Here is the latest batch of news from the medical products community. Please click the link for more.
Regulatory Approvals and Launches
Given Imaging Ltd. , Yoqneam, Israel, announced that it has received FDA approval of its PillCam COLON 2 as a new modality to provide visualization of the colonto detect colon polyps in patients after an
Ziehm Imaging, Orlando, FL, a world leader in C-arm interventional imaging, announced FDA clearance to market its new generation Ziehm Vision RFD C-arm for pediatric and other interventional operating room procedures in the US.
Claret Medical, Santa Rosa, CA, has been granted an investigational device exemption for its Sentinel cerebral protection system, allowing clinical trials to commence. The device is intended to prevent embolisms during transcatheter aortic valve replacement.
Boston Scientific, Natick, MA, announced the US launch and first use of its OffRoad Re-Entry Catheter System, which aids physicians perform stenting or angioplasty in patients with advanced peripheral artery disease.
Connecticut Spring & Stamping, Farmington, CT, a manufacturer of precision parts worldwide, has been certified to the ISO 13485 standard for quality management for design and manufacturing of medical devices.
Polymicro Technologies™, Lisle, IL, a subsidiary of Molex Incorporated, announced its recent registration and compliance with FDA 21 CFR 820 Quality System Regulation. Polymicro manufactures silica capillary tubing, specialty optical fibers, optical and capillary assemblies, and discrete micro components.
Teleflex Incorporated, Limerick, PA, a leading global provider of medical devices for critical care and surgery, announced the launch of the Rusch® DispoLED™ Single-Use Fiber Optic Laryngoscope Handle to combat cross-contamination infection risk during intubation.
Qosina Corporation, Edgewood, NY, is proud to announced that its ISO 9001 Quality and ISO 14001 Environmental Management Systems have again been recertified for the next three years.
JustRight Surgical, Boulder, CO, a micro-laparoscopic medical device company devoted to miniaturizing surgical instrumentation, has received FDA 510 (k) clearance for its JustRight™ 5mm Stapler, to be used by surgeons in pediatric and general surgery where access is limited.
Smith & Nephew, London, UK, announced the launch of its Polarstem cementless stem for total hip replacement in the US.
Cordis Corporation, Fremont, CA, has received the CE Mark for its RENLANE™ Renal Denervation System to treat patients with resistant hypertension. The company has completed the first successful cases in Europe.
Orfit Industries America, Jericho, NY, North American subsidiary of Orfit Industries, a world leader in the development, and manufacture of thermoplastic splinting materials, has launched Orficast™, a new , self-adhesive thermoplastic for simple splints.
Leadership News
Proto Labs, Inc., Maple Plain, MN, a leading online and technology-enabled quick-turn manufacturer, announced the appointment of Victoria M. Holt as President and Chief Executive Officer.
Milacron LLC, Cincinnati, OH, announced that Bruce Catoen has been named the company’s CTO, and will establish and help execute a three-year product technology roadmap to establish Milacron as the leader in high-precision plastic processing technologies and control systems.
FANUC America Corporation, Rochester Hills, MI, announced that Liz Kautzmann, its Laser/Fabrication Program Manager, has been awarded a 2014 Women in Manufacturing STEP Award from the Manufacturing Institute.
NewAge® Industries, Southampton, PA, which manufactures plastic and rubber tubing, announced the appointment of Michael L. Yakes as its Midwest Regional Sales Manager.
Mack Molding, Arlington, VT, has added several staff members recently. They include: Ted Beyer, medical supply chain manager, and Adam Brooks and Marguerite Farahmand, assupplier engineers in the Procurement Department. Chris Winskowicz and Seth Yellin were hired as manufacturing engineers. John Baker, is aprogram manager within the orthopedics & medical disposables business unit, and Jackie Garrison joined as a sales service representative within the commercial business unit. Christopher Anderson was also hired as a quality engineer.
MC Machinery Systems Inc., Wood Dale, IL, has appointed Alan Hallmann to the position of National Sales Manager–Milling/Turning.
Expansions/Moves
SMC Ltd., Somerset, WI, a medical device contract manufacturer, announced the move of its Costa Rica facility to a new site within the Coyol Business park in Alajuela, Costa Rica, which allowed it to double its manufacturing space.
Insulet Corporation, Bedford, MA, is moving its headquarters to a bigger, 90,000-square-foot space in Billerica as it ramps up for the demand expected for its new, smaller insulin pump.
