Here is the latest batch of news from the medical products community. Please click the link for more.
Regulatory Approvals, Launches, New Technology
St. Jude Medical, Inc., St. Paul, MN, a global medical device company, announced FDA approval for its Allure Quadra™Cardiac Resynchronization Therapy Pacemaker, as well as its Assurity™ andEndurity™pacemakerfamilies of devices. In addition, the company announced the global launch of its Optisure™ Defibrillation Lead. The lead is compatible with all of the company’s implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators.
The FDA has approved the first implantable device for people 18 and older with severe or profound sensorineural hearing loss of high-frequency sounds in both ears, but who can still hear low-frequency sounds with or without a hearing aid. The Nucleus Hybrid L24 Cochlear Implant System is manufactured by Cochlear Ltd., headquartered in New South Wales, Australia.
Proto Labs, Maple Plain, MN, announced that their liquid silicone rubber (LSR) injection molding process is now available through their Protomold Injection Molding Service. With this offering, the company brings a practical and cost-effective way to get real LSR parts really fast.
Equipmed, Sydney, Australia, a leading international developer of cosmetic equipment, has launched the ELux810 aesthetic laser, capable of virtually painless laser hair removal.
IPC’s Validation Services Program, Bannockburn, IL, has awarded the first IPC J-STD-001/IPC-A-610 Qualified Manufacturers Listing (QML) to two IEC Electronics Corporation facilities: Newark, NY, and Albuquerque, NM. In addition, IEC Electronics’ testing laboratory, Dynamic Research and Testing Laboratories in Albuquerque has been certified as an IPC-approved Validation Services Test Laboratory.
Toolcraft, Georgensgmünd, Germany, has been certified as meeting the standard of EN ISO 13485:2012 + AC:2012, which attests to an extensive quality management system for manufacturing surgical tools according to customer specification.
NDS Surgical Imaging, San Jose, CA, has received FDA 510(k) clearance for its new Dome S6c diagnostic display, a six-megapixel LED widescreen model, and the latest addition to the S-series product family.
Medigus Ltd., Omer, Israel, developing minimally invasive endosurgical tools and procedures, announced that the FDA has granted 510(k) clearance for its next generation MUSETM system, which enables an incisionless procedure in patients with symptomatic chronic gastroesophageal reflux disease.
Northwire, Inc., Osceola, WI, a cable engineering company, has added a next generation of verification tools and anti-counterfeit technology to protect customers against the counterfeit wire industry.
Norman Noble, Inc., Highland Heights, OH, a medical device contract manufacturer, announced Noble S.T.E.A.L.T.H. (System To Enable Ablation Laser Technology Haz-Free), an exclusive, athermal laser machining process that makes it possible to produce next-generation bioabsorbable scaffolds and Nitinol-based micro implant designs that could not previously be manufactured using current technologies.
XVIVO Perfusion AB, Gothenburg, Sweden, has received a CE Mark for its newly developed appliance for lung perfusion, the XPS™ Perfusion System.
TEGAM, Inc., Geneva, OH, a leading supplier of innovative RF power measurements, was recently awarded Patent No. 8,558,556, “Planar-axial thermistor for bolometry,” for a novel way to construct very small planar thermistors on a substrate with very low heat transfer.
Shimadzu Medical Systems USA, Torrance, CA, has received FDA 510(k) clearance to market its Trinias family of digital angiography systems, which include a ceiling-mounted, flour-mounted, and biplane model.
Rotation Medical, Inc., Plymouth, MN, a medical device company focused on developing new technologies to treat rotator cuff disease, has received FDA 510(k) clearance for its implantable collagen scaffold technology.
OxySure, Frisco, TX, announced that its Model 615 over-the-counter portable oxygen device has been granted CE Mark approval.
Spiracur Inc., Sunnyvale, CA, announced that it has received FDA 510(k) clearance for its
IlluminOss Medical, East Providence, RI, a commercial stage medical device company pioneering the development of minimally invasive fracture fixation technologies, has received a Notice of Allowance from the U.S. Patent and Trademark Office for instruments used in the company's proprietary Photodynamic Bone Stabilization System.
TRUMPF Inc., Farmington, CT, was awarded reaccreditation status from the The International Association for Continuing Education and Training (IACET). TRUMPF’s education programs train more than two thousand customers each year in machine operation, maintenance, programming, and other important technical skills.
