Here is the latest batch of news from the medical products community. Please click the link for more.
Regulatory Approvals and Launches
Boston Scientific, Natick, MA, has won FDA approval for its newest suite of cardiac devices, including next-generation defibrillators and heart failure devices. The newly approved devices include the DYNAGEN™ MINI and INOGEN™ MINI ICDs, as well as the DYNAGEN™ X4 and INOGEN™ X4 CRT-Ds.
ASTM International, West Conshohocken, PA, Committee F04 on Medical and Surgical Materials and Devices has approved a new standard for a metallurgical implant material useful in surgical applications. ASTM F3046, Specification for Wrought Titanium-3Aluminum-2.5Vanadium Alloy for Surgical Implant Applications (UNS R56320), was developed by Subcommittee F04.12 on Metallurgical Materials. See http://www.astm.org/Standards/F3046.htm .
Integra LifeSciences, Plainsboro, NJ, has received FDA 510(k) clearance to use its Camino Flex ventricular catheter in magnetic resonance imaging scans. The new clearance means that patients undergoing neuromonitoring with Camino Flex can undergo scans without having to have the catheter removed.
Polymicro Technologies™, a subsidiary of Molex Inc., Lisle, IL, has achieved registration and compliance with the FDA 21 CFR 820 Quality System Regulation for its portfolio of products including silica capillary tubing, specialty optical fibers, optical and capillary assemblies, and discrete micro components, in addition to packaged and sterilized components.
Edwards Lifesciences, Irvine, CA, says that its next-generation Intuity Elite valve system has received CE Mark approval. The company says that the flexible, lower-profile delivery system allows surgeons to make smaller incisions, reducing cross-clamp time, and improving hemodynamics.
DePuy Synthes Power Tools, Palm Beach Gardens, FL, announced the global launch of the Anspach® EG1™ High Speed Electric System, a next-generation high-speed electric drill with multiple attachments and accessories, designed for use in neurosurgery, otology, and spinal procedures.
Surgical Theater, LLC, Cleveland, OH, launched its new Surgical Navigation Advanced Platform (SNAP), which integrates with operating room technology to provide advanced 3D capabilities and virtual reality guidance to help surgeons determine the best pathway to remove cerebral tumors and treat vascular anomalies.
Calgary Scientific Inc., Calgary, Canada, a leader in web and mobile diagnostic medical imaging and cloud enabling solutions, announced FDA Class II clearance for its image-viewing solution, ResolutionMD, which enables doctors to securely view patient images and reports from a wide variety of computers and mobile devices.
Escalon Medical Corp., Ardmore, PA, has received FDA 510(k) clearance for its new tablet-based ultrasound imaging system, the Sonomed Escalon VuPad™.
Seno Medical Instruments, Inc., San Antonio, TX, which is pioneering the development of opto-acoustic technology to improve the process of diagnosing breast cancer, has received the CE Mark for Imagio®, a new opto-acoustic imaging system.
ConvaTec, Greensboro, NC, a leading global medical products and technologies company, launched an innovative new ostomy pouch that brings Moldable Technology to ostomates who prefer a one-piece pouch.
BrainScope Company, Inc., Bethesda, MD, a medical neurotechnology company developing a new generation of instruments to assess traumatic brain injury, has been successfully certified to ISO 13485:2003, the international standard for comprehensive quality management systems for the design and manufacture of medical devices.
Saint-Gobain Seals, Garden Grove, CA, reports that its Rulon® 1439 material has achieved full USP Class VI certification, complying with stringent disposable and reusable medical device requirements.
Bluestar Silicones, Lyon, France, a global integrated silicones supplier, has achieved certification under the Responsible Care® Management System at its US manufacturing facility located in York, SC.
Medicrea, Lyon, France, announced the launch of its UNiD patient-specific osteosynthesis spinal rod system in Europe. The system allows surgeons to contour the device to a patient’s unique spinal anatomy prior to surgery and get a custom-made rod for implant.
GE Healthcare, Waukesha, WI, announced it has received FDA 510(k) clearance of its Revolution* CT, which, it says, will enable physicians to diagnose even the most challenging patients.
