Here is the latest batch of news from the medical products community. Please click the link for more.
Regulatory Approvals and Launches
GE Healthcare, Wauwatosa, WI, announced today it has received FDA clearance for its Discovery* IGS 740, a new rail-free mobile angiography system with a 41x41-cm detector, which is the first of this kind of mobile angiography system in the industry to receive FDA approval.
The FDA has granted Intuitive Surgical Inc., Sunnyvale, CA, 510(k) clearance for its da Vinci Sp surgical system, which helps physicians control EndoWrist Sp instruments during urologic surgical procedures.
Siemens Healthcare, Malvern, PA, announced that the FDA has cleared its SOMATOM®Force computed tomography system, which contains two sets of Siemens’ most advanced X-ray tubes and detectors, and extends advanced imaging to all patients.
Monarch Medical Technologies, Charlotte, NC, has won FDA clearance for its EndoTool IV, part of its glucose-management software platform.
Christie Medical Holdings, Inc., Memphis, TN, the inventor and global leader of direct projection vascular imaging systems, unveiled its VeinViewer® Vision2, the first and only vein illumination medical device that uses harmless near-infrared light, DLP®, and other technologies to illuminate an exclusive real-time HD digital image of subcutaneous vasculature and blood patterns directly onto the skin surface.
Shimadzu Medical Systems USA, Torrance, CA, has announced that it has receive FDA 510(k) clearance for its Sonialvision G4 universal digital R/F table system, which is designed to perform a wide variety of medical examinations.
GS Medical USA, LLC, Soquel, CA, a global manufacturer and supplier of spinal implants, and instrumentation, announced that it has received FDA 510(k) clearance and has launched its AnyPlus® T/PLIF Cage lumbar cage system.
Olympus, Center Valley, PAZ, announced the US launch of its next-generation ENDOCAPSULE 10 system for small bowel capsule endoscopy procedures, following FDA 510(k) clearance.
Aurora Spine, Carlsbad, CA, has received FDA 510(k) clearances for 35 mm and 40 mm sizes of its sterile-packed Zip Ultra minimally invasive interspinous fusion system and 35 mm, 40 mm, and 45 mm sizes of Zip MIS.
PENTAX Medical Company, Montvale, NJ, a healthcare industry leader in endoscopic imaging, announced the US and Canada launch of the endoPRO iQ® 7.6, the newest version of its information technology and image management software for endoscopy units. The new software promotes best practices for endoscopic documentation, reporting, and data analysis.
BIOTRONIK, Lake Oswego, OR, a leading manufacturer of cardiovascular medical devices, announced that the FDA has granted approval for its Entovis pacemaker system with ProMRI® technology, which allows patients to undergo MRI scans with a limited exclusion zone.
Leadership News
Contour Semiconductor, Inc., N. Billerica, MA, a provider memory chips, has appointed veteran semiconductor industry executive Saul Zales as Chief Executive Officer.
Nordson ASYMTEK, Carlsbad, CA, a leader in dispensing, jetting, and coating equipment and technologies, announces that its President Pieter Bierhuis has been invited to join the IPC Surface Mount Equipment Manufacturers Association Council. He has been President of the company since 2011.
Welch Allyn, Inc., Skaneateles Falls, NY, a leading medical diagnostic device company, announced that Janie Goddard has joined the company as Executive Vice President, Strategic Business Units and Marketing.
Freedom Innovations, Irvine, Ca, a manufacturer of advanced technology prosthetic devices for lower limb amputees, announced the hiring of John Robertson as Vice President of Research and Development.
Noxilizer, Inc., Baltimore, MD, announced the addition of Robert Contino, Director of US Customer and Technical Service.
Sequana Medical AG, Zurich, Switzerland, a medical device company with innovative fluid management technologies, announced the appointment of Stephen McGill as Vice President of Sales and Marketing.
Metallized Carbon Corporation, Ossining, NY, a global leader in the manufacture of oil-free, self-lubricating, carbon-graphite materials for severe service lubrication applications, announced that Roxanne Andrian will fill the position of Quality Assurance Manager.
Sunshine Heart, Inc., Eden Prairie, MN, announced the appointment of Kimberly Oleson to the post of Senior Vice President, Clinical Affairs, where she will manage all aspects of the company’s US pivotal study for its flagship C-Pulse® Heart Assist System.
Fine Tubes, Plymouth, UK, a world-leading manufacturer and distributor of precision tubes for critical applications, has appointed Bait Al-Aseel to act as its agent in Kuwait.
