Here is the latest batch of news from the medical products community. Please click the link for more.
Regulatory Approvals and Launches
The FDA has allowed marketing of the DEKA Arm System from DEKA Integrated Solutions, Manchester, NH, the first prosthetic arm that can perform multiple, simultaneous powered movements controlled by electrical signals from electromyogram electrodes detecting the contraction of muscles close to where the prosthesis is attached.
TERUMO, Somerset, NJ, a global medical device company, announced the US launch of its new GLIDEWAY™ Ureteral Access Sheath used in minimally invasive urologic procedures.
SynCardia Systems, Inc., Tucson AZ, has received the CE Mark for the SynCardia temporary Total Artificial Heart with SynHall™ valves, providing the company with control over the last key component required for heart manufacturing.
Matrix Surgical USA, Atlanta, GA, a leader in the development, manufacturing, and commercialization of craniomaxillofacial implants, has received a 510(k) clearance to market its High-Density Polyethylene Customized Surgical Implants for use in craniofacial reconstruction and augmentation.
Gauss Surgical, Los Altos, CA, announced that its Triton Fluid Management System™, the world’s first and only mobile platform for real-time estimation of surgical blood loss on surgical sponges, has received FDA approval.
Cothera LLC, Plano, TX, a global medical device manufacturer, has received the CE Mark for its portable VPULSE System, which combines intermittent pneumatic compression for deep vein thrombosis prevention, dynamic compression therapy, and cold therapy into a post-surgical rehabilitation device.
Vision-Sciences, Inc., Orangeburg, NY, a leading provider of unique flexible endoscopic products utilizing its proprietary sterile disposable EndoSheath® technology, announced the launch of its next generation video bronchoscope and EndoSheath technology.
Neuros Medical, Inc., Cleveland, OH, a neuromodulation device company, announced the issuance of a new US Patent for its High Frequency Electrical Nerve Block technology.
The FDA has approved the first wireless implantable hemodynamic monitoring system for patients with heart failure, theChampion HFMonitoring System fromCardioMEMS, Atlanta, GA, which measures mean pulmonary-artery pressures and heart rate.
Coatings2Go, Carlisle, MA, a global leader in the manufacturing of water-based medical coatings, has received ISO 13485 certification for worldwide distribution. ISO 13485 sets out the criteria for quality management systems and provides the necessary framework for improving company efficiency, minimizing risk, and maximizing opportunity.
Leadership News
Esaote North America, Inc., Indianapolis, IN, a leading provider of multi-disciplinary ultrasound and musculoskeletal MRI systems in the US, announced that Larry Dentice has been named President and General Manager. In this role, Dentice is responsible for driving the growth of Esaote’s medical imaging business in the United States and will oversee all aspects of U.S. and Canada business operations.
Invacare Corporation, Elyria, OH, announced that Michael J. Merriman has been elected to its Board of Directors.
Nordson ASYMTEK, a Nordson company, Carlsbad, CA, a leader in dispensing, jetting, and coating equipment and technologies, announced the appointment of Chris Marion as Director of Marketing and Applications Technology.
J-Pac Medical, Somersworth, NH, a provider of market-ready solutions customized for medical device and diagnostics customers, has appointed William (Billy) Morrison as Vice President of Manufacturing Operations andBlake Perkins as Director of Diagnostic Business Development.
Bunting® Magnetics Co., Newton, KS, a producer of precision magnetic products, has named Jeffrey “Scott” Smith as Supply Chain Manager.
SpineGuard Inc., San Francisco, CA, which is focused on improving spine surgery safety with its line of bone-monitoring devices, announced that Kris Kumar has joined the company as US Marketing Director.
Expansions/Moves
MicroCare Corp., New Britain, CT, a leading global manufacturer of precision cleaning, coating, and lubrication products, announced plans to open a distribution center in Singapore to serve its rapidly-expanding customer base in the Pacific Rim. This new facility will support end-users located throughout the Association of Southeast Asian Nations marketplace as well as the greater China marketplace. Managing the new division will be Jerald Chan, who was recently hired as regional sales manager.
Medical Murray, North Barrington, IL, an ISO 13485 certified and FDA registered medical device development and contract manufacturing company, has opened its newest design and development facility, located in San Carlos, CA. The new facility will focus on designing, building, and testing medical devices including complex catheters and implants.
CSA Group, Toronto, Canada, a leading global provider of standards development, testing, and certification services, has opened a new testing laboratory in Frankfurt am Main, Germany on May 15. The new laboratory will specialize in testing and certification services for medical devices such as microscopes, sterilizers, and electrical measuring and laboratory devices.
Mirrorcle Technologies, Inc., Richmond, CA, a leading manufacturer of gimbal-less microelectromechanical system mirrors, has opened an all-new company headquarters. The 7,000 square foot facility houses operations, R&D, and manufacturing departments.
Mergers/Acquisitions/Collaborations/Licensing
Bayer AG, Leverkusen, Germany, agreed to sell its Interventional device business to Boston Scientific, Natick, MA, to expand its portfolio of solutions to treat peripheral vascular disease and include systems used in cardiology, radiology and peripheral vascular procedures.
Lumetrics®, Rochester, NY, announced that Skiba Inc., Evergreen, CO, will start selling and supporting Lumetrics’ OptiGauge® thickness measurement system and other measurement solutions in the mountain states region.
HORIBA Medical, Montpelier, France, and Medica Corporation, Bedford, MA, have entered into a non-exclusive agreement for the worldwide distribution of the EasyCell assistant digital hematology cell imaging system.
Miscellaneous
Miyachi America Corporation, Monrovia, CA, a leading manufacturer of welding, marking, cutting, and micro machining equipment and systems, announces that its parent company, Miyachi Corporation, has changed its name to Amada Miyachi Co., Ltd. The company has been part of the Amada Group since March 2013, and the name change increases the parent company’s recognition and brand awareness while maintaining the association with Miyachi’s long and successful history as a provider of advanced technology.
Agilent Technologies Inc., Santa Clara, CA, has provided the Massachusetts Institute of Technology with industry-leading test instrumentation to equip instructional laboratories at the school's Electrical Engineering and Computer Science department.
Versicor, Royal Oak, MI, an electronics, controls, and software development solutions company, is providing a total of $250,000 worth of electronics, controls, and software development services to start-up and seasoned businesses in the medical device, clean tech, and transportation industries through its new contest “Ideas to Action”. For more information, visit http://goversicor.com/ideas-2-action .
KOA Speer Electronics, Bradford, PA, a leading supplier of passive electronic components, announced they have received the 2013 Platinum, Diamond and Best Quality Awards for Supplier Excellence from TTI, Fort Worth, TX, a specialty distributor of passive, interconnect, electromechanical and discrete components.
Henkel Corporation, Rocky Hill, CT, was recently honored as the recipient of the BD (Becton, Dickinson and Company) 2013 Sustainability Award, which recognized Henkel both for the work it has done with BD to reduce costs and streamline manufacturing production, and for internal efforts within Henkel to demonstrate corporate social responsibility.
Phillips-Medisize Corporation, Hudson, WI, a leading global outsource provider of design and manufacturing services, was presented with the President’s “E” Award for Exports at a ceremony in Washington, DC on May 28. The “E” Awards are the highest recognition any US entity may receive for making a significant contribution to the expansion of US exports.
