Here is the latest batch of news from the medical products community. Please click the link for more.
Regulatory Approvals and Launches
STX-Med, Herstal, Liege, Belgium, announced that the FDA has approved its device Cefaly, as the first device approved as a preventative treatment for migraine headaches. This is also the first transcutaneous electrical nerve stimulation (TENS) device specifically authorized for use prior to the onset of pain.
Cardiovascular Systems, Inc., St. Paul, MN, has received FDA clearance for its new Diamondback 360® 60cm Peripheral Orbital Atherectomy Systems to treat peripheral arterial disease.
LDR Holding Corporation, Austin, TX, a global medical device company focused on designing and commercializing novel and proprietary surgical technologies to treat spine disorders, announced that the American Medical Association Current Procedural Terminology Editorial Panel has accepted the addition of Category I code 22858X as an add-on code to support two-level cervical arthroplasty procedures.
EOS imaging, Paris, France, a pioneer in orthopaedic 2D/3D imaging, has received the CE Mark for hipEOS, a 3D hip arthroplasty planning software based on EOS biplanar 3D imaging.
AngioDynamics, Latham, NY, received FDA 510(k) clearance for its BioFlo DuraMax chronic hemodialysis catheter, indicated for attaining long-term vascular access for hemodialysis and apheresis.
KARL STORZ Endoscopy-America, Inc., El Segundo, CA, a leader in endoscopy and operating room integration solutions, announced the commercial release of its Flex-Xc Flexible Uretero-Renoscope.
FITBIONIC Inc., Boulder, CO, an upstart developer and manufacturer of next-generation prosthetic technology, has launched its first product, an innovative prosthetic foot that features high load-carrying bearings made of Torlon® polyamide-imide from Solvay Specialty Polymers.
LabStyle Innovations Corp., Caesarea, Israel, has launched a mobile-phone glucose meter to monitor blood sugar levels in diabetics. Dario combines an all-in-one blood glucose monitoring system, a smart phone application (iOS & Android), a website application, and treatment tools, and is initially being launched in New Zealand, Italy , Australia , and the United Kingdom.
SafeOp Surgical, Stamford, CT, has received FDA 510(k) clearance for its EPAD neuromonitoring device.
Surefire Medical, Inc., Westminster, CO, has received FDA 510(k) clearance and the CE Mark for its enhanced line of Surefire Guiding Catheters used in radioembolization and chemoembolization procedures.
Boston Scientific, Natick, MA, announced that its Rebel Platinum Chromium Coronary Stent System has gained CE Mark approval for patients with coronary artery disease.
Integrity Applications, Inc., Ashkelon, Israel, received CE Mark approval to extend its claim from a monthly recalibration to a six-month calibration validity of the GlucoTrack® model DF-F noninvasive blood glucose measurement device.
Medrobotics Corp., Raynham, MA, a medical robotics company, announced today that the Company received the CE mark for the Flex® System and will initiate a limited commercial launch of the product in select European markets.
Leadership News
The Association of Clinical Research Organizations (ACRO). Washington, DC, announced that Karen A. Noonan has joined the association in the newly created position of Vice President, Global Regulatory Policy. ACRO also announced that John Lewis will serve as Senior Vice President, Policy and Public Affairs. For the past five years, he has held the position of Vice President of Public Affairs with ACRO.
Solvay Specialty Polymers, Alpharetta, GA, a leading global supplier of high-performance thermoplastics, has announced several key organizational changes. Solvay has named Maria Gallahue-Worl as Business Manager-Healthcare, Dane Waund as Global Market Manager-Healthcare, and Shawn Shorrock as Director of Global Regulatory Affairs.
GS Medical USA, LLC, Soquel, CA, a manufacturer and global supplier of spinal implants, instrumentation, and surgical solutions, announced changes in its executive leadership team. SK Hong will lead International Sales, and will serve a dual role in managing the company's US business as Vice President of Operations. Mark Cohen has been named Vice President of Sales for the US. Joseph Jin has been named Interim Executive Vice President, and will focus on aligning sales and marketing directives within the Americas.