InfinityQS International, Inc., Fairfax, VA, the global authority on real-time quality and Manufacturing Intelligence, announced the appointment of Martyn Gill as the general manager for Europe.
Bovie Medical, Clearwater, FL, a maker of medical devices and supplies, announced the appointment of Peter Donato as Executive Vice President and Chief Financial Officer.
Sussex Wire, Inc., Easton, PA, a manufacturer of miniature, precision, geometrically complex, cold forming of parts for the medical, electronics, connectors, semiconductors, and glass to metal seal industries, announces the appointment of Madan Mathevan to the position of Director of Engineering.
Noxilizer, Inc., Baltimore, MD, has added Jack Ahrens, Tomotaka (Tommy) Goji, and Charles Immel to its Board of Directors.
AxoGen, Inc., Alachua, FL, a leading medical technology company focused on the peripheral nerve repair market, has appointed Lee Robert Johnston, Jr., as Chief Financial Officer.
Expansions/Moves
Proto Labs, Inc., Maple Plain, MN, a leading online and technology-enabled quick-turn manufacturer, has completed renovations of the Plymouth Industrial Building, Plymouth, MN, its fifth building in the Twin Cities area, and began operations there on April 28.
Phillips-Medisize, Hudson, WI, will be opening a Design Development Center (DDC) in Suzhou, China, later this year. Other investments in the facility planned for 2014 include expanded office space, added molding capacity, and upgrades to mold repair and maintenance capabilities.
Watson-Marlow Pumps Group, Wilmington, MA, the world’s largest peristaltic pump manufacturer, has opened a second US sales office located in Lake Forest, CA. The new office is equipped with a full demonstration center.
FATHOM, Seattle, WA, an advanced technology driven company with an expertise in 3D printing and additive manufacturing, announced that 3D printing services for the Objet500 Connex3 are now available directly at its Seattle-based production center.
Photo Stencil, LLC, Colorado Springs, CO, a leading full-service provider of high-performance stencils and tooling, has added a manufacturing plant in Golden, CO. The new 35,200 sq. ft. facility has three cleanrooms and will be used to manufacture the electroform and more complex stencils needed for the small components and shrinking spaces in advanced semiconductor packaging and SMT applications.
Covidienplc, Dublin, Ireland, has officially opened its Covidien Center of Innovation Turkey (CCI Turkey). Located in Istanbul, the new facility offers clinicians in Turkey and the surrounding region training on advanced procedures and techniques using the latest technology.
Mergers/Acquisitions/Collaborations/Licensing
Zimmer Holdings, Inc., Warsaw, IN, which designs, develops, manufactures and markets orthopaedic reconstructive, spinal, and trauma devices, announced a definitive agreement to acquire Biomet, Inc., Warsaw, IN., which designs, manufactures, and markets surgical and non-surgical products used primarily by orthopedic surgeons and other musculoskeletal medical specialists. The merger will position the combined company as a leader in the $45 billionmusculoskeletal industry. Upon completion of the transaction, David Dvorak will be President and Chief Executive Officer of the combined company.
Phillips‐Medisize Corporation, Hudson, WI, a leading global provider of design and manufacturing services, was acquired by Golden Gate Capital, San Francisco, CA. The company will maintain its global headquarters in Wisconsin, and President and CEO Matt Jennings and the current management team will remain in place.
Proto Labs, Inc., Maple Plain, MN, a leading online and technology-enabled quick-turn manufacturer, has acquired FineLine Prototyping, Inc., Raleigh, NC, a leading provider of additive manufacturing services.
Wytech Industries, Inc., Rahway, NJ, a world leader in the manufacture of fine wire and tubing components for the medical device industry, has acquired Morton Bowen, Inc., Broomfield, CO, a contract manufacturer and supplier of precision components.
Teleflex Incorporated, Wayne, PA, a leading global provider of medical devices for critical care and surgery, has partnered with Intuitive Surgical, Sunnyvale, CA, to manufacture Weck® disposable trocar seals and obturators for the new da Vinci Xi Surgical System, the fourth generation of the da Vinci technology.
VadaTech, Henderson, NV, a manufacturer of products for the embedded computer market, and ADLINK Technology, San Jose, CA, a leading provider of embedded building blocks and intelligent platforms, have announced a partnership. VadaTech will utilize ADLINK’s line of processor boards to complement VadaTech’s switch, chassis, RTM, and specialty products in the AdvancedTCA architecture.
