Here is the latest batch of news from the medical products community. Please click the link for more.
Regulatory Approvals and Launches
FUJIFILM SonoSite, Inc., Bothell, WA, received 510(k) clearance from the FDA for its newest generation of point-of-care ultrasound: the X-Porte™ Ultrasound Kiosk, and will begin shipping the X-Porte kiosk in the US effective immediately.
Seventh Sense Biosystems , Cambridge, MA, has received the CE Mark approval for its Touch Activated Phlebotomy blood-collection system.
Bruin Biometrics, LLC, Los Angeles, CA, has received the CE Mark for its SEM Scanner, a Class IIA medical device intended to detect localized tissue edema and pressure-induced tissue damage that may lead to pressure ulcers.
NeuroPace, Inc., Mountain View, CA, announced that the FDA has granted premarket approval for the NeuroPace® RNS® System, a novel, implantable therapeutic device that delivers responsive neurostimulation to treat people with epilepsy.
Phillips-Medisize, Hudson WI, reported that its China facility recently registered with the China Food and Drug Administration, which will result in shorter China product registration for western companies that manufacture products in its facility for sale in China, and could potentially shorten product registration for sale in China from 2 years to 3 to 6 months. The Phillips-Medisize Mexico facility also received ISO 13485 certification from DEKRA.
Fenwal, Inc., a Fresenius Kabi company, Lake Zurich, IL, received FDA 510(k) clearance for its Alyx®system software version 3.1, which gives the system a protocol for closed system plasma collection.
Sorin Group, Milan, Italy, has received CE (Mark approval for the XL version of Perceval, a bioprosthetic device designed to replace a diseased native or malfunctioning prosthetic aortic valve.
Dallen Medical, San Clemente, CA, has received FDA 510(k) clearance for its Tensyn™ band for fixation of ankle syndesmosis.
Evena Medical, Los Altos, CA, a leader in high-definition imaging for venous access, announced the launch of its Eyes-On™ Glasses System, a one-of-a-kind point-of-care wearable unit which enables nurses at the bedside to see “through” a patient’s skin to the vasculature beneath.
NEC Display Solutions of America, Itasca, IL, a leading provider of commercial LCD display and projector solutions, announced that the FDA has granted 510(k) clearance for its 21-inch MultiSync® MD210C2 medical-grade monitor, built for displaying and viewing of digital images for diagnosis by trained physicians.
W.L. Gore & Associates, Flagstaff, AZ, announced the launch of theGORE ACUSEAL Vascular Graftfor vascular access, which expands treatment options for earlier removal or possible avoidance of a central venous catheter.
OrthAlign, Inc., Aliso Viejo, CA, received 510(k) clearance from the FDA to market its OrthAlign Plus™ system, a single-use navigation device for total hip arthroplasty and total knee arthroplasty surgeries.
Xilinx, Inc., Nuremberg, Germany, announced its comprehensive functional safety design package for industrial, automotive, medical, aerospace and defense applications according to IEC 61508 and ISO 26262 safety standards. Xilinx’s functional safety package includes a TÜV SÜDcertified design methodology and tools that increase design productivity and reduce certification risks.
Precision Extrusion, Inc., Glens Falls, NY, a contract manufacturer of medical device components and sub-assemblies based on thermoplastic tubing, announced the company's successful registration on a first audit to the ISO 13485:2003, Quality Management Standard for Medical Devices.
Leadership News
The ExOne Company, North Huntingdon, PA, a global provider of three-dimensional printing machines and printed products to industrial customers, announced that Brian W. Smith will join ExOne as Chief Financial Officer and Treasurer on January 1, 2014.
Sandvik Coromant, Fair Lawn, NJ, a leading producer of cutting tools for the metal cutting industry, recently appointed Eduardo Martin as President of Market Area Americas, which includes Argentina, Brazil, Canada, Chile, Mexico and the United States. He succeeds John Israelsson who moved to the position of President within Sandvik Hyperion.
Kem Hawkins, president of Cook Group Incorporated, announced that Pete Yonkman will lead Cook Group’s medical companies as president of Cook Medical, Bloomington, IN. Yonkman, a 12-year veteran of the company, most recently served as Executive Vice President overseeing Cook Medical’s 10 strategic business units.
IlluminOss Medical, East Providence, RI, which is pioneering the development of minimally invasive, customized orthopedic implants to stabilize and treat bone fractures, has appointed Frederick Tobia as Vice President Regulatory and Clinical Affairs.
Resonetics, Nashua NH, a leading supplier of polymer laser micromachining services and systems for the life sciences industry, announced that Scott Davis has joined the company as Director, Quality Assurance and Regulatory Affairs.
WITTENSTEIN North America, which develops motion control systems, welcomes Dr. Lars Aldinger to the US, as he begins a new role as Vice President of Production, after serving as Director of Technology Development at WITTENSTEIN AG in Switzerland. He will be responsible for all supply chain activities within the WITTENSTEIN group in North America, including machining, assembly, purchasing, logistics, quality assurance, and repair/maintenance service.