RevMedX, Inc., Wilsonville, OR, reports that the FDA has approved marketing of its XSTAT, an expandable, multi-sponge wound dressing to control the bleeding from certain types of wounds received in battle. For military use only, the XSTAT is a temporary dressing for wounds in areas that a tourniquet cannot be placed, such as the groin or armpit. The dressing can be used up to four hours, which could allow time for the patient to receive surgical care.
ZipLine Medical, Campbell, CA, has received the CE Mark for Europe, Todokede premarketing notification for Japan, and Korean Ministry of Food and Drug Safety approval to sell its patentedZip®non-invasive surgical skin closure device. Zip is already FDA-cleared.
Breathe Technologies, Inc
DETECTO, Webb City, MO, has achieved EN ISO 13485:2012 certification for its design and manufacture of medical scales.
Fluke Biomedical, Everett, WA, a global provider of test and measurement equipment and services, announced the launch of its IDA-1S Infusion Device Analyzer, a portable, battery-operated tool that allows for speedy verification of infusion device performance.
Honeywell, Morris Township, NJ, announced several senior leadership changes: Roger Fradin was promoted to Vice Chairman of the company responsible for advancing Honeywell's merger and acquisition strategy. Andreas Kramvis was promoted to Vice Chairman where he will globally deploy HOS Gold, advance its software initiative and drive expansion. Alex Ismail was named president and CEO of ACS. Darius Adamczyk was named President and CEO of PMT, which now includes HPS, UOP, and Advanced Materials. Tom Szlosek was named Senior Vice President and CFO. Dave Anderson, Senior Vice President and CFO, will retire after a decade at Honeywell.
Integra LifeSciences Holdings Corporation, Plainsboro, NJ, announced that Mark Augusti has joined as CVP, President, Orthopedics and Tissue Technologies. He will be responsible for the management of its Spine and Extremities divisions.
DfR Solutions, LLC, Beltsville, MD, a leader in quality, reliability, and durability solutions for the electronics industry, has appointed Dock Brown to its Senior Technical team. He will support clients across the electronics industry with a specific focus in the aerospace, avionics, and medical device markets.
Ilana Odess, Chief Executive Officer and Founder of Woven Orthopedic Technologies, Manchester, CT, received the top award for Entrepreneurial Innovation and Leadership by The Connecticut Technology Council at its 2014 Women of Innovation Awards dinner March 27.
STENTYS, Princeton, NJ, a medical technology company developing and commercializing stents to treat acute myocardial infarction, has appointed Dianne Blanco, CEO of Orteq, London, UK, to its Board of Directors. Orteq Ltd is a medical device company specializing in novel biodegradable polymers.
Semiconductor Manufacturing International Corporation, Shanghai, China, the country's largest semiconductor foundry, announced that Hiroshi Ogawa was appointed as General Manager of SMIC Japan Corporation.
Sanovas Inc., Sausalito, CA, a life sciences accelerator developing and commercializing next-generation micro-invasive diagnostics, devices, and drug delivery technologies, appointed Jeff Heer to serve as Chief Operating Officer.
Eldon James Corporation, Denver, CO, a leading manufacturer of PVC FREE tubing and connectors, announced the promotion of Chene Cramer to the position of general manager. He previously led the engineering department.
Intelligrated, Mason, OH, a leading North American-based automated material handling solutions provider, announces three new additions to its Brazilian office. The company appointed Eduardo Tedesco as general director, Ricardo Viana as senior sales engineer, and Claudio Meirelles as operations manager.
Uroplasty, Inc., Minneapolis, MN, a medical device company that develops, manufactures, and markets innovative proprietary products to treat voiding dysfunctions, announced that Daniel P. Merz has joined the company as Vice President of Healthcare Affairs.
Orthofix International N.V., Lewisville, TX, a global medical device company providing reconstructive and regenerative orthopedic and spine solutions, has appointed David E. Ziegler as Interim Chief Financial Officer.
ClearFlow Inc., Anaheim, CA, a designer and manufacturer of a new generation blood evacuation system announced that Michael Cox has joined the Company as Vice President of Sales, North America.
Precision Polymer Engineering, Blackburn, UK, a leading manufacturer of advanced elastomer O-rings and components, announced that it will open a new manufacturing site in Brenham, TX, later this year.
