Here is the latest batch of news from the medical products community. Please click the link for more.

Regulatory Approvals

Two new 1.5T MR scanners from GE Healthcare, the Optima* MR360 Advance and Brivo* MR355 Inspire, have recently received FDA 510(k) clearance. Redesigned with new enclosures, the Optima MR360 Advance offers a newly-designed Express suite of coils with 16 channel head and neck array, anterior array, and flex coils that enable faster workflow.

Thermo Fisher Scientific Inc., Waltham, MA, announced that its facility in San Jose, CA, and its Franklin, MA, site have achieved ISO 13485 certification, an internationally recognized standard of quality management for the design and manufacture of medical devices. These sites are the first of Thermo Fisher’s liquid chromatography and mass spectrometry sites to achieve ISO 13485 certification.

Simbionix USA Corporation, Cleveland, OH, has received FDA clearance for its TEVAR (Thoracic Endovascular Aneurysm Repair) application for PROcedure Rehearsal StudioTM (PRS). This application joins the family of PRS cleared for marketing applications for Carotid Intervention and EVAR (Endovascular Aneurysm Repair) procedures.

NuvoLase Inc., Chico, CA, has received its own CE mark of approval for the PinPointe FootLaser. NuvoLase received ISO 13485 certification for its Quality Management System in September 2012.

LENSAR Inc., Orlando, FL, developer of the next generation LENSAR Laser System for refractive cataract surgery, announced that the company’s laser system has received 510(k) clearance from the FDA for the execution of arcuate incisions during cataract surgery.

Hitachi Medical Systems America, Inc SCENARIA 64-slice model.

Monteris Medical, Inc., Plymouth, MN, announced that the FDA has issued a second 510(k) clearance for its MRI-guided ablation device for brain tumors and other lesions. The NeuroBlate® System is a second-generation device employing a surgical laser to ablate diseased brain tissue with updated visualization provided by active MRI.

Olympus Medical Systems Group, a precision technology leader in designing and delivering innovative solutions in Medical and Surgical Products, among other core businesses, has received 510(k) clearance from the FDA for its Articulating HD 3D Laparoscopic Surgical Video System.

BD Medical, a segment of Becton, Dickinson and Company, Franklin Lakes, NJ, a global medical technology company, has launched a new passive needle guard technology, BD UltraSafe PLUS™, which has received 510(k) clearance as an anti-needlestick safety device.

Vetter, Ravensburg, Germany, a leading contract development and manufacturing organization, announced that its new center for visual inspection and logistics passed its first GMP inspection by the FDA. The facility was already granted manufacturing approval and cGMP certification for Europa from the RP Tuebingen, Germany in 2012.

Leadership News

Minnetronix, Inc., St. Paul, MN, a medical device design, manufacturing, and IP innovation services firm, announced that Phil Ankeny joined the company as Chief Financial Officer beginning April 1.

Indium Corporation, Utica, NY, has created a Nanotechnology Team to support the company’s continued expansion into novel nanotechnology materials and markets. Led by Andy C. Mackie, PhD, MSc, Senior Product Manager for Semiconductor Materials, the team includes: Dr. Ning-Cheng Lee, Vice President of Technology; Jim Slattery, Vice President of Metals and Compounds Technical Service Group; Carol Gowans, Incubator Market Manager; and Jim Hisert, Applications Engineer for Thin-Film and Solar Assembly Materials.

Freedom Innovations LLC, Irvine, CA, a manufacturer of advanced technology prosthetic devices, has named Rob Cripe as its Senior Vice President of Global Marketing.

Toshiba America Medical Systems, Inc., Tustin, CA, a leading worldwide provider of medical diagnostic imaging systems, announced that Nancy Gillen has been named vice president, Marketing.

OmniGuide, Inc., Cambridge, MA, a commercial stage medical device company, has appointed Sharon Timberlake as Vice President of Regulatory Affairs and Quality Assurance, and Manny Avila as Vice President of Global Sales.

Microline Surgical, Inc., Beverly, MA, a manufacturer of high quality reposable surgical laparoscopic instruments, has appointed Sharad H. Joshi as the company’s new President and Chief Executive Officer, effective April 1, 2013.

AliveCor, Inc., a premier digital health company providing the first mobile device–based ECG monitor for the iPhone, the AliveCor Heart Monitorhas appointed Daniel J. Sullivan as President, Chief Executive Officer and member of the company’s Board of Directors.

EXSYS Tool, Inc., San Antonio, FL, announced the addition of John Yeip as a new territory manager for Tennessee, and North and South Carolina. This is a new position added in response to the company's growth in the region in local industries that include medical and contract manufacturing.

Gefran Inc., Winchester, MA, announced that Mick White has been named the company’s Southeast Regional Sales Manager Industrial Sensor and Automation Products for North America and Matt Overhulse has been named the Great Lakes Regional Sales Manager Industrial Sensor and Automation Products for North America.

Precision Spine, Inc., Parsippany, NJ, has appointed Tony Dimun as a member of the Company’s Board of Directors and as a Special Advisor to the Company for business development and mergers and acquisitions.

