Here is the latest batch of news from the medical products community. Please click the link for more.
Regulatory Approvals, Standards, and Launches
St. Jude Medical, St. Paul, MN, has received FDA 510(k) clearance for its Protégé MRI spinal cord stimulation system—the smallest MR-conditional SCS implantable pulse generator commercially available in the US.
Teleflex Medical OEM, Gurnee, IL, a global leader in custom sutures and performance fibers, has been granted a patent by the European Patent Office for its high-strength, Force Fiber® suture, which combines a coreless braid design with fibers of ultra-high molecular weight polyethylene.
Monteris Medical, Plymouth, MN, which develops devices for minimally-invasive, MR-guided neurosurgery, announced the launch of two new reduced diameter mini-probes for its NeuroBlate® System, a minimally invasive robotic laser thermotherapy tool.
Sensory NeuroStimulation Inc., San Clemente, CA, a pioneer of non-pharmacological treatments for RLS (Restless Legs Syndrome), announced today that the U.S. Patent and Trademark Office has issued a patent covering the technologies used in RelaxisTM, a vibratory medical device that helps improve the quality of sleep in patients with primary RLS.
Royal Philips, Amsterdam, The Netherlands, announced the European launch of VesselNavigator, its latest innovation in live 3D catheter navigation to guide the minimally invasive treatment of patients with vascular diseases. This new catheter navigation solution, designed for use in conjunction with Philips’ interventional X-ray systems, enhances the accuracy of stent placement, while reducing contrast medium usage. VesselNavigator is awaiting FDA approval.
The Medicrea Group, Lyon, France, which specializes in implants to treat spinal pathologies, today announced the U.S. launch of LigaPASS® 2.0generation, the company's band connector technology for posterior thoraco-lumbar fixation.
Surefire Medical, Inc., Westminster, CO, announced that the company's new Precision targeted delivery infusion system, used for direct-to-tumor embolization procedures, has received the CE Mark.
Butler Automatic, Middleborough, MA, an inventor and global leader of automatic splicing solutions, announces that it has received ISO 9001:2008 Quality Management System certification following a rigorous audit of Butler Automatic’s quality procedures.
Teleflex Incorporated, Wayne, PA, a leading global provider of medical devices for critical care and surgery, announced the promotion of Liam Kelly to the newly created role of Chief Operating Officer, responsible for the global commercial strategy of the company as head of the Americas, Asia Pacific and Europe, Middle East, and Africa regions.
MTD Micro Molding, Charlton, MA, a leader in micro-injection molding, has promoted Operations Manager Gary Hulecki to Executive Vice President.
Lee Spring, Brooklyn, NY, a global manufacturer of mechanical springs and related products, has announced the appointment of Jim Callaghan to a newly created position of Executive Vice President of Business Development.
Intelligrated, Cincinnati, OH, a leading automated material handling solutions provider, has appointed John Sorensen to the position of Senior Vice President and General Manager, Lifecycle Support Services, and appointed Chuck Adams to the position of Senior Vice President and General Manager, Sales.
Thoratec Corporation, Pleasanton, CA, a leader in mechanical circulatory support therapies for failing hearts, announced that Marta Antonucci has joined the company in the newly created role of President, International.
TÜV Rheinland, Cologne, Germany, a full-service inspection, testing and certification company, announced the appointment of Uwe Meyer as Business Field Manager-Medical Test. He will be based at the Irvine, CA office.
Canon U.S.A., Inc., Melville, NY, a leader in digital imaging solutions, announced the appointment of Akiko Tanaka as President and CEO of Canon U.S. Life Sciences, Inc., a wholly owned subsidiary of Canon U.S.A., Inc.
ConvaTec Inc., Luxembourg, a global medical products and technologies company, has named its interim CEO, Paul Moraviec, as its new permanent CEO.
Globus Medical, Audubon, PA, a leading musculoskeletal implant manufacturer, has named Daniel Scavilla to be its new CFO.
Phillips-Medisize Corporation, Hudson, WI, a global-leader of outsource design, development, and manufacturing services to the medical device industry, announced the appointment of Winston Brown to the newly created position of Vice President, Global Quality.
Bunting Magnetics Co., Newton, KS, a producer of precision magnetic products for a wide range of industries, has named Harrison Rogers as Southern Territory Manager for Bunting standard products, with sales responsibilities for Alabama, Arkansas, Louisiana, Mississippi, and Tennessee.
Pasternack Enterprises, Inc., Irvine, CA, a leading manufacturer and supplier of RF, microwave, and millimeter wave products, announces the appointment of Mark Blackwood as the company’s Product Manager for Passive RF Components.
FIPA Inc., Cary, NC, a leading international manufacturer of vacuum technology and gripper systems for assembly equipment, is expanding its North American sales force with the addition of Joe Opal, the new Regional Sales and Marketing Manager for plastics.
MED Institute (MED), West Lafayette, IN, a Cook Group company, which for 32 years has served as an in-house contract research firm for Cook companies, announced that it will now offer its services to external medical device companies. MED provides product development, pre-clinical and clinical testing, and regulatory approval services for its medical devices.
Interlink Electronics, Inc., has moved its headquarters to 31248 Oak Crest Drive, Suite 110, Westlake Village, CA 91361.