Oriel STAT A MATRIX , Edison, NJ., announced the appointment of Lisa L. Michels , JD, MSOLQ asGlobal Practice Head for itsMedical Devices and Life Sciences Practice.
Caliber Imaging & Diagnostics, formerly Lucid, Inc., Rochester, NY, has named Daniel Koon to Director of Global Sales Support.
ExOne Company, North Huntingdon, PA, a global provider of 3D printing machines and printed products to industrial customers, has appointed Karlebo Gjuteriteknik AB, Sollentuna, Sweden, as its sales representative in Scandinavian countries for its 3D printing machines and the 3D printing of parts.
Bunting® Magnetics Co., Newton, KS, a producer of precision magnetic products for the worldwide food, recycling, printing, automobile, plastics, and electronics industries, has named Steven Clark as Territory Manager for Standard Products, with sales responsibilities for upstate New York, as well as Maine, Vermont, New Hampshire, Massachusetts, Rhode Island, and Connecticut.
Saudi Basic Industries Corporation (SABIC), Riyadh and Pittsfield, MA, has appointed Sameer Singla as Senior Director of SABIC Innovative Plastics’ Polymershapes distribution unit, Huntersville, NC, a leader in plastic materials distribution.
Theragenics Corporation, Buford, GA, a medical device company serving the surgical products and prostate cancer treatment markets, announced that Mark Kesti has been hired as Vice President of Sales for Galt Medical, Garland, TX, and NeedleTech Products,Inc., North Attleboro, MA. He will lead all sales activities for contract manufacturing, OEM and dealer sales for both companies.
Metallized Carbon Corporation, Ossining, NY, a global leader in the manufacture of oil-free, self-lubricating, carbon-graphite materials, announced that Roxanne Andrian will fill the position of Quality Assurance Manager.
Expansions/Moves/New Abilities
Fresenius Medical Care North America, the world’s largest provider of products and services for kidney dialysis, will bring its East Coast manufacturing operations to Innovation Valley in Knoxville, TN. Fresenius Medical Care will begin moving one production line to the Knoxville facility in September. Actual production at the facility is not expected to begin until early 2016, pending FDA approval of the facility.
Rogan Corporation, Northbrook, IL, known for its true two-shot, TPE, silicone, and insert and overmolding, has expanded its extensive molding capacity with the purchase of two state-of-the-art Wittmann Battenfeld two-shot hydraulic injection molding presses. These new presses, designed for efficient two-shot molding, will also increase Rogan’s ability to meet the increasing market demand for more complex parts and component assemblies, while controlling costs.
JVD, Inc. San Jose, CA, a leader in the design and manufacture of Analog ASIC semiconductors, has announced the availability of additional Analog Front End IP for incorporation into customer products. These new AFEs, designated as SCi209 and SCi210 provide a complete signal path between sensor system and an analog-to-digital converter selected by customer to suit their application needs. They are ideally suited for measuring small currents in applications including bio industry, medical, photonics, and instrumentation.
Coilcraft CPS (Critical Products and Services), Cary, IL, has announced a new product testing and validation service to help electronics manufacturers determine the reliability, repeatability and/or compliance of the electronic components and assemblies they manufacture or procure. For more information, visit www.coilcraft-cps.com/services.cfm .
Portescap, West Chester, PA, has released the MotionCompass, a web-based application designed to provide mini motor solutions based on unique motion requirements for various applications. For more information, visit www.motioncompass.com .
Plastics specialist igus, East Providence, RI, has announced the release of its dry-tech® box, an ingenious sample kit designed to help engineers find the right material bearing for their application. The box contains a set of state-of-the-art card overlays, which filter the bearing choices by criteria, similar to the igus online configurator. For more information, visit www.igus.com/iglide .
Molex Incorporated, Lisle, IL, introduces the Polymicro Technologies™ Capillary Configurator design program for selection of simple to complex capillary tubing products. The free online Capillary Configurator guides users in identifying and submitting product specifications and application parameters which are reviewed by Polymicro’s technical team. For more information, visit www.molex.com/molex/family/polymicro-capillary.jsp .
