Here is the latest batch of news from the medical products community.
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Regulatory Approvals, Standards, and Launches
LDRA, Wirral, UK, a leader in standards compliance, automated software verification, source code analysis and test tools, has secured a patent for TBmanager, its premiere software life cycle traceability and verification system.
Cynosure, Inc., Westford, MA, has received FDA 510(k) clearance for its new 532 nm Laser Delivery System for PicoSure®, a powerful, dual-wavelength laser system to remove tattoos of all colors in fewer treatments.
Bioness, Inc., Valencia, CA, announced that the FDA has cleared its StimRouter®, an implantable neuromodulation device designed to treat chronic, intractable pain of peripheral nerve origin.
Dallen Medical Inc., San Clemente, CA, an innovator in bone fixation and repair, has receive FDA 510(k) clearance for its Tensyn™ Plug, the first adjustable orthopedic fixation device.
Simplify Medical, Inc., Mountainview, CA, received the CE Mark for its Simplify DiscTM, a non-metal, MRI-friendly cervical artificial disc.
Sonoma Orthopedic Products, Buffalo Grove, IL, a medical device manufacturer specializing in minimally-invasive bone fracture repair, has received FDA 510(k) clearance for its intramedullary FibuLock Nail to treat ankle fractures.
Neuronetrix Inc., Louisville, KY, has received FDA 510(k) clearance for its COGNISION™ System, portable device used to record electrical brainwaves from patients with neurological problems.
20/20 Imaging, Garner, NC, a leader in small market imaging, has received FDA approval of its HF PXS-710 digital x-ray system, targeted to the podiatry market.
St. Jude Medical, Inc., St. Paul, MN, a global medical device company, has received FDA approval for its FlexAbility™ Ablation Catheter to treat cardiac arrhythmias.
Leadership News
NewAge Industries, Southampton, Pa, which manufactures plastic and rubber tubing in both reinforced and unreinforced styles, announced the promotions of Mary Marcus to the position of Director of Quality, and Mary Vander Neut to Finance Director.
Toshiba America Medical Systems, Inc., Tustin, CA, which markets, sells, distributes and services radiology and cardiovascular systems, has named Guy Poloni as Director of its MR Business Unit, and Bill Newsom as Director of its X-ray Vascular Business Unit.
Alexandria Industries, Alexandria, MN, which manufactures customized aluminum extrusions, precision machining of ferrous and non-ferrous products, heatsinks, and plastic injection and foam molding components for a wide range of OEMs, announced the addition of Duncan Crowdis to its Board of Directors.
Pamela Kan, Presdient of Bishop-Wisecarver Group, Pittsburg, CA, a leader in custom automation solutions and guiding motion technology, has been selected as one of the Astra Leadership Forum Committee Representatives, a regional partner organization for the Women’s Business Enterprise National Council.
Freedom Innovations, LLC, Irvine, CA, a leader in advanced technology prosthetic devices for lower limb amputees, has added Achilleas Dorotheou and Christa Kreuzburg to its Board of Directors.
Cardiva Medical, Inc., Sunnyvale, CA, a medical device company focused on developing and commercializing innovative vascular closure technology, announced that John Russell has been appointed President, Chief Executive Officer, and member of the company’s Board of Directors.
Expansions/Spinoffs/New Services/Moves
Mack Medical/Mack Molding, Arlington, VT, a leading custom plastics molder and supplier of contract manufacturing services, is investing $2 million to expand its cleanroom molding and assembly capacity to handle its significant growth in the medical disposables market. The company is adding four electric presses. In addition, the company has added David Clatworthy and Timothy Hutchings to its staff to handle manufacturing engineering responsibilities for medical devices.
Diversified Plastics Inc., Minneapolis, MN, a custom injection molder for the medical device market, has installed a 1,300 square foot controlled environment production room inside its manufacturing facility for use in product assembly and packaging operations. The company has also added a Toshiba 310-ton plastic injection molding press to its production facility.
