Happy New Year! Here is the latest batch of news from the medical products community. Please click the link for more.
Regulatory Approvals and Launches
ZOLL Medical Corporation, Chelmsford, MA, a manufacturer of medical devices and related software solutions, announced that its Japanese subsidiary, Asahi Kasei ZOLL Medical (AZM), has received Shonin approval from the Japanese Ministry of Health, Labour, and Welfare to enter the Japanese market with itsX Series®Monitor/Defibrillator.
Reverse Medical Corporation, Irvine, CA, announced FDA clearance for US commercialization of its MVP®-5 Micro Vascular Plug system for peripheral vessel embolization, and the first US clinical case.
Mobius Imaging, LLC, Ayer, MA, has received ISO 13485 Certification for its quality management system, an important milestone toward the commercialization of the Airo® Mobile Computed Tomography System, a one-of-a-kind imaging system.
St. Jude Medical, Inc., St. Paul, MN, a global medical device company, has received European CE Mark approval for its 25 mm Portico™ Transcatheter Aortic Heart Valve Implantation System. The Portico valve is the first transcatheter aortic heart valve that can be completely resheathed, repositioned at the implant site, or retrieved before being released from the delivery system.
W.L. Gore & Associates GORE® VIABAHN® Endoprosthesisto treat stenosis or thrombotic occlusion at the venous anastomosis of synthetic arteriovenous access grafts.
Bunting Magnetics Co., Newton, KS, a producer of precision magnetic products, has made two significant appointments at its headquarters operation. Rod Henricks has been named Director of Sales, and Robert Bunting, Jr., succeeds Henricks as Product Manager-Metal Detection.
Samsung Electronics Co., Ltd., Ridgefield Park, NJ, announced the appointment of Gregory Lee as President of the North America Headquarters in addition to his role as President of Samsung Telecommunications America.
AxoGen, Inc., Alachua, FL, a leader in surgical solutions for peripheral nerve repair, signed an agreement to open a new AxoGen distribution facility in Burleson, TX.
Phillips-Medisize, Hudson, WI, announced the start of production and completion of the 60,000 square feet expansion of its Kontiolahti, Finland site. The Finland site focuses on the industrialization and production of inhalers, insulin pens, transfer devices, and syringes.
Koch Industries, Inc., Wichita, KS, has completed its acquisition of Molex Incorporated, Lisle, IL, a global electronic components company. The acquisition was finalized through the merger of Koch Industries’ wholly owned subsidiary, Koch Connectors, Inc., into Molex.
3D-Micromac AG, Chemnitz, Germany, a leading provider of highly efficient laser micromachining systems, and EOS GmbH, Krailling, Germany, a technology and market leader for design-driven, integrated e-manufacturing solutions in additive manufacturing, are combining their technological know-how in Micro Laser Sintering technology (MLS). The goal of establishing 3D MicroPrint GmbH, Chemnitz, is to advance the development and commercialization of the new MLS technology, and to identify and establish more solutions in the field of micro technology. 3D-Micromac AG and EOS GmbH have been developing Micro Laser Sintering technology together since 2006.
NeuroMetrix, Inc DPNCheck® in China.
New Era Orthopaedics LLC, Hummelstown, PA, an orthopaedic device manufacturer, has entered into an exclusive distribution agreement with medical device manufacturer NeoSteo SAS, Reze, France, that will provide surgeons in the US with the NeoSteo range of osteosynthesis extremity technologies.
Advanced Interconnections Corp., West Warwick, RI, has named Sigma Component Design Ltd., Ontario, Canada, as its new manufacturer’s representative for that Canadian territory.
FANUC has officially merged all of its operations in the Americas into a single company named FANUC America Corporation, Rochester Hills, MI. The new company will have 22 locations. Rick Schneider, previously President of FANUC Robotics America, has been appointed President and CEO of the new company.
SafeStitch Medical, Inc., Research Triangle Park, NC, which recently merged with TransEnterix, Inc., announced the company’s name has been changed to TransEnterix, Inc.
Clear Catheter Systems, Inc., Anaheim, CA, has won the 2013 Innovations in Cardiovascular Interventions Best Start-Up Innovation Award for its medical device, PleuraFlow®, a novel system that evacuates blood and fluid after surgery to speed recovery after heart surgery. The award is the world’s most prestigious for cardiovascular start-ups.
RTEmd, Pittsford, NY, a leading provider of medical device software outsourcing and regulatory support services, achieved its 8th successive year of registrar audits without a non-conformance. With a quality management system certified to ISO 9001:2008 and 13485:2003, by the British Standards Institute, the audit addressed all phases of RTEmd’s quality, software development and management.
Honeywell Sensing and Control, Golden Valley, MN, announced that distributors of electronic components in France picked Honeywell as the industry’s top supplier of electromechanical products in 2013. The award was presented the Syndicat Professionnel de la Distribution en Electronique Industrielle (SPDEI) , which evaluated suppliers on quality, delivery, services, innovation and new products, local presence and support, margin, traceability, and design.
Tektronix, Inc., Beaverton, OR, a leading worldwide provider of test, measurement and monitoring instrumentation, today announced that its AWG70000 Arbitrary Waveform Generator won the Best Test Instrument award from Electronic Engineering and Product World (EEPW) Editors' Choice Awards 2013 – EEPW is the key science and technology magazine in China.
Intertek, Arlington Heights, IL, a leading provider of quality and safety solutions for a wide range of industries around the world, is unveiling a new internship and scholarship program to undergraduate students pursuing studies in science, technology, engineering and math. The Intertek Scholarship Program will award five scholarships up to $10,000, paired with an internship at an Intertek office, to be completed in the summer of 2014.