Pregis Corporation, Deerfield, IL, announced a multimillion dollar investment for a new proprietary and custom-built converting line at its Plymouth, IN, manufacturing plant. The new line is expected to be operational by the end of Q3 and will double previous production capacity.
Ethicon BiosurgeryIreland, Dublin, part of the Johnson & Johnson group, plans to develop a manufacturing facility providing approximately 270 jobs at the National Technology Park, Plassey, Limerick, Ireland.
InnoSound Technologies, Inc., Richmond, VA, a manufacturer and distributor of ultrasonic surgical equipment and devices, has selected the Virginia Biotechnology Research Park in Richmond as the location for its first sales and service facility.
Photo Stencil, LLC, Colorado Springs, Co, a leading full-service provider of high-performance stencils and tooling, has just taken delivery at its facility in Guadalajara, Mexico, of its third system for laser cutting stencils. The facility produces laser and NiCut stencils for the semiconductor packaging, printed circuit board, and solar industries.
Orchid Orthopedic Solutions, Holt, MI, a worldwide leader of medical device outsourcing services, has located a new manufacturing facility in Jackson, TN, to support its machining of complex instruments.
CSA Group, Toronto, Canada, a leading global provider of standards development, testing and certification services, and HCT Co. Ltd., Seoul, S. Korea, a leading provider of certification and compliance testing, announced a new alliance that will enable both organizations to expand one-stop testing and certification services for electronics and electrical appliances, providing Korean manufacturers access to global markets.
Siemens Industry, Inc., Elk Grove Village, IL,announced the appointment of TechSolve, Cincinnati, OH, as a solution partner to offer solutions to customers with Sinumerik CNCs who are interested in or have already implemented MTConnect into their factories. TechSolve would apply its Adapter software to an existing machine’s CNC, which enables data transfer through an MTConnect Agent, then the data can then be stored locally or cloud-based.
Sterling Computers Corporation, Norfolk, NE, a leading provider of IT sales and services, announced its strategic partnership with 3D Systems, Rock Hill, SC. 3D Systems was the first to market in 3D printing and remains an innovator in 3D printing-centric, design-to-manufacturing solutions.
AMETEK, Inc., Berwyn, PA, a leading global manufacturer of electronic instruments and electro-mechanical devices, and Zygo Corporation, Middlefield, CT, a leading provider of optical metrology solutions, high precision optics, and optical assemblies, have entered into a definitive merger agreement under which AMETEK will acquire Zygo.
Analogic Corporation, Peabody, MA, enabling the world's medical imaging and aviation security technology, has entered into a distribution agreement with D&K Technologies Ltd., Hong Kong, developer of the BioJetTM Solution, a revolutionary 3D MRI transrectal ultrasound fusion technology. Analogic will distribute the BioJet system for use with its BK Flex FocusTM ultrasound systems, for assistance during prostate biopsies, in Austria, Belgium, Denmark, Germany, Great Britain, Luxemburg, North America, Sweden, Switzerland, and The Netherlands.
Medline Industries, Inc., Mundelein, IL, a manufacturer and distributor of health care products, has acquired the anterior cervical fusion distraction pin business from Amendia, Marietta, GA, a recognized leading provider of innovative Class II and Class III medical devices used in spinal surgical procedures.
Matrix Surgical USA, Atlanta, GA, has partnered with cosmetic surgeon, Dr. Michael Yaremchuk, Boston, MA, to manufacture and distribute his new line of patented polyethylene facial implants. The craniofacial implant system will be marketed under the OMNIPORE® brand.
3D Systems Corporation, Rock Hill ,SC, a leading provider of 3D printing centric design-to-manufacturing solutions, announced that its has entered into a definitive agreement to acquire Robtec, Sao Paulo, Brazil, the largest Latin-American additive manufacturing service bureau and the leading 3D printing and scanning products distributor in the region.
Littelfuse, Inc., Chicago, IL, a global leader in circuit protection, has introduced the Littelfuse iDesign™ Online Fuse Design and Selection Tool, a robust, web-based tool designed to help circuit designers identify the optimal electronic fuses for their projects. To use the Littelfuse iDesign tool, simply register for a free online account at https://littelfuse.transim.com/login.aspx . In addition, Littelfuse was recently recognized with a Supplier of the Year Award from Arrow Electronics, Inc., Englewood, CO, a global provider of products, services and solutions to industrial and commercial users of electronic components and enterprise computing solutions.
