Here is the latest batch of news from the medical products community. Please click the link for more.
Regulatory Approvals, Standards, and Launches
Edwards Lifesciences Corporation, Irvine, CA, a global leader in heart valves and hemodynamic monitoring, announced that it has received FDA approval of the Edwards SAPIEN 3 valve with the Commander Delivery System, its most advanced transcatheter aortic heart valve, used to treat high-risk patients suffering from severe, symptomatic aortic stenosis.
LEMO USA, Inc., Rohnert Park, CA, a subsidiary of LEMO SA, Ecublens, Switzerland, a global leader in the design and manufacture of precision custom connection solutions, has achieved ISO 13485 Certification for the design, manufacture, and distribution of medical components and cable assembly to medical customers. These certifications are accredited by SQS, Swiss Association for Quality and Management in partnership with IQNet.
Stimwave Technologies Incorporated, Miami, FL, a medical device manufacturer and independent research institute, has received an FDA Investigational Device Exemption approval to launch a clinical trial utilizing the world’s first and only wireless miniature eight electrode, multi-programmable neurostimulator device to treat chronic back and leg pain.
SurgiQuest, Inc., Milford, CT, a leading provider of innovative access technologies for minimally invasive surgery, announced that its AirSeal® System recently received FDA 510(k) clearance for Transanal Endoscopic Surgery.
ALung Technologies, Inc., Pittsburgh, PA, a developer and manufacturer of innovative lung assist devices, has received CE Mark approval for its next generation Hemolung XG4 Cartridge and Catheter Kits.
Caplugs, Buffalo, NY, a global manufacturer of plastic protective closures serving 25 of the top 30 medical device companies, announced that its Class 8 clean room is ISO 9001 certified and recently received ISO 13485 recommendation.
Wicab, Inc., Middleton, WI, has received FDA de novo approval for its assistive device BrainPort V100, which can help blind people process visual images with their tongues.
Medtronic plc, Dublin, Ireland, a global leader in medical technology, announced the FDA approval and US launch of its self-expanding CoreValve Evolut R System, the first-and-only recapturable and repositionable device in the US for transcatheter aortic valve replacement in severe aortic stenosis patients at high risk for surgery.
Torax Medical, Inc., St. Paul, MN, which develops and markets products designed to treat sphincter disorders, announced that the FDA has approved a next-generation LINX Reflux Management System that is MR conditional in magnetic resonance imaging systems up to 1.5 Tesla.
Advanced Cooling Therapy, Chicago, IL, announced that its first product, the Esophageal Cooling Device, has secured FDA de novo clearance. The product’s technology platform provides a novel method to control patient temperature using the esophagus.
Express Logic, Inc., San Diego, CA, a worldwide leader in royalty-free real-time operating systems, announced that its popular ThreadX® RTOS is compliant with all required and mandatory rules of MISRA C:2004 and MISRA-C:2012.
Leadership News
TRUMPF Inc., Farmington CT, announced that Annette Doyle will take on the role of Managing Director of TRUMPF Limited, Luton, Bedfordshire, UK, the UK subsidiary of the TRUMPF Group. She had been Assembly Manager at TRUMPF Inc.
Cook Group, Bloomington, IN, announced that Kem Hawkins, President of Cook Group Incorporated, will retire on July 1 after 34 years with the Cook organization. Hawkins will remain on the Board of Directors for Cook Group. Pete Yonkman, current President of Cook Medical, has been chosen as Hawkins’ successor as President of Cook Group.
Zeidman Consulting, Cupertino, CA, an R&D contract firm specializing in digital hardware and software design and software forensics, announced that founder and president Bob Zeidman was recognized by the Santa Clara Valley Section of the Institute of Electrical and Electronics Engineers (IEEE) with its Outstanding Engineer Award for his pioneering contributions to the field of software forensics.
SL Power Electronics, Ventura, CA, a division of SL Industries and an industry leader in the design and manufacture of rugged, highly reliable power supplies, has appointed Karim Alhusseini to the position of Vice President of Sales and Marketing.
Nihon Kohden, Tokyo, Japan, a leading manufacturer, developer, and distributor of medical electronic equipment, announced that Senior Manager Dr. Takuo Aoyagi has received the 2015 Institute of Electrical and Electronics Engineers Medal for Innovations in Healthcare Technology or his pioneering contributions topulse oximetry.
