Here is the latest batch of news from the medical products community. Please click the link for more.
Regulatory Approvals and Launches
Boston Scientific Corporation, Natick, MA, has received the CE Mark for the Lotus™ Valve System, the company’s advanced transcatheter aortic valve replacement technology for patients with severe aortic stenosis at high risk with surgical valve replacement.
Artistic Plating, Milwaukee, WI, has changed its name to Advanced Plating Technologies and announced that it was recently was certified to the demanding requirements of ISO 13485 for services in medical device manufacture.
SpineGuard, San Francisco, CA, and Paris, France, has obtained additional regulatory clearance from COFEPRIS (the Mexican healthcare regulatory authority) to sell its Curved and Curved XS PediGuard® devices in Mexico. The company had previously received clearances for its Classic and Cannulated PediGuard devices.
BIOTRONIK, Berlin, Germany, announced that its PK Papyrus covered coronary stent system, which is used to treat acute coronary artery perforation, has received the CE mark.
Apple Converting, Inc., Oneonta, NY, specializing in the design and manufacture of innovative flexible packaging products and solutions, has achieved SQF Level 2 Certification for following food safety fundamentals and hazard analysis critical control points.
OrSense Ltd., Petach Tikva, Israel, developer of solutions for non-invasive measurements of various blood parameters, has received FDA clearance for its NBM-200MP, noninvasive hemoglobin and pulse oximetry monitor.
Samsung Electronics America Inc Samsung XGEO GC80, which received 510(k) approval from the FDA earlier this year.
W. L. Gore & Associates, Flagstaff, AZ, announced that the GORE EXCLUDER Iliac Branch Endoprosthesis, the first complete, fully engineered system intended for endovascular treatment of common iliac artery aneurysms, has received the CE Mark. In addition, the FDA has approved the 25 cm GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface to treat symptomatic peripheral arterial disease lesions in the superficial femoral artery.
InControl Medical LLC, Brookfield, WI, a women’s health company with a focus on relief of urinary incontinence, has received two important international quality designations:ISO 13485certification from theInternational Organization for Standardization(ISO), and theCE mark of the European Commission
Topera, Inc Catheter.
Leadership News
Nonin Medical, Inc., Minneapolis, MN, the inventor of finger pulse oximetry and a leader in noninvasive medical monitoring, announced that the company has appointed Richard J. Eagle as Vice President of Sales.
EXSYS Tool, Inc., San Antonio, FL, a provider of high-precision rotary and fixed tool holder solutions for CNC turning centers, recently named John Thomas its territory manager for Pennsylvania, New Jersey, and New York.
The ExOne Company, North Huntingdon, PA, a global provider of 3D printing machines and printed products to industrial customers, has appointed Hermann Otto Suderow SL as its sales representative in Spain and Portugal for its 3D printing machines and the 3D printing of parts.
Express Logic, Inc., San Diego, CA, a worldwide leader in royalty-free real-time operating systems, announced that Ken Maxwell has joined the company as director of engineering in charge of embedded Graphical User Interface tool development.
Sentio, LLC, Southfield, MI, which manufactures and sells a proprietary nerve-mapping tool for use in surgery, announced the appointment of Sean Parker as Vice President of Market Development.
Orchid, Holt, MI, a worldwide leader of medical device outsourcing services, announced the hiring of Tim Lemmen as a division lean leader.
EndoEvolution, LLC, Raynham, MA, a leader in advanced automated suturing device technology, has appointed two new members, Dave Murray and Rob Hoctor, to serve on its Board of Managers.
Intelligrated®, Mason, OH, an automated material handling solutions provider, announced the appointment of Rod Selby to the position of director, Asia Pacific business development.
Kona Medical, Bellevue, WA, and Menlo Park, CA, announced that medical device executive and clinician Omar Dawood, MD, MPH, has joined the company as Chief Medical Officer, Senior Vice President of Medical Affairs.
Röhm GmbH, a global leader in the design and manufacture of high-quality clamping and gripping technology, recently appointed Matthew Mayer to the position of chief executive officer for its North American division, Röhm Products of America, Lawrenceville, GA.
Expansions/Moves
CurveBeam, LLC , Warrington, PA, which provides Cone Beam CT capabilities to the orthopaedic and podiatry specialties, announced the launch of CurveBeam Europe, Ltd., its European headquarters based in London, England.
Phillips-Medisize Corporation, Hudson, WI, announced the completion of a significant facility expansion at its Metal Injection Molding plant on the company’s Menomonie, WI, medical campus, increasing capacity for both medical device and commercial customers.
Welch Allyn, Skaneateles Falls, NY, announced the official establishment of its Europe, Middle East, and Indian Sub-Continent (EMEI) headquarters and a consolidated Operations Center in the Netherlands. The EMEI headquarters is located in Leiden, and the Operations Center is located in Tilburg.
The ExOne Company, North Huntingdon, PA, a global provider of three-dimensional printing machines and printed products to industrial customers, announced the planned opening of a new Production Service Center (PSC) in Las Vegas, NV. As ExOne’s fifth PSC in the US and seventh worldwide, operations are expected to commence in December.
Creganna-Tactx Medical, Galway, Ireland, a global Top 10 provider of medical device outsourcing solutions, announced the opening of its first representative office in Shanghai, China. Leading the new representative office is Jim (Quan) Shen. Along with providing enhanced commercial, technical, and customer-service support to the company’s customers in China, the team will identify and develop leading products customized to local market requirements.
