Here is the latest batch of news from the medical products community. Please click the link for more.
Regulatory Approvals and Launches
Argo Medical Technologies, Inc., Marlborough, MA, and Yokneam Ilit, Israel, reports that the FDA has allowed marketing of its ReWalk, the first motorized device intended to act as an exoskeleton for people with lower body paralysis due to a spinal cord injury.
Ulrich Medical USA Inc., Chesterfield, MO, has launched its uCentum comprehensive posterior system in the US for open and minimally invasive spinal fusion applications.
Edwards Lifesciences Corporation, Irvine, CA, reports that the FDA has approved its Sapien XT transcatheter aortic heart valve to treat high-risk and inoperable patients with severe aortic stenosis.
InspireMD, Inc., Boston, MA, a leader in embolic protection systems (EPS), has received European regulatory approval to resume the manufacturing of its MGuard Prime EPS stent with a modified stent securement process . The company also received approval to modify and re-deploy existing MGuard Prime EPS stents that have been returned by clinical and commercial sites worldwide.
ERT, Philadelphia, PA, a leading global solution provider for patient safety and efficacy endpoint data collection, has received FDA 510(k) clearance to market its AM3® GSM devices, which provide a wireless option for clinical trial patients to communicate key spirometry data, in respiratory clinical trials.
Devon Medical Products, Inc., King of Prussia PA, an ISO 13485 medical device manufacturer, designer, and distributor, announced that it has received FDA 510(k) clearance to market its extriCARE® 3600 Negative Pressure Wound Therapy pump and foam dressing kit.
FUJIFILM Medical Systems U.S.A., Inc., Stamford, CT, a global leader in technology innovation, has received FDA 510(k) clearance for its Aspire Cristalle imaging system for digital mammography.
Sparta Systems, Inc., Hamilton, NJ, a global leader in enterprise quality management solutions (EQMS), has received ISO 9001:2008 certification for the design and distribution of its software. The company is the first and only major EQMS vendor to have received this certification.
Leadership News
Mack Molding, Arlington, VT, announced that Ray Burns, president of Mack's Southern Division, announced plans to retire as of September 1. He has been with Mack for 33 years, and as president of the division for the past 17 years. Bryan Campbell, Mack North headquarters plant manager, has been named as the new president of the Southern Division. Replacing Campbell, Rich Hornby was promoted to plant manager of the Mack Molding headquarters plant in North Arlington, VT.
Medtronic, Inc., Minneapolis, MN, announced that it is promoting Geoff Martha, currently Senior Vice President for Strategy and Business Development, to Chief Integration Officer as it proceeds with its acquisition and integration ofCovidien plc, Dublin, Ireland.
NeoChord, Inc., Eden Prairie, MN, a medical device company focused on minimally invasive mitral valve repair, has appointed David Chung as President and Chief Executive Officer, effective immediately, replacing John Seaberg, who resigned. The company also announced that Michael Fulton, a company director, has been elected as Chairman of the Board.
Sunshine Heart, Inc., Eden Prairie, MN, an early-stage medical device company focused on developing, manufacturing, and commercializing its C-Pulse Heart Assist System to treat heart failure, announced the appointment of Brian Brown to the position of Senior Vice President of Operations and Technology.
Sunstone Circuits,Mulino, OR, a leading printed circuit board prototype solutions provider, has named Dennis Hammer as Quality Assurance Manager, where he will manager product quality, continuous improvement, and process analysis.
HLT, Inc., Maple Grove, MN, a medical device company developing leading-edge transcatheter aortic valve replacement therapy, announced the addition of Kevin Bassett as General Manager.
Cohera Medical, Inc.,Pittsburgh, PA, a leading innovator and developer of absorbable surgical adhesives and sealants, has appointed Richard W. Pascoe to the company’s Board of Directors.
Benvenue Medical, Inc., Santa Clara, CA, a developer of minimally invasive solutions for spine repair, has named Gil Kliman, MD, from InterWest Partners to its Board of Directors.
Expansions/Moves
GW Plastics, Bethel, VT, a top contract manufacturer in the healthcare market, announces the expansion of its manufacturing facility in Dongguan, China. Early next year, GW will relocate its existing operations into a new 125,000 square foot building, which is scheduled for completion in the first quarter of 2015.
Auer Precision Stamping Inc., Mesa, AZ, a provider of medical device contract manufacturing services, has installed additional ISO 14644 Class 7 cleanroom capacity to expand production for thin film and polymer-based medical devices.
Rhythmlink International, LLC, Columbia, SC, a medical device manufacturing company specializing in devices that help connect patients to machines to record or elicit physiologic information, announced a major expansion of its Columbia facility that will include a world class automated packaging line in a new 1,500sf ISO 8 Certified, Class 100,000 cleanroom.