TissueGen® Inc., Dallas, TX, a leader in extrusion of biodegradable polymer fibers for drug delivery, announced that Jennifer Seifert, PhD, has joined the company in the newly established role of Senior Scientist.
EndoGastric Solutions, Redmond, WA, a leader in incisionless procedural therapy for gastroesophageal reflux disease, announced three new appointments to its executive team: Mike Zagger as Vice President, Sales and Marketing; Philip Macdonald as Vice President of Healthcare Economics, Policy & Reimbursement; and Adrian Lobontiu, MD, FACS - Medical Director.
Expansions/Spinoffs/New Services/Moves
MedVenture Technology Corporation, Jeffersonville, IN, a medical device design and manufacturing company of minimally invasive surgical and catheter-based devices and a part of Helix Medical, announces plans to expand its product design and development operations in southern California, and expects to launch operations there during the third quarter of 2015.
GW Plastics, Bethel, VT, an injection molder offering in-house mold design-and-build on an international scale, has expanded in-house Liquid Silicone Rubber tooling at its affiliate, GW Silicones, Royalton, VT.
Abiomed, Inc., Danvers, MA, a leading provider of medical devices that provide circulatory support, plans to lease an additional 85,000 square feet of space in a building next to its headquarters, and to add 100 employees over the next two years.
ATP, Wollerau, Switzerland, an international, innovative and independent group of companies which specialises in the development, production and sale of technical adhesive tape systems,opened its latest state-of-the-art production plant for water-based adhesive coatings in Mihla, Germany.
Berliner Glas Group Coating & Surfaces Division develops and produces coatings for the telecommunications and medical technology industries. It has recently expanded and moved to new premises in Berlin-Britz, Germany, adding new clean rooms and a complete redesign.
Idneo, Barcelona, Spain, which provides engineering services worldwide to the sectors of mobility, medical, consumer electronics and industrial equipment, plans to strengthen its international presence by opening offices in the United States and Germany by 2016.
Mergers/Acquisitions/Collaborations/Licensing
Proven Process Medical Devices Inc., Mansfield, MA, a global leader in the design, development, validation, and manufactureof Class II and Class III medical devices, announced that it has entered into a development agreement with PathMaker Neurosystems Inc., Boston, MA, which is focused on neuromodulation, to develop and manufacture a first-in-class non-invasive device for treating patients with muscle tone disorders using trans-spinal direct current stimulation technology.
Eastman Chemical Company, Kingsport, TN, a global specialty chemical company, and Prestige Mold Incorporated, Rancho Cucamonga, CA,a manufacturing leader of the high-quality precision injection molds, have collaborated to create a first-of-its-kind multi-cavity, hot runner mold for producing intricate medical parts. The two companies proactively created the 32-cavity mold specifically for Eastman Tritan™ copolyester to address future customer needs for durable medical device parts free of bisphenols A and S.
LDRA, Wirral, UK, a leader in standards compliance, automated software verification, source code analysis, and test tools, continues to build on its relationship with Wind River, Alameda, CA, a pioneer in embedded software . In addition to the full integration of the LDRA tool suite with Wind River VxWorks 7 real-time operating system, LDRA tools and product information are now featured and available for download in the Wind River Marketplace .
BD Medical, Franklin Lakes, NJ, which develops, manufactures and sells medical devices, instrument systems and reagents, and Medtronic plc, Dublin, Ireland, a global leader in medical technology, announced a collaboration to introduce a new insulin pump infusion set with BD FlowSmart™ technology. Medtronic will commercialize the infusion set, while BD will manufacture the product.
Hill-Rom, Inc., Batesville, IN, a medical equipment manufacturer, has announced it will acquire Welch Allyn, Skaneateles Falls, NY, a manufacturer of diagnostic and patient-monitoring equipment. Hill-Rom also says it is moving its headquarters to Chicago.
A new license agreement with Gelest, Inc., Morrisville, PA, a manufacturer and supplier of organosilicon compounds, metal-organic compounds, and silicones, gives King Plastic Corporation, North Port, FL, a leading manufacturer of polymer sheets, slabs, and shapes, exclusive use of Biosafe® antimicrobial additive in polyolefin sheet stock, enabling the company to offer products that retain antimicrobial effectiveness even after fabrication.