Leadership News
Tegra Medical, Franklin, MA, which provides precision machining and contract manufacturing services for the medical device industry, announced that Lee Crowe has joined the company as Vice President of Sales and Marketing.
Nordson ASYMTEK, Carlsbad, CA, announced that Alec Babiarz, President, Business Development and Co-founder of ASYMTEK, is retiring. He, along with two fellow engineers, established Nordson ASYMTEK (originally Asymtek) in 1983 in Vista, CA, with a simple x-y platform and a z-axis head and invented what is now called “benchtop automation,” creating the first precise benchtop automated fluid dispensing system.
IPC – Association Connecting Electronics Industries® , Bannockburn, IL, announced that Tom Sandman has joined the IPC staff as Chief Financial Officer, responsible for leading global financial operations.
Nevro, Menlo Park, CA, a growth stage medical device company focused on developing innovative, evidence-based solutions in neuromodulation, announced the appointment of David Caraway as its Chief Medical Officer.
The Advanced Medical Technology Association (AdvaMed), Washngton, DC, has announced that José "Joe" E. Almeida, Chairman, President and CEO of Covidien, has been named chairman of the AdvaMed Board of Directors for a two-year term. As chairman, he will focus on strategic initiatives to ensure the US maintains its global competitiveness in medical innovation.
Caliber Imaging & Diagnostics, Rochester, NY, formerly Lucid, Inc., has appointed Joseph R. Williams as its first Vice President of Global Marketing, effective immediately.
Fine Tubes, Plymouth, UK, a manufacturer and global supplier of precision tubes for the most demanding applications, announced the appointment of Phil Adderley as Technical and Quality Director. He will have overall responsibility for Quality Assurance and Compliance, Quality Control, Technical, and Laboratory Services.
Expansions/Moves
Crouzet Motors, Vista, CA, celebrates the inauguration of its new 49,514 square foot facility, appropriately named, Global Center of Motor Technology in Ales, France, with a brief video on the company's core strengths and capabilities. See the video .
Mergers/Acquisitions/Collaborations/Spinoffs
Baxter International Inc., Deerfield, IL, announced plans to create two separate, independent global healthcare companies -- one focused on developing and marketing innovative biopharmaceuticals and the other on life-saving medical products. Both will be global leaders in their respective markets. The medical products company will retain the Baxter International name. The biopharmaceuticals company will be named at a later date.
Steris Corporation, Mentor, OH, which offers customized infection prevention and contamination control solutions, has agreed to acquire Integrated Medical Systems International, Birmingham, AL, a sterile processing consulting, surgical instrument management and endoscope repair company. IMS will become part of the Steris’ endoscope and surgical instrument repair specialty services business.
3D Systems, Rock Hill, SC,a leading provider of 3D printing centric design-to-manufacturing solutions, has acquired Medical Modeling Inc., Golden, CO, a provider of personalized surgical treatments and patient specific medical devices, including virtual surgical planning and clinical transfer tools, using 3D modeling and printing.
Magnet Applications, a subsidiary of Bunting® Magnetics Co., Newton, KS, has partnered with Magnequench, the magnetic business unit of Molycorp Inc., Greenwood Village, CO, and currently the only legal manufacturer and source of Neo Powders™ used in bonded neodymium magnets in North America.
FATHOM, Oakland, CA, an advanced technology driven company with an expertise in 3D printing and additive manufacturing, announced that the company has entered into a technology development partnership with Lawrence Livermore National Laboratory to introduce and commercialize new market-leading additive manufacturing technologies.
ICON plc, Dublin, Ireland,a global provider of outsourced development services, has agreed to acquireAptiv Solutions , Reston, VA, a leader in the design and execution of adaptive clinical trials .
North Coast Medical, Inc
Aries Electronics, Bristol PA, a manufacturer of standard, programmed, and custom interconnection products and test sockets used worldwide, has signed EOX Sales, Moorestown, NJ, as its representative for the territory that includes the states of Maryland, Virginia, North and South Carolina, Tennessee, Georgia, Mississippi, Alabama, and Florida.
Advantech Co., Ltd., Irvine, CA, announced that it is partnering with the Linear Technology Dust Networks product group, Milpitas, CA, to develop Smart City and Internet of Things (IoT) solutions based on Dust’s SmartMesh IP™ embedded wireless sensor networks. Advantech will develop, manufacture, and sell a variety of IoT gateways, wireless sensors, and solutions that incorporate Linear’s SmartMesh IP embedded products.