AGY, Aiken, SC, has introduced over the last two years a number of innovative sizing systems for use in thermoplastic composite applications. Now AGY announces the introduction of a range of S-2 Glass® and E-Glass yarns complete with thermoplastics compatible sizes for use in woven fabrics and a range of other conversion steps. The new sizing systems are designed to work with a wide range of polymer chemistries and are available on a range of fiber diameters and are suitable for a range of high temperature resin systems.
Mergers/Acquisitions/Collaborations
Mikrotron GmbH, Munich Germany, a high performance, high-speed camera company, has recently appointed Uniforce Sales and Engineering, Fremont, CA, Upstate Technical Equipment Co., Inc., Canastota, NY, and MicroDISC, Inc., Yardley, PA, as new distributors for Mikrotron’s range of MV cameras.
DSM, Exton, PA, a global leader in biomedical materials science and regenerative medicine, announced a partnership with Sayan Orthopaedics Ltd., Izmir, Turkey, whereby Sayan will use DSM’s Dyneema Purity® fiber in a trauma treatment device, using different types of Dyneema Purity ultra-high-molecular-weight polyethylene fiber.
ADLINK Technology, Inc., San Jose, CA, which provides a wide range of embedded computing products and services, has acquired PENTA GmbH, Deggendorf, Germany, which designs and manufactures medical embedded PC systems and monitors.
Accellent Inc., Wilmington, MA, , a leading provider of fully integrated outsourced manufacturing and engineering services to the medical device industry, has acquired Lake Region Medical, Chaska, MN, a manufacturer of minimally invasive devices and delivery systems to the cardiology and endovascular markets.
Sparton Corporation, Schaumburg, IL, a design and manufacturing company using state-of-the-art technologies to develop electromechanical devices for OEMs in the Medical and Biotechnological markets, has acquired Aubrey Group, Inc., Irvine, CA, a provider of medical device controllers, RF generation, and pumps and disposables.
Miscellaneous
NewAge Industries, Inc., Southampton, PA, a global plastic tubing manufacturer, marks the 60th anniversary of its founding. The company started as a distributorship in 1954 and later began manufacturing its own plastic and rubber tubing products for industries such as medical, biopharmaceutical, industrial, chemical, and food and beverage.
Nelipak Healthcare Packaging, Cranston, RI, a leading provider of custom thermoformed medical device and pharmaceutical packaging launch dedicated YouTube channel with introduction of Process Validation information video series. This informational series is available at: https://www.youtube.com/user/NelipakHealthcare .
Exostar, whose cloud-based solutions enable secure, cost-effective business-to-business collaboration, announced that Parexel, Waltham, MA, is the latest clinical research organization to become a member of Exostar’s Life Sciences community.
Teratech Corporation , Burlington, MA, announced the launch of its new website dedicated to providing customers with ultrasound products, educational resources, and training options to best suit their needs. See: www.terason.com
Clear Catheter Systems, Inc., Anaheim, CA, has changed its company name to ClearFlow, Inc., and relocated from Oregon to California. The new name reflects a renewed focus on eliminating acute, sub-acute, and chronic postoperative complications of current high failure-rate wound drainage tubes.
AAMI, the Association for the Advancement of Medical Instrumentation, is planning to open AAMI University this June, designed to serve as the go-to training center for medical device and healthcare technology management (HTM) professionals. For more information, visit http://university.aami.org
REGO-FIX, Indianapolis, IN, inventor of the original ER collet system and a world leader in the manufacture of Swiss precision tooling, was recently honored with the prestigious Prix SVC award from the Swiss Venture Club for excellence in innovation, business performance and sustainable development.
DELO® Industrial Adhesives, Windach, Germany, won the German Industry’s Innovation Award in the category “SMEs” for its research activities to reduce reflections on displays with the help of transparent adhesives.
Interface Catheter Solutions, Laguna Niguel, CA, has released a new white paper “Consistent Repeatability in Welding for Balloon Catheter Manufacturing”. For more information, visit www.medicalballoonexperts.com .
The new medical school at Western Michigan University, Kalamazoo, will be named after the founder of the medical technology company Stryker Corp.The Western Michigan University Homer Stryker M.D. School of Medicine will welcome its first class this fall.
