Here is the latest batch of news from the medical products community. Please click the link for more.
Regulatory Approvals, Standards, and Launches
St. Jude Medical, Inc., St. Paul, MN, a global medical device company, announced that it has received FDA approval for its FlexAbility™ Ablation Catheter to treat cardiac arrhythmias, which the company says was developed to conform better to cardiac anatomy.
Albright Technologies, Leominster, MA, a silicone prototype and low-volume production molder, has passed its ISO 13485:2003 mid-term surveillance audit, which specifies requirements for a medical device manufacturer to maintain a quality management system.
Zyno Medical, LLC, Natick, MA, a global medical device manufacturer, has received the CE Mark for its Z-800 Infusion System and Zyno Administration Sets. The Z-800W pump series adds wireless communication capabilities and a cloud-based software interface application.
SCHURTER, Inc., Santa Rosa, CA, a manufacturer of circuit protection, connectors, switches, and EMC products to the electronic and electrical industries, reports that it has passed review by the European Chemicals Agency (EChA) of the 6 new substances added to the List of Substances of Very High Concern, part of the Registration, Evaluation, Authorization and Restriction of Chemicals directive (REACH).
Bell-Everman Inc., Goleta, CA, which creates motion control technologies for a wide variety of automation and metrology systems, has received ISO 9001:2008 certification for the design, manufacture, and support of its precision motion stages and customized embedded motion subsystems.
ECA Medical Instruments, Thousand Oaks, CA, a leading designer and manufacturer of single-procedure torque-limiting and fixed-driver surgical instruments and procedural kits, has received FDA 510(k) approval for its fully disposable spine implant fixation instrument kit to be used with the Intelligent Implant Systems Revolution Spinal System™. This will be available in the second quarter of 2015.
NEC Display Solutions of America, Itasca, IL, a leading provider of commercial LCD display and projector solutions, has received FDA 510(k) clearance for its MultiSync MD210C3 LCD display for diagnostic imaging.
Hospira, Inc., Lake Forest, IL, a leading provider of injectable drugs and infusion technologies, announced that the company has received FDA 510(k) regulatory clearance for its Plum 360™ infusion system with Hospira MedNet™ safety software.
MED-EL Corporation USA, Durham, NC, has received FDA approval for and plans the US launch of its new SYNCHRONY cochlear implant, which has been approved for use with 3.0 Tesla MRI without surgical removal of the internal magnet.
DexCom, Inc., San Diego, CA, a leader in continuous glucose monitoring for patients with diabetes, has received FDA approval for its Dexcom G4® PLATINUM Continuous Glucose Monitoring System with Share.
Bioceptive, New Orleans, LA, a women’s health company, has received FDA 510(k) clearance for its suction cervical retractor, which may replace standard cervical tenaculum forceps used for gynecological procedures.
AliveCor, Inc., San Francisco, CA, has received the CE Mark for itsautomated analysis process (algorithm)to detect atrial fibrillation, a common heart arrhythmia.
Exsurco Medical, Inc., Birmingham, OH, a manufacturer of technologically advanced devices and tools for tissue processing, has been successfully registered according to ISO 13485:2003, the international standard for quality management systems for medical device manufacturing. Exsurco Medical was awarded a Certificate of Registration by BSI Group America, Inc.
Abiomed Inc., Danvers, MA, a leading provider of breakthrough heart support technologies, announced that its Impella RP® (Right Percutaneous) System has received FDA approval under a Humanitarian Device Exemption. This is the first percutaneous single access heart pump designed for right heart support to receive FDA approval.
Dr Robert Califf, currently the vice chancellor of clinical and translational research at Duke University, director of the Duke Translational Medicine Institute, and professor of medicine at Duke University School of Medicine, has been named the U.S. Food and Drug Administration Deputy Commissioner for Medical Products and Tobacco. He will work with the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, the Center for Devices and Radiological Health, and the Center for Tobacco Products.
JenaValve Technology, Inc., Munich, Germany and Irvine, CA, a developer, manufacturer, and marketer of next generation transcatheter aortic valve implantation systems to treat aortic valve disease, has appointed JenaValve Chairman of the Board, Jan Keltjens, as Interim Chief Executive Officer and Executive Chairman.
Dassault Systèmes, Velizy-Villacoublay, France, a world leader in 3D design software, 3D Digital Mock Up, and Product Lifecycle Management solutions, announced that Gian Paolo Bassi has been appointed Chief Executive Officer of its 3D design software brand SOLIDWORKS.
Avedro Inc., Waltham, MA, an ophthalmic pharmaceutical and medical device company, announced that Brian K. Roberts has joined the company as its new Chief Financial Officer.
COR Medical Technologies, Houston, TX, which offers CORcare™, a comprehensive instant outcome support system for rapid and accurate diagnosis, treatment, and follow-up management of patients with diseases involving the cardiovascular system, has appointed Dr. William C. Roberts to its Senior Editorial Board.