Noxilizer, Inc., Baltimore, MD, which is advancing a room temperature, NO2-based sterilization process for life science manufacturers, and Weiler Engineering, Inc., Elgin, IL, a leader in the global Blow/Fill/Seal equipment market, announced an exclusive supply agreement. Noxilizer will provide the NOX FLEXTM Rapid Biodecontamination units for new Weiler ASEP-TECH® Blow/Fill/Seal systems.
Miscellaneous
SPI: The Plastics Industry Trade Association is accepting presentation and speaker proposals for the Business of Plastics Conference, an educational program on advanced technologies and pressing business issues that will take place during the NPE2015 international plastics exposition. Proposals must be posted at www.npe.org/call-papers by May 1, 2014.
Robert J. Dowding, Research Manager for Materials and Manufacturing Science, U.S. Army Research Laboratory, has been selected to receive the first-ever Vanguard Award from the Metal Powder Industries Federation. The award recognizes powder metallurgy (PM) industry champions from the end-user community whose long-time promotion of the technology has contributed to the expansion of powder metal applications. The award presentation will take place at the PM2014 World Congress, May 18–22, in Orlando, Florida.
Pulse Electronics Corporation, San Diego, CA, a leading provider of electronic components, announces the publication of a new test report demonstrating the reliability and longevity of its Sidewinder® AC current sensing technology. The report demonstrates that Sidewinder-based products achieve at least 99.7% reliability after 20 years of 24/7 service and have an estimated mean time to failure of 6,090 years with 90% confidence.
Gems Sensors & Controls, Plainville, CT, has released a new White Paper entitled, “Simplifying the Search for the Perfect Fluid Sensor”, now available for immediate download at www.GemsSensors.com .
Mobius Imaging, LLC, Ayer, MA, has received the internationally recognized Red Dot: Product Design 2014 Award for its Airo® Mobile Intraoperative CT, a one-of-a-kind imaging system, which is distributed under an exclusive sales agreement with Brainlab, Munich, Germany.
Camstar Systems, Inc., Charlotte, NC, will launch its third year of Global Workshops and Plant Tours on April 2, 2014 at Advanced Bionics in Valencia, CA. Host Advanced Bionics, a global leader in cochlear implant innovations and manufacturer of Class III medical devices, will lead round table discussions with manufacturers and industry leaders. For more information, visit www.camstar.com .
Matrox Imaging, Montreal, Quebec, Canada, announced immediate availability of complete native support for the USB3 Vision™ camera interface standard in the Matrox Imaging Library. This lets users take advantage of USB3 Vision cameras on Windows® 7 and 8 imaging systems and increases the selection of camera interface standards that can be employed practically interchangeably. See www.matroximaging.com .
MC Machinery Systems Inc., Wood Dale, IL, a supplier of metalworking—from simple fabrication to CNC-driven, automated manufacturing cells, launched a new website, designed to be more accessible on mobile devices while increasing functionality. See www.mcmachinery.com .
IPC – Association Connecting Electronics Industries, Bannockburn, IL, bestowed its highest corporate honors to STI Electronics, Inc., Madison, AL, and Raytheon Company, Waltham, MA. The IPC Stan Plzak Corporate Recognition Award was presented to STI Electronics and the IPC Peter Sarmanian Corporate Recognition Award to Raytheon Company.
KNF Neuberger, Trenton, NJ, announces the launch of its fully-redesigned website at www.KNFusa.com . Customers can easily review OEM, laboratory, and process pumps and systems content, as well as download detailed product information and supporting data sheets.
Carestream, Rochester, NY, has introduced a new NDT 40-hour training program designed specifically to meet the expanding needs of the Non-Destructive Testing industry. More than 100 years of imaging excellence across the globe is the foundation for its training course, which covers all about the science of digital imaging. See www.carestream.com .
Siemens Hearing Instruments, Inc., Malvern, PA, announced that it will donate $1 million worth of hearing aids through CancerCare’s network of hospitals and the Pediatric Brain Tumor Foundation to benefit patients with permanent hearing loss due to the side-effects of cancer treatment regimens.
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.
Specialty optical fiber and assembly expert Fiberguide Industries, Stirling, NJ, has been chosen to supply medical use optical fibers to National Vein Technologies, Tampa, FL, a provider of vein surgical supplies.
Agilent Technologies Inc., Santa Clara, CA, revealed the new name of its spinoff test and measurement business, which will be known as Keysight Technologies, Inc.
