Here is the latest batch of news from the medical products community. Please click the link for more.
Regulatory Approvals, Standards, and Launches
Medtronic plc, Dublin, Ireland, the world's premier medical technology and services company, has received FDA approval for its Evera MRI SureScan ICD System implantable cardioverter defibrillator system for use with MRI scans. Medtronic has also launched its ArcTM support catheter in the US, which the company states is the most navigable, 6F tapered support catheter available.
Valtech Cardio, Ltd., Or Yehuda, Israel, an innovator in the development of devices for mitral and tricuspid valve repair and replacement, has received the CE Mark for its Cardioband Mitral Reconstruction System for mitral valve repair.
Boston Scientific, Marlborough, MA, a worldwide developer, manufacturer, and marketer of medical devices used in a range of interventional medical specialties, has received CE Mark approval for its Vercise Primary Cell Deep Brain Stimulation System used for precise neural targeting.
Dexcom, Inc., San Diego, CA, which develops, manufactures, and distributes continuous glucose monitoring systems for diabetes management, received CE Mark approval to market its G5, a continuous glucose monitor that sends data to smartphones.
TheraSolve NV, Diepenbeek, Belgium, a medication adherence innovator, has received a patent from the U.S. Patent and Trademark Office for its innovative MemoPatch®, a self-adhesive dermal patch that gives patients an automated stimulus on the skin when the next dose of medication is needed.
Cook Medical, Bloomington, IN, has received FDA premarket approval for its Zenith Alpha Thoracic Endovascular Graft, to treat patients with isolated lesions of the descending thoracic aorta.
B. Braun Medical Inc., Bethlehem, PA, a leader in infusion therapy and pain management, has received FDA 510(k) clearance for its second-generation, large-volume Infusomat® Space Pump to deliver parenteral fluids, medications, blood, and blood products.
Advanced Catheter Therapies, Inc., Chatanooga, TN, a medical device company specializing in catheter technologies targeting peripheral vascular disease, announced that it has received a second FDA 510(k) clearance for its Occlusion Perfusion Catheter™, a universal targeted therapeutic agent delivery catheter.
St. Jude Medical, Inc., St. Paul, MN, a global medical device company, has received CE Mark approval for its Medical Infinity™ Deep Brain Stimulation (DBS) System and directional DBS lead, the only upgradeable DBS system available to patients battling movement disorders.
Ceterix® Orthopaedics, Inc., Menlo Park, CA, a developer of novel surgical tools to perform minimally invasive orthopaedic procedures, announced FDA 510(k) clearance and US commercial availability of the company’s NovoStitch® Plus meniscal repair system.
Leadership News
President Barack Obama has nominated Dr. Robert Califf as the new commissioner of the U.S. Food and Drug Administration (FDA). He was named deputy commissioner for medical products and tobacco in February. Dr. Stephen Ostroff is currently serving as acting commissioner of the FDA, following Dr. Margaret Hamburg stepping down in March.
Sorin S.p.A., Milan, Italy, a global medical device company and a leader in the treatment of cardiovascular diseases, and Cyberonics, Inc., Houston, TX, a medical device company with core expertise in neuromodulation, announced the appointment of Vivid Sehgal as Chief Financial Officer of LivaNova PLC, following the proposed merger of the two companies.
IBM’s Watson Health unit, Cambridge, MA, which brings cloud-based services under the IBM Watson Health moniker, has appointed Deborah DiSanzo as General Manager.
The Advanced Medical Technology Association (AdvaMed), Washington, DC,announced that Matthew E. Wetzel has joined the association as Vice President and Assistant General Counsel. AdvaMed will honor Dr. Thomas J. Fogarty, President,Research and Development, at Fogarty Research & Development, Portola Valley, CA, with its 2015 Lifetime Achievement Award. Fogarty is a world-renowned cardiovascular surgeon, entrepreneur, and the inventor of theembolectomy catheter, which influenced the way surgery was performed, and other inventions. The award is designed to honor an individual who through his or her lifetime has greatly contributed to the growth or prominence of the medical technology industry.