Minnesota Wire, St. Paul, MN, which produces custom wire and cable interconnect solutions, announced a new partnership with Binder-USA, LP, Camarillo, CA, a global supplier of high-quality circular connectors. The companies will cooperate to produce cable solutions that utilize Minnesota Wire’s custom cable design and production capability together with Binder’sconnectors to provide a complete cable assembly solution.
OPS Solutions LLC, Novi, MI, and Electro-Matic Products, Farmington Hills, MI, have entered into a Channel Partner Agreement, with Electro-Matic taking on the Light Guide Systems product line for distribution and sales representation throughout Michigan and Northern Ohio.
Tufts University, Medford, MA, announced that it has licensed a novel silk technology to treat chronic skin wounds to Akeso Biomedical, Inc., Waltham, MA, an early stage medical device company.
Miscellaneous
Frost & Sullivan, Mountain View, CA, has recognized ViOptix, Inc., Fremont, CA, with the 2013 North American Frost & Sullivan Award for New Product Innovation for the development of the T.Ox Tissue Oximeter, a non-invasive, portable device for tissue-oxygen saturation diagnosis and monitoring.
Aries Electronics, Bristol, PA, a US manufacturer of standard, programmed, and custom interconnection products used worldwide, announced that Larsen Associates, San Mateo, CA, has been named Aries’ 2013 Representative of the Year. This is the third time that Larsen has received the designation.
Magnet Applications, Dubois, PA, a subsidiary of Bunting® Magnetics Co., has redesigned its website, to align it with the company's Total Magnetic Solutions concept. The new website contains detailed design data as well as practical information regarding how magnets can be used in medical applications. Visit www.magnetapplications.com .
MoleSafe USA, Millburn, NJ, an advanced melanoma screening and surveillance program, has partnered with the Melanoma Research Foundation to support the organization’s efforts of raising awareness, promoting education, and encouraging early detection through enrolling in melanoma screening programs and performing monthly self-skin exams. MoleSafe will donate $10 to the Melanoma Research Foundation for every screening it conducts in the month of May, which is Skin Cancer Awareness Month.
Miyachi America Corporation, Monrovia, CA, a leading manufacturer of welding equipment and laser processing systems, recently participated in innovative research conducted at Penn State University, on improving designs for articulation in surgical tool tips used in natural orifice transluminal endoscopy surgery.
ON Semiconductor, Phoenix, AZ, driving energy efficient innovations, has announced the availability of new qualified intellectual property on its proprietary ONC18 180 nanometer process technology. The newly qualified circuit blocks will help to minimize the risk of the need for silicon re-spins and help reduce development costs and shorten time-to-market for new designs.
The National Science Foundation selected Xiangrong Shen, Assistant Professor of Mechanical Engineering at the University of Alabama, Tuscaloosa, to receive a CAREER Award for his research into a biologically-inspired, powered robotic prosthesis that could help amputees walk better.
Littelfuse, Inc., Chicago, IL, a global leader in circuit protection, has been honored with a 2013 Global Supplier Excellence Award from TTI, Inc., Ft. Worth, TX. This is the first year Littelfuse has been recognized by TTI in all three geographic regions it serves: the Americas, Asia, and Europe, including Platinum-Level status for North America.
Douglas Electrical Components, Randolph, NJ, has launched a new website to inform customers looking to specify hermetically sealed connectors and wire feedthroughs for vacuum or pressure applications. Visit www.douglaselectrical.com .
A new eight-episode NATGEO Channel TV competition, “Showdown of the Unbeatables”, will feature the unique iStretch® cable from Minnesota Wire, St. Paul, MN in a competitive challenge on the episode to be aired May 23 at 8:00 PM Central. The program pits dueling entrepreneurs and their innovative products against each other.
Littelfuse, Inc., Chicago, IL, a global leader in circuit protection, has named Arrow Electronics, Englewood, CO,its Volume Distributor of the Year for 2013. Littelfuse also named Digi-Key Corporation, Thief River Falls, MN, as its High-Service/Catalog Distributor of the Year for 2013.
Nordson ASYMTEK, Carlsbad, CA, a Nordson company, a leader in dispensing, coating, and jetting technologies, earned two prestigious awards for innovative technology during NEPCON China 2014: the Innovation Award from Electronics Manufacturing Asia and the VISION Award from SMT China magazines.