William L. (Bill) Clippard, Chairman of the Board, Clippard Instrument Laboratory, Inc., Cincinnati, OH, was recently honored by his alma mater, The Ohio State University Department of Mechanical and Aerospace Engineering, for his commitment to the field of engineering. The university dedicated lab space within the Mechanical Engineering Building as “The Clippard Lab”, in his honor.
Fairview Microwave, Inc., Allen, TX, a global supplier of on-demand microwave and RF components, appointed Lorie Slay to the newly created position of Sales and Service Manager.
The Society of Plastics Engineers (SPE) will present its Business Management Award for outstanding contribution to the plastics industry to Charles A. Sholtis, Chief Executive Officer of Plastic Molding Technology, Inc., El Paso, TX, a manufacturer of small, precision-engineered, injection-molded components used in diverse industries. The award will be presented at SPE’s Annual Technical Conference in March.
Pasternack Enterprises, Inc., Irvine, CA, a leading manufacturer and supplier of RF, microwave, and millimeter wave products, has appointed Tim Galla as Product Manager for Active RF Components.
Geyer Electronics, Munich, Germany, a leading global manufacturer of quality oscillating crystals and oscillators since 1964, announced the expansion of its marketing and sales operations in North America with offices and warehousing in El Cajon, CA.
Integro Technologies Corp., Salisbury, NC, a world leader in vision integration, announces a partnership agreement with SCHOTT-MORITEX North America, Elmsford, NY, a global supplier of illumination and imaging components, to develop innovative and cutting-edge products for industrial machine vision.
Exactech, Inc., Gainesville, FL, a developer and producer of bone and joint restoration products, has acquired an industry-leading computer-assisted surgical technology development and manufacturing firm, BlueOrtho SAS, Grenoble France.
Cohera Medical, Inc., Pittsburgh, PA, a leading innovator and developer of absorbable surgical adhesives and sealants, announced that it has entered into an exclusive sales and marketing distribution agreement with B. Braun, Bethlehem, PA, for its TissuGlu® Surgical Adhesive in Germany, Spain, and Portugal.
ClearFlow Inc., Anaheim, CA, a medical device company that has developed a patented active blood and fluid evacuation system, has signed an exclusive distribution agreement for its PleuraFlow System in the US with Maquet Medical Systems USA, Wayne, NJ.
Natus Medical Incorporated, Pleasanton, CA, a leading provider of healthcare products and services, has acquired Global Neuro-Diagnostics, Flower Mound, TX, a pioneer in EEG diagnostic services.
Helius Medical Technologies, Newtown, PA,and the U.S. Army Medical Research and Material Command have modified an existing Cooperative Research and Development Agreement to speed up the development of the company’s Portable Neuromodulation Stimulator (PoNS) device, a non-invasive brain stimulation device being developed to treat balance disorder in patients with mild-to-moderate traumatic brain injury.
Valtronic, Solon, OH, is a full service global provider of engineering, industrialization and manufacturing for medical devices, introduces, Compendium Solutions, a secure implant & physiological connectivity platform.
Tektronix, Inc., Beaverton, OR, a leading worldwide provider of test, measurement, and monitoring instrumentation, announced that Cerify, the world’s first fully automated system capable of verifying the quality of file-based, compressed digital video and audio content prior to transmission, has received the 2014 Salute Award at the Government Video Expo, which recognizes the best products in the government video category.
Applied Motion Products, Inc., Watsonville, CA, is hostinganew Motion Control Design & Innovation Competition. The company encourages young engineers (university and high school students, robotics and motion control clubs) to participate. Applicants must enter by Friday, February 13 and videos must post by Friday, May 1. Winners will be announced on May 15, 2015. The entry form can be found here: http://www.applied-motion.com/spring-2014-motion-control-competition.
Hundreds of experts from around the world will discuss electronics manufacturing standards in more than 90 standards development meetings from February 22–26, in conjunction with IPC APEX EXPO in San Diego. For more information on IPC APEX EXPO and its standards development activities, or to register, visit http://www.ipcapexexpo.org.
Phillips-Medisize Corporation, Hudson, WI, announced that it has received the prestigious Green Masters distinction from the Wisconsin Sustainable Business Council for the fourth consecutive year, which signifies Phillips-Medisize as a business leader in sustainability scoring in the top 20% of companies that participated this year.
NK Technologies, San Jose, CA, a leading provider of current sensing, ground fault detection and power monitoring products, announces the publication of a new comprehensive catalog featuring its extensive portfolio of current measurement products. A PDF of the catalog can be downloaded here.
SuperPower Inc., Schenectady, NY, has established comprehensive capabilities for testing various types of mechanical/electromechanical properties of its 2G HTS wires, which are used to develop a variety of electric and electromagnetic devices. Applications include high-field magnets, SMES, motors/generators, high current cables, fault current limiters, etc.