Express Logic, Inc., San Diego, CA, a worldwide leader in royalty-free real-time operating systems, announced that Renesas Electronics, a premier supplier of advanced semiconductor solutions, has selected Express Logic’s X-Ware™ exclusively as the cornerstone software solution for its new Renesas Synergy™ Software Package.
Richardson Electronics, Ltd., LaFox, IL, a leading global provider of engineered solutions, displays, detector solutions and parts for diagnostic imaging equipment, signed a definitive agreement to acquire the assets of International Medical Equipment and Service, Inc., Fort Mill, SC, which offers solutions for the diagnostic imaging equipment lifecycle.
Ottobock, Duderstadt, Germany, and Austin, TX, a global leader in prosthetics, and UNYQ, San Francisco, CA, a pioneer in customized prosthetic design, announced a strategic partnership to provide stylish cosmetic coverings for lower limb prostheses.
Novelda AS, Oslo, Norway, a developer and manufacturer of adaptive smart sensors, has appointed Harper and Two, Signal Hill, CA,as its Southwest US sales representative covering southern CA, AZ, NM, and Clark County, NV.
Medtronic plc, Dublin, Ireland, a global leader in medical technology, recently acquired Aptus Endosystems, Sunnyvale, CA, which specializes in aortic aneurysm repair technology. Last week, Medtronic announced that it had acquired CardioInsight Technologies, Cleveland, OH, which will become part of Medtronic’s Atrial Fibrillation Solutions business.
Insulectro, Lake Forest, CA, a leading supplier of materials for use in the PCB and printed electronics industries, announced a partnership, beginning in July, to supply throughout North America world-class performance copper foils manufactured by Oak-Mitsui, Hoosick Falls, NY, a technological leader in the manufacture of high-quality electrodeposited copper foils for the printed circuit board industry. In addition, CAC, Inc., Lake Forest, CA, will now manufacture its CAC (Copper-Aluminum-Copper) bonded product with Oak-Mitsui copper Foil. CAC products will continue to be distributed through its global distribution partners, including Insulectro.
SUSS MicroTec, Garching, Germany, a global supplier of equipment and process solutions for the semiconductor industry and related markets, and the Georgia Institute of Technology, Atlanta, announced a collaboration for nanotechnology, bio-medical, and semiconductor 3D packaging research.
MicroE Systems, Bedford, MA, a member of GSI Group, a manufacturer of encoder technologies and positioning systems, has joined with Applimotion, Inc., Loomis, CA, which provides direct drive motor components and assemblies, to create Celera Motion, Bedford, MA, to solve application-specific challenges for medical, advanced industrial, scientific, and microelectronics equipment manufacturers.
Miscellaneous
Servometer, Cedar Grove, NJ, announces that its new line of precision motion control bellows couplings and rugged beam couplings are now available for purchase through its newly launched e-commerce site www.buy.servometer.com .
Coaxial Components Corp., Stuart, FL, which manufactures RF connectors, attenuators, terminations, adapters, torque wrenches, phase adjusters and cable assemblies, has been nominated for the Florida Companies to Watch Award, presented by GrowFL, in association with the Edward Lowe Foundation.
Intelligrated, Cincinnati, OH, a leading automated material handling solutions provider, announced the rebranding and evolution of its software group. The integration of the Knighted brand is complete, with all software products now falling under the Intelligrated Software brand providing software solutions to optimize complex automated and manual fulfillment operations.
IPC–Association Connecting Electronics Industries, Bannockburn, IL, has released IPC-T-50 Revision M, Terms and Definitions for Interconnecting and Packaging Electronic Circuits. This standard provides common language of terms and definitions for the electronics industry.
G-S PLASTIC OPTICS, Rochester, NY, a leading manufacturer of precision polymer optics for use in LED illumination systems, imaging, scanning, and detection applications worldwide, announced it has launched its new website at http://www.gsoptics.com .
AssurX, Inc., Morgan Hill, CA, an enterprise quality management, risk, and regulatory compliance solution provider, announced the release of the latest update to its AssurX document management software, which is fully compliant for small- to medium-sized companies in FDA-regulated industries. http://www.assurx.com/software-solutions/document-control-management.htm .
MTD Micro Molding, Charlton, MA, a leader in micro molding, as released a new mobile website that can be viewed on any device. Visit www.mtdmicromolding.com .
