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

Regulatory Approvals and Launches

Sumitomo Heavy Industries, Ltd., Tokyo, Japan, and Allentwon, PA, has received FDA 510(k) clearance of its Proton Therapy System. It is the first 510(k) cleared medical device for Sumitomo.

BonAlive Biomaterials Ltd., Turku, Finland, has received CE Mark approval for its BonAlive Putty, a bone graft substitute to treat bony voids and gaps.

NEC Display Solutions of America, Itasca, IL, a leading provider of commercial LCD display and projector solutions, announced the FDA 510(k) market clearance of its 24-inch MultiSync® MD242C2 referral-grade, widescreen display for diagnostic review applications in healthcare organizations.

TomTec Imaging Systems GmbH, Munich, Germany, announced FDA 510(k) clearance for its new TomTec-ArenaTM software solution, a suite of clinical applications to review, analyze, and quantify medical image data in multiple dimensions.

The Solviva® Biomaterials line of high-performance plastics for implantable applications, manufactured by Solvay Specialty Polymers, Brussels, Belgium, is now commercially available in Brazil, the company has announced. The biomaterials line, previously available in the US, Europe and China, is targeted to meet growing demand in the Brazilian market.

EFE Laboratories, Philadelphia's oldest contract manufacturer and OEM of electromechanical software and engineering solutions for communications, industrial controls, aerospace, and medical device industries, announced that the company is now AS9100C certified.

Leadership News

Intelligrated®, Mason, OH, a leading automated material handling solutions provider, announced the hiring of David Erickson as Vice President, Software Development, for its NY-based software subsidiary company, Knighted®.

Rob Lyles, a veteran leader of the Peripheral Intervention (PI) division at Cook Medical, Bloomington, IN, has been promoted to Executive Vice President. He will transition his current responsibilities as Global Leader for the PI division to Mark Breedlove, a long-time leader within the division.

Bruce Wilner, Senior Scientist at Meggitt Sensing Systems, Sunnyvale, CA, has been selected as the first recipient of the newly created SAVE Lifetime Innovation Award from the Shock and Vibration Exchange (SAVE). The award is presented to an individual whose innovations and professional dedication in the field of shock and vibration have significantly improved the state of the art or state of practice. Over his 52-year career with the company, he has been awarded 25 patents, most of which relate to MEMS parts that are still in production today.

Expansions/Moves

Phillips-Medisize Corporation, Hudson, WI, announces the start of production and completion of the 60,000 square feet expansion to its Kontiolahti, Finland, site. The expansion includes 12,900 square feet (1,200 square meters) of Class 8 clean room manufacturing and assembly, and has space for the additional expansion for molding machines and assembly. The site focuses on the industrialization and production of inhalers, insulin pens, transfer devices, and syringes.

Mergers/Acquisitions/Collaborations

Covidien, Dublin, Ireland, a leading global healthcare products company, announced a definitive agreement to acquire Given Imaging, Yoqneam, Israel, a leader in gastrointestinal medical devices. This provides Covidien additional scope to serve the global gastrointestinal market.

Teleflex Incorporated, Limerick, PA, a leading global provider of medical devices for critical care and surgery, announced that it has completed the previously announced acquisition of Vidacare Corporation, a leading provider of intraosseous, or inside the bone, access devices.

Kyocera Industrial Ceramics Corp., Hendersonville, NC, will manufacture medical devices for Amedica Corp., Salt Lake City, UT, a biomaterials company, at Kyocera's Vancouver manufacturing facility, the two companies have announced. The collaboration includes the manufacture of Amedica's silicon nitride spinal interbody implant devices.

HeartWare International Inc., Framingham, MA, which develops and manufactures heart-related medical devices, has acquired CircuLite Inc., Teaneck, NJ, a medical device manufacturing company.

Mason Wells has closed on the acquisition of the rigid medical packaging business of Sealed Air Corporation. The business will be owned by Nelipak Corporation, a newly formed company, and operate under the name of Nelipak® Healthcare Packaging, Cranston, RI.

Miscellaneous

FIRST® (For Inspiration and Recognition of Science and Technology), a not-for-profit organization founded by inventor Dean Kamen to inspire young people’s interest and participation in science and technology, announced that five award-winning FIRSTRobotics Competition teams and their robots had the honor of opening the 87th Annual Macy’s Thanksgiving Day Parade on in New York City. The robots leading the parade were designed and built for the 2013 season challenge, and modified by the students to perform tasks specifically for the parade.

Olympus America Inc., Scientific Equipment Group, Center Valley, PA, is partnering with the Smithsonian’s National Museum of Natural History, Washington, DC, to create Q?rius,a new hub of scientific activity and education. Olympus is donating more than 50 microscopes and imaging systems to let students explore more than 6,000 museum artifacts. The exhibit, combines labs and creative studios for interactive learning.

Thermacore, Lancaster, PA, a leading provider of advanced thermal solutions, has won the award for Excellence in Innovation in the 2013 Manufacturing Awards from MANTEC, a non-profit organization that works to strengthen manufacturing companies in South Central Pennsylvania.

Effective January 1, 2014, GF AgieCharmilles, Lincolnshire, IL, will become GF Machining Solutions, a name change that underscores that Georg Fischer AG (GF) is a unified company with three divisions. Today, GF AgieCharmilles has grown to offer one of the industry’s most diverse portfolios, including milling, EDM, laser texturing, spindles, tooling, automation and customer services. The new name emphasizes the company’s role as a total solutions provider.

The German Future Prize was presented to a team of experts from TRUMPF Laser GmbH + Co. KG, Schramberg, Germany, Bosch, Stuttgart, Germany, and the University of Jena. Federal President Joachim Gauck awarded the prize to Dr. Jens König (Bosch), Dr. Dirk Sutter (TRUMPF), and Professor Stefan Nolte (University of Jena). The three researchers have established ultrashort pulse lasers as a new tool for industrial production with virtually unlimited possibilities.

MSC Industrial Supply Co., Melville, NY, a leading distributor of metalworking and maintenance, repair and operations solutions, services, and supplies to North American manufacturers, has increased its selection of high-quality K