The Medical Device Innovation Consortium (MDIC), a public-private partnership committed to improving patient health through the application of shared knowledge in regulatory science, announces the election of officers to its board of directors. The MDIC named William Hawkins III, president and CEO, Immucor, Inc., to serve as chairman; Allan Coukell, deputy director of medical programs at The Pew Charitable Trusts, to serve as vice chair; Michael Minogue, president, CEO and chairman, Abiomed, Inc., to serve as secretary and David Perez, president and CEO, Terumo BCT, to serve as treasurer.

The MDIC also named the following individuals to its board of directors: Glenn Criser, senior vice president, quality, regulatory and clinical affairs, Biomet, Inc.; Vincent Forlenza, president, CEO and chairman, Becton, Dickinson and Company; Kathy Hudson, PhD, deputy director of science, outreach and policy, National Institutes of Health (NIH); Tamara Syrek Jensen, JD, deputy director, coverage and analysis group, Center for Medicare & Medicaid Services (CMS); Richard Kuntz, MD, senior vice president and chief scientific, clinical and regulatory officer, Medtronic, Inc.; Dee Mellor, chief quality officer, GE Healthcare; Daniel Moore, president and CEO, Cyberonics, Inc.; Ross Jaffe, managing director, Versant Ventures and representing the National Venture Capital Association (NVCA); Peter Saltonstall, president and CEO, National Organization for Rare Disorders (NORD); Randall Schiestl, vice president, research and development and global technology, Boston Scientific Corporation; Jeffrey Shuren, MD, JD, director, Center for Devices and Radiological Health (CDRH), Food and Drug Administration (FDA); Dale Wahlstrom, president and CEO, LifeScience Alley and The BioBusiness Alliance of Minnesota; and Nadim Yared, president and CEO, CVRx, Inc. Dale Wahlstrom will serve as interim executive director of the MDIC.

Expansions/Moves

Daktari Diagnostics Inc., Cambridge, MA, which develops diagnostic tests for global health conditions, has announced plans to locate its global manufacturing base in Inverness, Scotland, to develop its life-saving HIV blood monitoring technology.

Seco Tools announced that it will relocate its Custom Tooling unit to its North American headquarters in Troy, MI. This will allow the company to develop a center of excellence in engineered customer solutions by bringing custom tooling manufacturing together with engineering and design.

Flambeau Medical Markets Group,Phoenix, AZ, a diverse high-tech manufacturing company will open its new facility in Phoenix on May 1. The new facility, located adjacent to Flambeau’s two-building manufacturing campus, comprises 16,500 square feet, of which 3,600 square feet is Class 7 clean room manufacturing with state-of-the-art all-electric plastics injection molding and automation equipment.

OnCore Manufacturing, LLC, Fremont, CA, a provider of electronic manufacturing services, will expand its Mexico presence with the addition of a new facility in Tijuana, Baja California, Mexico. Located in the Otay-Caliente Industrial Park, the new 88,000 square-foot facility, with the ability to expand to 175,000 square-feet, is scheduled for volume production this month.

Point Grey, Richmond, BC, Canada, a world-leading designer and manufacturer of innovative, high-performance digital cameras, has added 15,000 square feet to its Canadian headquarters to increase manufacturing capacity and accommodate a world-class warehousing facility. The ISO 9001:2008 certified facility is now a total of 55,000 sq feet.

Mergers/Acquisitions/Collaborations

Kollmorgen, Radford, VA, has acquired Istanbul, Turkey-based Elsim Electrotechnical Systems A.S. Elsim will continue to be a family-run, value-add motion control solutions provider delivering turnkey solutions for Turkish and Eastern European OEMs.

Milacron LLC, Cincinnati, OH, a global plastics industry leader and provider of premium metalworking fluids, has completed the acquisition of Mold-Masters, Georgetown, Ontario, Canada.

OFS, Norcross, GA, a leading designer, manufacturer, and supplier of innovative fiber optic network products, has been appointed as the authorized North American distributor of products from SEDI-ATI Fibres Optiques, Courcouronne, France, a designer and manufacturer of innovative fiber optic components and assembly products.

Southco, Inc., Concordville, PA, a global leader in engineered access solutions, announced its acquisition of Unikey Industrial Components in São Paulo, Brazil. With this acquisition, Southco expands its broad range of engineered access hardware solutions and extends the company’s global market presence into South America.

Miscellaneous

Nordson EFD, a Nordson company, a global leader in precision fluid dispensing and fluid management systems, will celebrate its 50th anniversary throughout 2013 with participation in numerous North American and international trade shows, a global advertising and public relations campaign, and special customer incentive programs.

MSC Industrial Supply Co., Melville, NY, recently sponsored Pine Lake Preparatory’s FIRST® Team SPORK in the 2013 FIRST Robotics Competition. As a team sponsor, MSC, a leading distributor of metalworking and maintenance, repair and operation supplies, helped promote careers in engineering and manufacturing while providing students with the tools necessary to design, build and test components for their team’s robot.


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Medical