Medacta USA, a subsidiary of Medacta International, a global leader in the design of innovative joint replacement and spine surgery products, announced the opening of its new headquarters in Chicago, IL.
Norman Noble, Inc., Highland Heights, OH, a medical device contract manufacturer, has expanded its Process Development Centers as part of a broader facility expansion. Its Process Development Centers support customers with ultra-precision micromachining of medical devices from initial prototype through all stages of FDA approval to full-scale manufacturing.
Mergers/Acquisitions/Collaborations/Licensing
Medtronic, Minneapolis, MN, one of the world’s leading makers of medical devices, has agreed to purchase Covidien plc, Dublin, Ireland. After completion of the acquisition later this year, both companies will be combined to form Medtronic plc, and will move its headquarters to Ireland to take advantage of the lower tax rate.
Hill-Rom Holdings, Inc., a leading global medical technology company, Batesville, IN, has signed a definitive agreement to purchase TRUMPF Medical, based in Germany, which provides a portfolio of well-established operating room infrastructure products.
LEMO, Ecublens, Switzerland, a global leader in the design and manufacture of precision custom connectors, has acquired Northwire, Inc., Osceola, WI, a specialty cable manufacturer of wire and multi-conductor cable and retractiles for the medical, aerospace and defense, energy, and industrial markets.
TE Connectivity Ltd., Schaffhausen, Switzerland, a world leader in connectivity, announced that it has entered into a definitive agreement to acquire Measurement Specialties, Inc., Hampton, VA, a leading global designer and manufacturer of sensors and sensor-based systems.
AMETEK, Inc., Berwyn, PA, a leading global manufacturer of electronic instruments and electro-mechanical devices, announced that it has completed its acquisition of Zygo Corporation, Middlefield, CT, a leader in non-contact optical metrology. Zygo joins AMETEK as part of its Ultra Precision Technologies Division within AMETEK's Electronic Instruments Group.
DuPont Protection Technologies, Wilmington, DE, and JACOB HOLM & SØNNER HOLDING A/S, Basel. Switzerland, a leading company for spunlaced nonwoven fabrics, announced they have signed a definitive agreement for Jacob Holm to acquire DuPont’s Sontara® business, a global nonwovens business that produces products used in a variety of medical applications.
Polymer Technologies Inc. (PTI), Newark, DE, announced its purchase of Engineered Plastics Solutions Group, Norwood, MA, which will function as PTI’s new Elastomeric Solutions Division specializing in shock and vibration isolators, molded isolation products, and custom elastomeric shock and vibration material development.
Miscellaneous
Newcomb Spring of Canada Ltd., Mississauga, Ontario, Canada, announced that it is celebrating 50 years in operation, serving customers around the world with high quality precision springs, wire forms, and metal stampings.
Heilind Electronics, Wilmington, MA, the largest interconnect distributor in North America, has received the Distribution Excellence Award – Platinum Level Sales from Keystone Electronics, Astoria, NY, a leading manufacturer of electronic interconnect components and hardware.
St. Jude Medical, Inc., St. Paul, MN, a global medical device company, announced that its Nanostim™ leadless pacemaker was awarded the 2014 Innovation Award at Cardiostim 2014 as the industry’s most innovative product in the sector of electrophysiology and cardiac techniques.
Proto Labs Protomold Injection Molding Service, Maple Plain, MN, expands its service to include liquid silicone rubber and metal injection molded stainless steel parts. Proto Labs has applied its proprietary technology to these new processes, making short-run liquid silicone rubber and metal injection molded stainless steel parts available faster than traditional methods.
Connecticut Spring & Stamping, Farmington, CT, a manufacturer of precision parts, announces its newly updated and redesigned website with enhanced navigation features making it easier to find their products, including springs, stampings, wire forms, metal forms, precision machined parts, fineblanked parts, and assemblies. See: www.ctspring.com
FANUC America Corporation, Rochester Hills, MI, introduces the FANUC Certified Education CNC Training program, for schools in North America, designed for students to graduate with the knowledge and real-world skills to be able to run a CNC mill or lathe. This directly addresses the need in manufacturing for skilled CNC operators and programmers. For more information, visit www.fanucamerica.com .
Granta Design, Cambridge, UK, a leader in materials information technology, and ASM International, the world's largest professional society for materials engineering, announced a new Neurological module in the ASM Medical Materials Database™. The new resource covers material selection, substitution, qualification, and regulation used in neurological devices. For more information, visit ASM Medical Materials Database™ .