MIDI, Ronkonkoma, NY, a global leader in medical product development, has formed a Medical Center of Excellence, whoich will significantly assist in facilitating MIDI’s rapid growth and presence in the medical/healthcare product development industry. Groundbreaking will commence this Spring.
Freedom Innovations, Irvine, CA, a leader in advanced technology prosthetic devices for lower limb amputees, has expanded its headquarters by constructing a new 3,500 sq. ft. state-of-the-art manufacturing facility for next-generation microprocessor controlled and powered prosthetic ankles and knees. The company will be hiring more than 30 new employees this year.
Victrex plc, Thornton-Cleveleys, UK, a global world leader in high performance polyaryletherketone (PAEK) polymers, is planning to increase its global technology leadership by constructing a major Polymer Innovation Center in northern England. The center will enable the scaling up of new products and applications to full commercialization.
RAUMEDIC, Helmbrechts, Germany, which makes polymer components for the medical industry, plans to build a 60,0000-square-foot plant in Mills River, NC, and hire more than 170 employees.
Mergers/Acquisitions/Collaborations/Licensing
TE Connectivity Ltd., Schaffhausen, Switzerland, and Berwyn, PA, a world leader in connectivity, has entered into a definitive agreement to acquire AdvancedCath, Watertown, MA, which designs, develops, and manufactures advanced catheter systems.
Pro-Dex, Inc., Irvine, CA, which specializes in the design, development, and manufacture of powered rotary drive surgical and dental instruments, has acquired Fineline Molds, San Dimas, CA, which manufactures plastic injection molding tools.
Medtronic plc, Dublin, Ireland, a global leader in medical technology, has acquired Advanced Uro-Solutions, Elizabethton, TN, a developer of neurostimulation products to treat bladder control issues.
GSI Group Inc., Bedford, MA, a global leader and supplier of precision photonics and motion control components and subsystems to the medical equipment and advanced industrial technology markets, has reached an agreement to acquire Applimotion Inc., Loomis, CA, a provider of advanced precision motor and motion control technology to OEMs for advanced industrial and medical markets.
3M, St. Paul, MN, has entered into a definitive agreement to acquire Ivera Medical Corp., San Diego, CA, a manufacturer of health care products that disinfect and protect devices used for access into a patient’s bloodstream. In addition, 3M has entered into a definitive agreement with Polypore International Inc., Charlotte, NC, to acquire the assets and liabilities associated with Polypore’s Separations Media business.
Sagentia Group plc, Cambridge, UK, and Boston, MA, a global technology advisory and product development company, has acquired Oakland Innovation Limited, Cambridge, UK, a technology consultancy specializing in market intelligence for the global consumer and healthcare markets.
Miscellaneous
RTP Company, Winona, MN, announced that its Beaune, France facility is celebrating 20 years of operation. The Beaune facility is ISO certified and features compounding equipment, a state-of-the-art color lab, and shipping facilities to produce and ship custom engineered thermoplastics in more than 60 different resin systems to customers across Europe.
Wilbrecht LEDCO, Inc., St. Paul, MN, a subsidiary of Microprecision Electronics SA, a manufacturer of LED indicator lights, metal foil resistors, and mechanical switches, has become a member of the Electronic Components Industry Association.
BSD Medical Corporation, Salt Lake City, UT, a provider of medical systems that utilize heat therapy to treat cancer, has changed its corporate name to Perseon Corporation.
Mouser Electronics, Inc., Mansfield, TX, a global authorized distributor with the newest semiconductors and electronic components, is partnering with celebrity engineer Grant Imahara to call on engineers of all levels to join them on a journey to Empower Innovation Together™. Engineers worldwide can engage with Grant Imahara through a variety of topics and series of challenges that question and defy innovation in the pursuit of new ideas. To learn more, visit www.mouser.com/empoweringinnovation .