The Metal Powder Industries Federation has elected Richard Pfingstler, CEO, Atlas Pressed Metals, DuBois, PA, as President. Three associations also installed new presidents during the annual meeting. John F. Sweet, PMT, President, Powder Metal Division, FMS Corporation, Minneapolis, MN, was elected President of the Powder Metallurgy Parts Association; Patrick J. McGeehan, Vice President and General Manager, Specialty Metal Products, Ametek, Inc., Robesonia, PA, was elected President of the Metal Powder Producers Association; and David V. Bowles, General Manager and President, Pressure Technology, Inc., Warminster, PA, was elected President of the Isostatic Pressing Association.
Expansions/Moves
Valtronic USA, Solon, OH, recently qualified a new 288 square ft. bioburden ISO Class 8 clean room, which allows the company to package electronic and mechanical assemblies in a pouch ready for sterilization.
Ionbond, one of the world's leading providers of PVD, CVD, and PACVD coating services and CVD coating equipment, recently opened its new corporate headquarters offices in Zürich, Switzerland, following the acquisition of the company by IHI Corporation of Japan at the end of last year.
PCC (Plastics Color Corporation), Calumet City, IL, a leading supplier of color concentrates, compounds, custom-functional masterbatches and other polymer technologies, has added two new production lines to its Asheboro, NC, manufacturing facility.
Intelligent Software Solutions, Colorado Springs, CO, is launching an Open Source consulting business called Springblox that will offer open source software integration services, training, and production support. The consulting business will work with commercial enterprise customers, as well as its traditional federal base.
Mergers/Acquisitions/Collaborations
Wright Medical Group, Inc., Arlington, TN, a leader in surgical solutions for the foot and ankle market, has completed its acquisition of Biotech International, a leading French orthopaedic extremities company.
Richard Wolf Medical Instruments Corporation, Vernon Hills, IL, and MAQUET, Rastatt, Germany, have formally launched a non-exclusive sales partnership in the US, which allows both companies to offer complete, high-quality OR integration solutions in the endoscopy market.
Vancive Medical Technologies, Chicago, IL, and CareFusion Corporation, San Diego, CA, announced an exclusive agreement in the US, Canada, and Mexico for the licensing and distribution of Vancive's BeneHold™ Chlorhexidine Gluconate antimicrobial adhesive technology for applications in vascular access.
Littelfuse, Inc., Chicago, IL, the global leader in circuit protection, has reached an agreement with Mouser Electronics, Inc., Mansfield, TX, for Mouser to offer its customers Hamlin Electronics’ extensive line of sensors, reed switches, and reed relays.
Four best-in-class manufacturing companies formed a strategic partnership to reduce risk and simplify management of active medical implant projects. They are: Chameleon Design Solutions, Budd Lake, NJ, design and product development; Esterline Souriau PA&E, Wenatchee, WA, hermetic feedthrus, connectors, and packaging; Litron, Inc., Agawam, MA, supply chain management, assembly, and hermetic sealing; and Valtronic, Cleveland, OH, micro-electronic assembly.
Averna, Montreal, Canada, an industry-leading developer of test solutions and services for communications and electronics device-makers worldwide was selected by the Power Matters Alliance (PMA) as test equipment supplier for its certification program of wireless charging devices. Averna will provide automated testing equipment to certify finished products and to validate products during development. PMA is also partnering with UL (Underwriters Laboratories), AT4 wireless, and TÜV Rheinland.
Axus Technology, Chandler, AZ, a global supplier of CMP and wafer thinning equipment and support services, has acquired several control system product lines from the Moog Industrial Group, including several automation platforms and related products, including amplifiers and touchscreen control systems.
Miscellaneous
Nordson EFD, a Nordson company, East Providence, RI, a global leading precision fluid dispensing systems manufacturer, has received the ASI2013 Readers Choice Award from Adhesives & Sealants Industry magazine for its PICO® 500Hz Dispense Valve. This is the third award for innovation received by Nordson EFD in 2013.
Precision Polymer Engineering, Blackburn, UK, one of the world’s leading manufacturers of high-performance molded elastomer seals, was named Manufacturer of the Year at the prestigious Lancashire Telegraph Business Awards 2013.
Photo Stencil, LLC, Colorado Springs, CO, a provider of high-performance stencils and tooling, has won the 2013 Global Technology Award from Global SMT & Packaging magazine, in the stencils, stencil holders, and nano-coatings category for its NiCutX-SmartRelease™ stencils.
Matrox Imaging, Montreal, Canada, announced the 20th anniversary of its core software product, Matrox Imaging Library, which provides a complete set of tools for the entire process of imaging application development including feasibility testing, prototyping, application creation, and deployment.
Aerotech, Inc., Pittsburgh, PA, a global leader in motion control and precision electromechanical systems, surpassed $1 billion of product shipped since the company’s inception. In just the past year alone, the company initiated and largely completed a multi-million dollar expansion of its world headquarters, established Aerotech China in Shanghai, and is completing a move to larger and upgraded facilities at its UK operations.