Tech Group Europe, Dublin, Ireland, a subsidiary of West Pharmaceutical Services, Exton, PA, is set to expand its operation in Dublin by 12,000 square feet to manufacture, assemble and decorate a complex injectable device for the diabetes market, and plans to go into full-scale production next year.
Aerotech Inc., Pittsburgh, PA, a high-technology mechatronic motion products designer and manufacturer, has relocated its UK subsidiary to a new and larger facility in Ramsdell near Tadley to build upon its position as a premier motion system supplier to the UK and Europe.
Mack Molding, Arlington, VT, a leading custom plastics molder and supplier of contract manufacturing services, has doubled the footprint of its Machining Center in Arlington after experiencing a 12‐fold increase in machining sales. The company has added 30% more lathe capacity for its Swiss‐type turning centers, and added a Haas Super Mini Mill with full vertical machining center capabilities to augment its plastics machining capacity.
Fine Tubes Ltd., a global supplier of precision tubes for critical applications, has relocated its sales office in India to a larger location in Noida due to growing demand for tubing products.
Mergers/Acquisitions/Collaborations
PBM Capital Group, a private investment firm, has acquired Breas Medical AB, Mölnlycke, Sweden, from GE Healthcare, a subsidiary of General Electric Company. Breas is a leading manufacturer of home respiratory ventilators and sleep apnea products. PBM Capital will integrate Breas into Human Design Medical, an existing portfolio company.
Milacron LLC, Cincinnati, OH, recently completed the acquisition of Industrial Machine Sales, Inc. (IMSI) and its sister company, Precise Plastics Machinery (PPM), both in Southlake, TX, as well as Kortec, Rowley, MA, a leading supplier of co-injection technology solutions to the packaging industry. IMSI specializes in the application engineering of primary plastics processing and support. PPM was established as a full service support company for the plastics industry.
Olympus, Center Valley, PA, a global technology leader in imaging solutions, has become a Research Partner with École de Technologie Supérieure (ÉTS), part of the Université du Québec network. The partnership will provide ÉTS with new and innovative metrology and microscopy analysis solutions.
GSI Group Inc., Bedford, MA, a global supplier of precision photonics and motion control components and subsystems, has reached an agreement to acquire JADAK Technologies Inc. and JADAK LLC, North Syracuse, NY, providers of optical data collection and machine vision technologies to OEM medical device manufacturers.
MRI Interventions, Inc., Irvine, CA, and Siemens Healthcare, Hoffman Estates, IL, announced an agreement to co-develop and commercialize a next generation software platform that will enable minimally invasive catheter-based procedures to be performed under real-time magnetic resonance imaging (MRI) guidance.
Samsung Electronics Co., Ltd., and the University of California, San Francisco announced a partnership to accelerate validation and commercialization of promising new sensors, algorithms, and digital health technologies for preventive health solutions.
LDRA, Merseyside, UK, a leader in standards compliance, automated software verification, source code analysis, and test tools, has partnered with Xilinx, Inc., San Jose, CA, a leading provider of All Programmable FPGAs, SoCs, and 3D ICs, to streamline standards compliance for safety-critical application development.
Miscellaneous
J-Pac Medical (formerly J-PAC), Somersworth, NH, a provider of innovative, high quality, market-ready solutions, customized to meet the needs of medical device, diagnostic, and life sciences customers, announced the launch of its new website, www.j-pacmedical.com , and the creation of the new J-Pac Medical Innovation Services Group.
Phillips-Medisize Corporation, Hudson, WI, is marking its 50th year of continuous operation and ongoing involvement in the medical and specialty commercial markets.
Valtronic, Solon, OH, announced that its active implant advancement of using glass encapsulation implant technology developed by mb-microtec ag was selected the winner of the Golden Mousetrap Award for Materials and Assembly. The awards recognize companies with innovation in the development of new products in automation, electronics, materials, and design tools.
Tegra Medical, Franklin, MA, announces its new Medical Quick Wire and Tubing estore. As long as customers click or call by 1:00 PM EST, Tegra Medical will ship the wire and tubing requested overnight from its one million feet of in-stock products. See http://store.tegramedical.com .
Aries Electronics, Bristol, PA, a manufacturer of standard, programmed, and custom interconnection products and test sockets, has signed Eastern Instrumentation, Philadelphia, PA, as its representative for the territory that includes Eastern PA, NJ, DE, and Long Island, NY.
Lutronic Corporation, Fremont, CA, an innovator in advanced aesthetic and medical laser technology, has donated its Dual-pulsed Q-switched Nd:YAG SPECTRA™ laser to the Nguyen Tri Phuong Hospital in Vietnam to treat children suffering from disfiguring pigmented lesions.
