Here is the latest batch of news from the medical products community. Please click the link for more.
Regulatory Approval and Launches
ArjoHuntleigh, Addison, IL, has launched the Dopplex® Ability, an Ankle Brachial Index (ABI) screening device that reduces the time it takes to perform ABI measurements by up to 75% vs. traditional methods.
Pulsar Vascular, San Jose, CA, has received the CE Mark for its lead product, the PulseRider®, a unique implant used to bridge the neck of cerebral aneurysms previously not amenable to endovascular therapy.
Samsung Electronics America, Inc., a subsidiary of Samsung Electronics Co. Ltd, announced the launch of its first tablet-based ultrasound system: the Samsung UGEO PT60A. The system received 510(k) FDA clearance in August and completed its domestic product review in September.
Jacoti bvba, Brussels, Belgium, received CE medical device approval for its software hearing aid Jacoti ListenApp® and approval for its Quality Management System. This is the first of its kind: a standalone software-based hearing aid.
Medtronic, Minneapolis, MN, announced that its Advance Aspiration catheter, designed to remove thrombi from coronary arteries during angiographic procedures, has won FDA approval in the US.
Cardiovascular Systems, Inc., St. Paul, MN, has received PMA approval from the FDA to market its Diamondback 360® Coronary Orbital Atherectomy System to treat severely calcified coronary arteries.
St. Jude Medical, Inc., St. Paul, MN, a global medical device company, announced FDA approval and the launch of its ILUMIEN™ OPTIS™ PCI Optimization™ System, a new technology designed to provide physicians with a comprehensive disease assessment tool for treating patients with coronary artery disease.
OSTAR Healthcare Technology, Vancouver, WA, announced the North American launch of its revolutionary 3SI (3 simultaneous interpretations) Advanced Diagnostic Blood Pressure Algorithm.
Leadership News
Freedom Innovations LLC, Irvine, CA, a manufacturer of advanced technology prosthetic devices, announced that Joe W. Martin has been appointed to the newly created position of President & Chief Operating Officer, Maynard Carkhuff, will assume the role of Chairman and CEO, and Rob Cripe, was promoted to Executive Vice President of North American Commercial Operations and Global Marketing.
Harvard Bioscience, Inc., Holliston, MA, a global developer, manufacturer, and marketer of a broad range of tools to advance life science research, has hired Yoav Sibony as Vice President of Global Sales.
ICU Medical, Inc., San Clemente, CA, announced that due to health reasons Dr. George Lopez will step down as President and Chief Executive Officer but will continue in his role as Chairman of the Board and will remain an employee in the R&D Department. Steven Riggs, current Vice President of Operations, has been appointed as Acting Chief Executive Officer.
Resonetics, Nashua, NH, a leading supplier of polymer laser micromachining services and systems for the life sciences industry, announced that David Fogaren has been named Vice President, Operations.
Pfeiffer Vacuum, Nashua, NH, one of the world's leading providers of vacuum solutions, announced the appointment of Robert Campbell as President of Pfeiffer Vacuum Inc.
Sapiens Steering Brain Stimulation, Eindhoven, the Netherlands, a medical device company pioneering brain stimulation products incorporating steerable stimulation, has appointed Jan C. M. Keltjens as the new President and CEO of the company.
Dow Corning , Midland, MI, a global leader in silicones, silicon-based technology and innovation, announced the appointment of Tang Yong Ang “TY” to vice president of Dow Corning’s Compound Semiconductor Solutions.
America Semiconductor, LLC, Union, NJ, a manufacturer of state-of-the-industry high-power semiconductors, named David Geltman to the newly created position of vice president of sales and marketing.
IlluminOss Medical, East Providence, RI, pioneering the development of minimally invasive, customized orthopedic implants to stabilize and treat bone fractures, announced the appointment of Martin Aschenbrener as Vice President of Finance.