Phillips-Medisize, Hudson, WI, announced that its Suzhou, China, facility has commenced full-scale production of a finished injector pen for use in China and other Asian markets. The completion of the commercialization of this project represents the cornerstone of the company’s recently announced “China for China” strategy.
Nordson ASYMTEK, Carlsbad, CA, a leader in dispensing, coating, and jetting technologies, has received both the Service Excellence Award and the New Product Introduction Award for its new Spectrum™ II dispensing system at IPC APEX 2014, Las Vegas, NV. This is the 10th time in the 11-year history of the Service Excellence Awards that Nordson ASYMTEK has won.
IPC, Bannockburn, IL, presented six long-time volunteers with IPC President’s Awards. They were: Daniel Gamota, Jabil Circuit, Inc.; E. Eddie Hofer, Rockwell Collins; Gerard O’Brien, Solderability Testing & Solutions, Inc.; Richard Rumas, Honeywell Canada; Tony Senese, Panasonic Electric Works; and Donald Walsh, Uyemura International Corp.
INFINITT, Phillipsburg, NJ, a provider of image and information management technologies for healthcare, signed a 10-year agreement with the National Football League to provide on-demand access to players’ medical images. INFINITT Smart-NET, a web-based hosting picture archiving and communications system that maintains digital copies of images across a network of data centers, will enable instant viewing of images from any stadium, team facility, or physician’s office as long as the user has proper credentials for image access.
MC Assembly, Palm Bay, FL, a leading mid-tier electronics manufacturing services provider, announced that Zeiss, Jena, Germany, a global leader in products and services in the medical technology business, has honored MC Assembly with its coveted 20/20 award.
Point Grey, Richmond, Canada, announced new plug-and-play interoperability between its Grasshopper®3 and Flea®3 USB3 Vision cameras and Matrox Imaging Library, a comprehensive software tool for developing machine vision, image analysis, and medical imaging software applications.
VadaTech, Henderson, NV, a manufacturer of embedded boards and complete application-ready platforms, has a new Web site (www.vadatech.com ), which features navigation from both a product function and a technology form factor allowing users to search for common architectures like MicroTCA, VPX, and AdvancedTCA or by products such as FPGAs, processors, switches, and more.
ResMed, San Diego, CA, which develops products to treat sleep-disordered breathing and other respiratory conditions, has won two Red Dot Product Design Awards for 2014—one for its AirFitTM P10 nasal pillows mask and one for its soon-to-be-launched AstralTM 150 life support ventilator.
Boothroyd Dewhurst, Inc. Wakefield, RI, will host the 29th annual International Forum on Design for Manufacture and Assembly (DFMA) on June 4-5 at the Crowne Plaza Hotel, Providence-Warwick, RI. For more information, see www.dfma.com/forum/index.html .
Keithley Instruments, Cleveland, OH, a leader in advanced electrical test instruments and systems, is offering a free, web-based seminar titled “Optimizing Semiconductor Measurements and Test Times.” To register for this web-based seminar, visit http://www.keithley.com/promo/ws/1403 .
ATW Companies, Warwick, RI, a leading provider of engineered metal manufacturing solutions, continues to advance its lean culture through continued training in Lean manufacturing processes and Lean new product introduction throughout the organization. Sigma Breakthrough Technologies Inc., San Marcos, TX, a leading consultant on business process improvements, has been working with the company to advancing Lean process improvements.
Xilinx, Inc., San Jose, CA, announced that its "Best Supplier Award" was given to Taiwan Semiconductor Manufacturing Company Ltd. (TSMC), the world's leading semiconductor foundry, in recognition of TSMC's outstanding performance as a strategic partner and supplier in 2013. Xilinx presents this award annually to recognize a key supplier, and this is the second consecutive year that TSMC has received this honor.
Anomet Products, Inc., Shrewsbury, MA, introduces its new website www.anometproducts.com , which offers a wide range of clad metal and metal alloy wire, rod, and strip compositions for use in virtually all industries including medical devices, cathodic protection, and electronics.