Connecticut Spring & Stamping, Farmington, CT, a manufacturer of precision parts, has expanded its machining capabilities to include multi-axis CNC Swiss machining, ideal for medical applications, including minimally invasive surgical instruments.
Mergers/Acquisitions/Collaborations
AVX Corporation, Greenville, SC, a leading manufacturer of passive components and interconnect solutions, has signed an agreement with leading authorized master distributor, Waldom Electronics, Rockford, IL, to provide small and medium sized distributors with affordable access to AVX's portfolio of best-in-class tantalum, ceramic, film, and niobium oxide capacitors in low minimum order quantities.
Vention Medical, Salem, NH, which specializes in the design, engineering, and manufacturing of complex medical devices and components, has acquired Fast Forward Medical, Plymouth, MN, which focuses on design and early stage manufacturing in the catheter design and assembly space.
Teleflex Incorporated, Limerick, PA, is acquiring Vidacare Corporation, San Antonio, TX, a privately held maker of intraosseous (IO, inside the bone), access devices.
Debiotech SA, Switzerland, and AWAK Technologies Pte Ltd., Singapore, have entered into a partnership agreement regarding the development and manufacturing of a novel miniaturized home hemodialysis machine, based on Debiotech's highly miniaturized home dialysis equipment, and AWAK's novel sorbent technology for fluid purification.
Körber Schleifring, a global provider of grinding machine technology and its North American arm, United Grinding Techologies, Miamisburg, OH, are now one under the new brand name UNITED GRINDING Group – Körber Solutions, a move that expands the company’s global market position as an amalgamation of eight individual company brands.
Miscellaneous
For the fifth consecutive season, igus®, East Providence, RI,is a sponsor for Botball®, an educational robotics program produced by the KISS Institute for Practical Robotics. The Botball Educational Robotics Program provides real-world relevance and development of skills that are immediately applicable in college and demanding industries.
Teleflex Incorporated, Limerick, PA, a leading global provider of medical devices for critical care and surgery, has received the prestigious American Association for Respiratory Care Zenith Award for 2013. Teleflex Medical OEM, has also launched a mobile app for the iPad® that is an on-the-go reference guide to its products, available for free under the search term “Teleflex Medical OEM".
United Grinding North America, Inc., welcomes manufacturers to its Fredericksburg, VA, facility on Nov. 20 from 8:00 am to 5:00 pm to experience the latest technology and trends in PCD tool manufacturing. During this special one-day event, United Grinding will present live demonstrations on the latest hard fine machining solutions. For more information, please visit www.grinding.com .
Affiliated Distributors’ Industrial Supply Division recently named Seco Tools, Troy, MI, its 2013 Supplier of the Year for Marketing Excellence.
IMRIS Inc. , Minnetonka, MN, has received the 2013 Innovation in Medical Devices Award fromMinnesota Business Magazinein recognition for significantly improving medicaltechnologywith the launch of its VISIUS iCT, an intraoperative imaging tool for spinal and orthopaedic surgery.
H.A. Guden, Ronkonkoma, NY, distribution and customization experts for hinges, catches, gas springs, and handles, has launched a new website http://www.hingeguru.com, devoted to making it easier to customize and order hinges.
REM-C (Roboticists, Engineers & Manufacturers Consortium), Mt. Royal, NJ, a non-profit organization, was formed as a university/industry partnership to bridge the gap between university robotic programs and the engineering community. Founding members, including Fischer Connectors, Harmonic Drive, Igus, and maxon precision motors, have identified more than 140 universities in the US with dedicated robotic curriculums. For more information, visit http://www.rem-c.org .
Practice Greenhealth, the nation’s leading membership association devoted to environmentally responsible health care, has announced that B.Braun Medical Inc. will sponsor its DEHP-Free Award, which is given to the one hospital facility or system that demonstrates the most progress towards eliminating DEHP-containing and PVC-containing medical and building products.
The U.S. Department of Commerce is leading a Medical Technologies Trade Mission to Turkey in May 2014 that will introduce US companies to the $3billion Turkish medical equipment market. US companies will travel to Ankara, Izmir, and Istanbul to attend pre-scheduled meetings with potential distributors, end users, industry contacts, and Turkish Government officials, and make hospital tours to understand the healthcare scene in Turkey. The deadline to sign up is December 16, 2013. For more information, visit http://www.export.gov/trademissions/Turkeyhealthcare2014 .
FANUC Corporation, Rochester Hills, MI, the world's most diversified manufacturer of robots, CNCs, and Robomachines, has been named the 26th most innovative company in the world, and the sixth top ranked innovator in Asia by Forbes. This is the third consecutive year that Forbes has named FANUC a top global innovator.
Intelligrated,, Cincinnati, OH, an automated material handling solutions provider, has been named a 2013 Inc. Hire Power Award winner, which recognizes private businesses that have generated the most jobs in the past 18 months. Intelligrated added 435 jobs from Jan. 1, 2012 to June 30, 2013, making it the third-largest private job creator in Ohio and placing second in the US logistics and transportation category.
Surgical teams planning trips to the Philippines to assist typhoon victims can have their instruments and devices refurbished prior to departure at no charge through the non-profit organization Instruments of Mercy, Inc.