Orchid, Holt, MI, a medical device contract design and manufacturing company, announced the promotions of two key individuals: Joe Zuzula was named Vice President of Sales and Marketing, and Bill Ditty was named Vice President of Quality and Regulatory Compliance.
Laird, London, UK, a global technology company, announced the appointment of Rick Morse as Senior Vice President and General Manager of its Wireless Automation and Control Solutions Business, a unit of Laird’s Wireless Systems Division.
Expansions/Moves
Moog Animatics, Santa Clara, CA, is moving its main office and production to an existing Moog location in Milpitas, CA, effective November 1, 2013.
Intelligrated, Mason, OH, an automated material handling solutions provider, announces the relocation of its software subsidiary company, Knighted to a new, larger facility in Elmsford, NY. The 26,600-square-foot space is nearly four times larger than Knighted's former headquarters.
B.Braun Medical Inc., Bethlehem, PA, has purchased undeveloped 21.5 acres of land from Lehigh University in Bethlehem for a new state-of-the-art headquarters campus.
Mergers/Acquisitions/Collaborations
America Semiconductor, LLC, Union, NJ, a manufacturer of state-of-the-industry high-power semiconductors, signed a distribution agreement with Singapore-based AddCom Solution Pte Ltd. that authorizes AddCom to supply, support, and promote America Semiconductor's full lines of high-power and discrete semiconductor products throughout Asia.
Wright Medical Technology, Inc., Arlington, TN, has entered into a definitive agreement to acquire Biotech International (Biotech), Salon-de-Provence, France, a leading, privately held orthopaedic extremities company.
ADLINK Technology, Inc., San Jose, CA, a provider of embedded computing products application ready intelligent platforms for industrial automation, communications, medical, defense, and transportation industries, announced an agreement with Elma Electronic Inc., Fremont, CA, for the sale of ADLINK products in integrated embedded computing systems throughout North America.
Isola Group S.à.r.l., Chandler, AZ, a market leader in copper-clad laminates and dielectric prepreg materials used to fabricate advanced multilayer printed circuit boards, announced that its German subsidiary, Isola GmbH, has entered into a distribution agreement with Holders Technology plc, Galashiels, Scotland, to sell selected materials in the UK.
TechDevice Corporation, Watertown, MA, has acquired AdvancedCath Technologies, San Jose, CA, which produces highly engineered advanced catheter systems.
Richard Wolf Medical Instruments Corp., Vernon Hills, IL, a leading manufacturer of medical endoscopes, has entered an agreement to become the exclusive distributor of the Thermedx Fluid Management System, which pressurizes and delivers irrigation fluid to distend and irrigate the surgical site during certain gynecological and urological surgical procedures. Thermedx, LLC, Cleveland, OH, is an emerging leader in the design and manufacture of fluid management systems.
Miscellaneous
Averna, Montreal, Canada, an industry-leading developer of test solutions and services for communications and electronics device-makers, has received a Broadband Technology Report Diamond Technology Review ranking of 4 “Diamonds” for its DOCSIS Channel Emulator, which helps device makers ensure that their products deliver optimum performance in the field.
The IPC – Association Connecting Electronics Industries® awarded its first IPC J-STD-004 Qualified Products Listing certificate to Indium Corporation’s facility in Clinton, NY. The IPC program was developed to promote supply chain verification, and provides audit, inspection, testing, and advisory services to suppliers throughout the electronics industry.
Coilcraft, Inc., Cary, IL, recently donated two sets of Power Magnetics Parts Cabinets to the Department of Electrical and Computer Engineering at The University of Illinois, Urbana-Champaign for use in undergraduate- and graduate-level Power Electronics Labs.
Precipart Group, Farmingdale, NY, a global supplier of precision custom mechanical components, gears, and motion control assemblies for medical technology, aerospace, homeland security and industrial markets, has changed the name of its ALCprecision operating company to Precipart. The name change coincides with the launch of a new Precipart informational website at www.precipart.com .