The MEDICREA Group, Paris, France, which specializes in the development and manufacturing of innovative surgical technologies to treat spinal pathologies, announced that Gregory Rhinehart has joined the company’s US-based subsidiary, MEDICREA USA Corp., as Vice President of Sales.
Cutting Edge Spine, Waxhaw, NC, which is developing spinal technologies, named J.D. Williams as its National Sales Manager.
Event Cardio Group, Inc., New York, NY, a developer of medical diagnostic detection equipment, has appointed Julie Singleton as Chief Executive Officer of its BreastCare Division and to the company’s Board of Directors.
CONMED Corporation, Utica, NY,which provides surgical devices and equipment for minimally invasive procedures, has appointed Nathan “Nate” Folkert as Vice President and General Manager of its Orthopedics business.
Ortho Kinematics‚ Inc., Austin, TX, a healthcare diagnostics company focused on spine imaging informatics, announced the appointment of Tom Anderson as Vice President of Sales, and Chris White as Vice President of Finance.
Palmaz Scientific, Inc., Fremont, CA, which specializes in the research, development, and commercialization of advanced metallurgical surface nanotechnologies to manufacture implantable medical devices, has appointed Dr. Philippe Henri Marco as President and Chief Executive Officer.
Expansions/Spinoffs/New Services/Moves
Phillips-Medisize Corporation, Hudson, WI, a global leader in outsource design, development, and technology-driven manufacturing, announced the completion of a 5,000 sq. ft. expansion to its Hudson, Wisconsin, Design and Development Center. This new space will be occupied with expanded biopharmaceutical drug delivery and medical device test engineering capabilities including test method development, test method validation, product characterization, design verification testing, and root cause analysis, among others.
Digicom Electronics, Inc., Oakland, CA, which specializes in complex electronic boards and assemblies for medical device, military, aerospace, and industrial products, has expanded its facility in Oakland, doubling in size, and adding more advanced manufacturing equipment and additional personnel.
The University of Adelaide, Australia, has announced its new research and development and manufacturing hub based on a new generation of specialty glass products for the global science and medical equipment market.
Cambridge Technology, Bedford, MA, which designs, develops and manufactures innovative beam steering solutions, announced the grand opening of its first R&D center in China. The company's Suzhou development center focuses on laser beam steering solutions to leading OEM partners in advanced industrial and medical applications.
Mergers/Acquisitions/Collaborations/Licensing
Proto Labs, Maple Plain, MN, the world's fastest digital manufacturing source for custom prototypes and low-volume production parts, has reached an agreement in principle to acquire select operations of Alphaform AG, Feldkirchen. Germany, which will significantly expand Proto Labs’ additive manufacturing capabilities in Europe by adding selective laser sintering, direct metal laser sintering, and additional stereolithography capabilities. The purchase also includes injection molding services currently stationed in Eschenlohe, Germany.
Grace Medical, Memphis, TN, which specializes in products for ENT specialists, has acquired Otomed, Lake Havasu City, AZ, a leader in the field of Otorhinolaryngology.
Coaxial Components Corp., Stuart, FL,whichdesigns and manufactures an extensive line of standard, as well as custom microwave and RF connectors, has entered into a strategic agreement with Ultram Technologies Ltd., Moshav Mazor, Israel, which specializes in components, systems, SatCom, test and measurement equipment, and general electronic instruments, making them Coaxicom’s exclusive representative for Israel.
Nipro Corporation, Osaka, Japan, a maker of circulatory devices, has agreed to acquire Infraredx, Inc., Burlington, MA, an intravascular imaging company focused on the diagnosis and management of coronary artery disease globally.
Physio-Control, Inc., Redmond, WA, a leading provider of professional emergency medical response solutions, has reached an agreement to acquire HeartSine Technologies, Belfast, Northern Ireland, an automated external defibrillator manufacturer.
Cantel Medical Corp., Little Falls, NJ, a leading global company dedicated to delivering innovative infection prevention and control products and services, has acquired Medical Innovations Group Holdings Ltd., Essex, UK, a leading provider of endoscope storage and transport systems in the UK and internationally.