Mitutoyo America Corporation, Aurora, IL, the world's largest provider of measurement and inspection solutions, announced the opening of its new M3 Solution Center in Marlborough, MA. Employees at this new 7,600-square foot facility can provide product demonstrations, assistance with application challenges and metrology solutions, as well as product and educational training seminars.
CIRTEC Medical Systems, LLC, East Longmeadow, MA, a leading provider of outsourced medical device manufacturing services for implantable and minimally invasive devices, announced plans to develop a new 35,000 sq. ft. advanced manufacturing facility in Enfield, CT. The facility will include a 5,000 sq. ft. ISO Class 7 clean room and an additional 6,000 sq. ft. of controlled environment assembly space.
Victrex Polymer Solutions, Thornton Cleveleys, Lancashire, UK, a division of Victrex plc, the world’s leading manufacturer of high performance polyaryletherketones (PAEK), has successfully commissioned the first production stream of its third PAEK manufacturing plant. The new facility became operational in April.
Jabil Circuit, Inc., St. Petersburg, FL, a global provider of design, engineering, manufacturing, and supply chain solutions, announced the opening of its Blue Sky Center in San Jose, California.
Olympus, a precision technology leader in designing and delivering innovative solutions for medical and surgical procedures, among other core businesses, opened a state-of-the-art Surgical Innovation Center in Brooklyn Park, MN. The new medical device R&D and manufacturing facility is designed to position the company for continued long-term growth in surgical technologies.
Oxford Instruments plc, Oxfordshire, UK, a leading provider of high technology tools and systems for industry and research, has acquired Medical Imaging Resources, Inc., Ann Arbor, MI, which specializes in mobile medical imaging labs.
Vascular Pathways, Inc., Boca Raton, FL, a manufacturer of wire-guided technology for peripheral intravascular access, has entered into a three-year contract with Novation, Irving, TX, a leading health care services company, to distribute its AccuCath line of catheters.
Helix Medical, LLC, Carpinteria, CA, a global manufacturer for the medical device and pharmaceutical industry, announced that it has acquired the silicone tubing product line of W. L. Gore & Associates, Inc., Flagstaff, AZ. Effective immediately, Helix Medical will supply Gore’s existing pharmaceutical and biotech customers with GORE® Silicone Tubing and Reinforced Silicone Hose for fluid transfer and peristaltic pump operations.
AMETEK, Inc., Berwyn, PA, a manufacturer of electronic instruments and gauges, said it has paid about $200 million to acquire Global Tubes, a manufacturer of high precision, small diameter metal tubing. Global Tubes is comprised of two businesses: Fine Tubes, based in Plymouth, UK, and Superior Tube, Collegeville, PA. Global Tubes will become part of Ametek’s electromechanical group.
Gardner Denver’s Medical Group, Quincy, IL, a leader in flow control solutions for medical and laboratory sectors, has closed on its acquisition of TriContinent Scientific, Inc., Grass Valley, Ca, a leading manufacturer of OEM precision syringe pumps and a supplier to leading medical and biotechnology diagnostic and analytics equipment manufacturers.
Accuray Incorporated, Sunnyvale, CA, a radiation oncology company that develops, manufactures, and sells precise tumor treatment solutions, has signed an agreement with MIM Software Inc., Cleveland, OH, a vendor of software for the radiation oncology, radiology, and nuclear medicine markets, to further develop adaptive therapy software for the TomoTherapy® and CyberKnife® product portfolios.
Welch Allyn, Skaneateles, NY, a leading medical diagnostic device company, has acquired Scale-Tronix, White Plains, NY, a leading manufacturer of medical scales and patient weighing systems.
Luna Innovations Incorporated, Roanoke, VA, which develops and manufactures fiber optic sensing and test & measurement products, and Advanced Photonix, Inc., Ann Arbor, MI, a leading supplier of optoelectronic sensors, devices, and instrumentation for the telecommunications, defense, medical, and industrial markets, have finalized a merger.
Phillips-Medisize Corporation, Hudson, WI, announced that two of its facilities, the Design and Development Center in Hudson, WI, and its Menomonie, WI, Medical Plant, are winners of the 2014 Wisconsin Corporate Safety Award.
Intersil Corporation, Milpitas, CA,a leading provider of innovative power management and precision analog solutions, has unveiled PowerNavigator™ version 5.2, a free, downloadable graphical user interface that helps system designers quickly configure, validate, and monitor their power supply architectures. To download the PowerNavigator 5.2 GUI, watch a tutorial, and begin a design, visit:www.intersil.com/powernavigator.
Thomson Industries, Inc., Wood Dale, IL, a leading manufacturer of mechanical motion control solutions, has released a new educational video to help design engineers to setup a limit switch correctly with a Thomson linear unit. To view the full video, please visit: http://www.thomsonlinear.com/website/com/eng/design_tools/techtips.php.
Amada Miyachi America, Inc., Monrovia, CA, a leading manufacturer of welding, marking, cutting, and micro machining equipment and systems, has launched a new program of annual service packages for its resistance welding equipment.
In late 2011, the owner of Diversified Plastics, Inc., Minneapolis, MN, sold his company to his employees through an Employee Stock Ownership Plan (ESOP). Just three years later, the company received the ESOP Company of the Year Award from the Minnesota/Dakotas Chapter of the ESOP Association. Diversified Plastics is a custom injection molder of high-precision, close tolerance, small- to medium-sized injection-molded components.