/2010
Teleflex has partnered with Access Scientific Incorporated, San Diego, California to become the U.S. distributor of The PICC WAND Safety Introducer with ARROW peelable sheath. This new, all- in-one vascular access device provides clinicians a faster, safer, simpler way to insert a peel away sheath for PICC or Midline catheter placements
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AtheroMed, Inc. Announces Launch Of EASE Clinical Trial To Evaluate Peripheral Arterial Disease Treatment
9/7/2010
AtheroMed, Inc. announced today the start of enrollment in the EASE study to evaluate the safety and effectiveness of the Phoenix Atherectomy catheter, a minimally invasive device for the treatment of peripheral arterial disease (PAD) in the legs
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K2M Receives 510(k) Clearance For Its CHESAPEAKE Anterior-Lumbar Stabilization System
9/7/2010
K2M, Inc., a spinal device company developing innovative solutions for the treatment of complex spinal pathologies, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its new CHESAPEAKE Anterior-Lumbar Stabilization System, a unique interbody device designed for stabilization of the spine through an anterior approach
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Document Security Systems, Inc. Signs Licensing Agreement With Pharmaceutical Label Manufacturer
9/2/2010
Document Security Systems, Inc. (NYSE Amex: DMC), announced today that it has signed a licensing agreement with Wisconsin-based ATL, Inc., a secure product label manufacturer.
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Saint Barnabas Medical Center Implements ZOLL AutoPulse
9/1/2010
ZOLL Medical Corporation, a manufacturer of medical devices and related software solutions, announced today that Saint Barnabas Medical Center, one of the largest non-profit, non-sectarian hospitals in New Jersey, has installed the AutoPulse Non-Invasive Cardiac Support Pump for resuscitative capabilities in the hospital's emergency department
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IntraOp Medical Corporation Announces Purchase Of Two Next Generation Mobetrons By UCSF
9/1/2010
IntraOp Medical Corporation today announced that the University of California, San Francisco (UCSF) Medical Center has purchased two next generation Mobetrons for Intra-Operative Electron Radiation Therapy (IOERT)