Saki Corporation, Tokyo, Japan, an innovator in the field of automated optical inspection equipment, announces that Saki America, Fremont, CA, has added three new distributors: SMT Equipment, Bench Top Solutions, and Contek Sales & Marketing. The companies will provide sales support for Saki’s 2D and true 3D automated optical, solder paste, and x-ray inspection systems.
Qualcomm Inc., a world leader in 3G, 4G and next-generation wireless technologies, announced that its subsidiary,Qualcomm Life, Inc., San Diego, CA, which is focused on device connectivity and data management for medical device manufacturers, has acquiredCapsule Tech, Inc.,Andover, MA, a leading global provider of medical device integration and clinical data management solutions.
OMRON Corporation, Kyoto, Japan, a global leader in the field of automation based on sensing and control, and Adept Technology, Inc., Pleasanton, CA, a global, leading provider of intelligent robots, autonomous mobile robot solutions and services, today announced that the two companies have entered into an agreement whereby OMRON will acquire Adept.
ZOLL Medical Corporation, Chelmsford, MA, an Asahi Kasei Group company that manufactures medical devices and related software solutions, announced that it has acquired Kyma Medical Technologies, Ltd., Tel Aviv, Israel, which develops technologies to measure early signs of congestive heart failure.
Sparta Systems, Inc., Hamilton, NJ, a global leader in enterprise quality management software solutions, announced the addition of Infinity, a Stamford Technology Solutions Company, developing intellectual properties in the niche domain of drug safety, enterprise quality management, regulatory/compliance, and lean value chain optimization, to its partner network.
TransEnterix, Inc., Research Triangle Park, NC, which is pioneering the use of robotics to improve minimally invasive surgery, has acquired the surgical robotics division of SOFAR S.p.A., Milan, Italy, which has developed an advanced robotic system for minimally invasive surgery, which has an active CE Mark.
Miscellaneous
COMSOL, Inc., Burlington, MA, the leading provider of multiphysics modeling and simulation software, announces new Focus Sessions and Training Sessions to be featured at the 11th Annual COMSOL Conference, the world’s largest event for multiphysics simulation and application design, taking place October 7 to 9 in Boston, MA. Focus sessions will include: Best Practices in Acoustics Simulation, Best Practices in Heat Transfer and Phase Change Simulation, and Best Practices in Electromagnetic Simulations. More than 30 application-specific training sessions will be held. For more information, visit www.comsol.com/conference2015/boston .
Advanced Cooling Technologies, Inc., Lancaster, PA, which specializes in advanced thermal technology development and custom thermal product manufacturing, has been named a Best Place to Work in PA for 2015, for the third year in a row. The awards program is a partnership between Team Pennsylvania Foundation, the Pennsylvania Department of Community and Economic Development, the Pennsylvania State Council of the Society for Human Resource Management, and the Central Penn Business Journal.
The Executive Board of the Coordinate Metrology Society (CMS), the eminent membership association for measurement professionals, announced a name change for its Coordinate Metrology Systems Conference (CMSC). The new name of the event is the Coordinate Metrology Society Conference.
Tech-Etch, Inc., Plymouth, MA, a leading manufacturer of precision components for industry, has completely recoded its website with more than 160 pages to offer easy viewing and navigation on desktop, tablet, and even smartphone browsers. Mobile users can interact with content in three product areas: photo etched precision parts, EMI/RFI shielding, and flexible printed circuits. See: www.tech-etch.com .
Pepperl+Fuchs, Twinsburg, OH, a world leader in the design, manufacture, and application of high quality factory and process automation products and services, announced that online ordering is now available for 2,000+ commonly stocked items including: sensors, intrinsic safety barriers, and select accessories for purge and pressurization systems, and for a limited time the company is offering free UPS Ground shipping for online orders. Orders can be placed 24/7 at www.pepperl-fuchs.us .
Netech Corporation, Farmingdale, NY, a leading Industrial test instrument manufacturer, has just posted its new online ecommerce site, www.pressuremeter.com . The new site offers customers a quick way to purchase Netech instruments and receive services.
