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

Regulatory Approvals and Launches

K2M Group Holdings, Inc. Leesburg, VA, a global medical device company focused on designing, developing, and commercializing innovative spine technologies, announced that the company has received FDA 510(k) clearance to market its CASPIAN® Occipital Anchor Spinal System, has introduced the SERENGETI® Minimally Invasive Retractor System in Japan, and has launched the CAYMAN® Minimally Invasive Plate System in the US, Australia, and the UK.

ZOLL Medical Corporation, Chelmsford, MA, a manufacturer of medical devices and related software solutions, announced that its Japanese subsidiary, Asahi Kasei ZOLL Medical, has received Shonin approval from the Japanese Ministry of Health, Labour, and Welfare to enter the Japanese market with itsR Series® Monitor/Defibrillator.

Codman Neuro, Raynham, MA, a global neurosurgery, neurovascular and neuromodulation company and part of the DePuy Synthes Companies of Johnson & Johnson, announced the launch of the ENVOY® DA XB Distal Access Guiding Catheter and the 7F ENVOY® Guiding Catheter for neurovascular procedures.

Ostar Healthcare Technology, Vancouver, WA, a medical device and healthcare IT company, has launched its P Series cloud-based telehealth blood pressure monitoring system, Ostar P200, in North America.

SynCardia Systems, Inc., Tucson, AZ, received FDA approval for the SynCardia temporary Total Artificial Heart with SynHall™ valves, giving the company control over the last key component to manufacture the Total Artificial Heart.

Adesto Technologies, Sunnyvale, CA, an inventor and market leader of the world’s lowest power memory solutions, announced the launch of the RM24EP family of sterilization-tolerant, low energy non-volatile memory products targeting wearable and other energy-conscious medical devices.

Cutera, Inc., Brisbane, CA, a leading provider of laser, light, and other energy-based aesthetic systems, announced that its enlighten™ laser platform received FDA 510(k) clearance to treat benign pigmented lesions. The device is the first dual wavelength and dual pulse duration picosecond laser system cleared for sale in the US, the company said.

Leadership News

Edmund Optics, Barrington, NJ, a leading producer of optics, imaging, and photonics technology, announced three key promotions in their sales and business units. Greg Hollows was promoted to Director of the Imaging Business Unit, Anthony Artigliere was named Director of the new Optics Business Unit, and Todd Sierer was announced as the new Director of Americas Sales.

Neuromod Devices, Dublin, Ireland, has appointed Padraig Rushe as its new Chief Commercial Officer as it readies to launch a medical device to treat tinnitus across Europe next year.

JenaValve Technology, Inc., Irvine, CA, a manufacturer and marketer of transcatheter aortic valve implantation systems to treat aortic valve disease, announced that Stefan Schreck, PhD, has been named the company’s new Chief Technology Officer.

Oxford Performance Materials, Inc., (OPM) South Windsor, CT, a leading advanced materials and additive manufacturing company, announced the appointment of Severine Zygmont as President of OPM Biomedical. In addition, the company was named the "Best Global Company for 3D Healthcare Innovation" by The New Economy Awards.

Smithers Rapra, Akron, OH, a world leader in rubber, plastics, and composites testing expertise, announced that Richard Salzstein, PhD, has been named Business Development Manager for its medical device and pharmaceutical markets.

Bacterin International Holdings, Inc., Belgrade, MT, a leader in the development of bone graft material and coatings for medical applications, has added David Goodman, MD, MSE, to its board of directors.

The IPC – Association Connecting Electronics Industries, Bannockburn, IL, announces that Teresa Rowe has joined the IPC staff as director of assembly and standards technology. She will direct and manage the development of standards for electronics assembly materials and processes.

Expansions/Moves/New Services

Medtronic, Minneapolis, MN, a world leader in medical device technology, has opened a new manufacturing facility in China to focus on hemodialysis system manufacturing.

Newcomb Spring Corp., Decatur, GA, announced that the company is using an innovative measurement system called the Keyence Instant Measurement System to improve the speed and accuracy of its quality control processes for stampings, flat springs, and wire forms.

AdvancedCath, Watertown, MA, announced the opening of its new 20,000 square foot manufacturing facility in Flexipark Free Trade Zone located in San Rafael, Costa Rica, where it will manufacture sophisticated guidewires, advanced catheters components, and complete balloon catheter solutions.

Mergers/Acquisitions/Collaborations/Licensing

St. Jude Medical, Inc., St. Paul, MN, a global medical technology leader, is acquiring NeuroTherm Inc., Wilmington, MA, which specializes in chronic pain management devices, particularly in the treatment of spinal pain using radiofrequency ablation.

Stryker Corp., Kalamazoo, MI, a leader in the worldwide orthopaedic medical technology market, is acquiring Small Bone Innovations, Morrisville, PA, which makes combination plastic-and-metal devices used in small-joint procedures, such as fingers and wrists.

Nordson Corporation, Westlake, OH, which engineers, manufactures and markets differentiated products and systems used for precision dispensing, plastic extrusion and injection molding, electronics testing and inspecting, and surface preparation, has entered into a definitive agreement to acquire Avalon Laboratories Holding Corp., Los Angeles, CA, a leading designer and manufacturer of highly specialized catheters and medical tubing products for cardiology, pulmonology, and related applications. Avalon will operate as part of Nordson’s Advanced Technology Systems segment.

The Lubrizol Corporation, Wickliffe, OH, a Berkshire Hathaway company, and an innovative specialty chemical company, has ventured into the medical device market by acquiring Vesta Inc., a maker of catheters and tubing based on silicone and thermoplastics.

Tecomet Inc., Wilmington, MA, a precision contract manufacturer supporting the medical device and aerospace industries, has signed a definitive agreement with Symmetry Medical Inc. to acquire its OEM Solutions, Warsaw, IN, business segment, which manufactures precision surgical instruments and orthopedic implants for global medical device OEMs.

3D Systems, Rock Hill, SC, has entered into a definitive agreement to acquireSimbionix, Cleveland, OH, a global leader in 3D virtual reality surgical simulation and training.

Varian Medical Systems, Inc., Palo Alto, CA, a leading manufacturer of medical devices and software to treat cancer, has acquired certain assets of Transpire, Inc., Gig Harbor, WA, including the Acuros® dose calculation software that has been integrated into Varian's market-leading BrachyVision™ and Eclipse™ treatment planning software products.

Cadence, Inc., Staunton, VA, a leading contract manufacturer and maker of complex components and sub-assemblies for medical device and life sciences companies, has acquired three operating business units of Plainfield Precision Holdings in Sturgeon Bay, WI, Plymouth, MA, and Santo Domingo, Dominican Republic. Plainfield Precision Holdings is a highly specialized solutions provider of assembled products that integrate stamped metal and molded plastic components.

Averna, Montreal, Canada, a developer of test solutions and services for communications and electronics device-makers worldwide, and JOT Automation, Oulu, Finland, a leading supplier of automated test and production solutions, announced a technology partnership for the Americas whereby Averna will act as a lead distributor and integrator of JOT Automation products for the Americas. Averna will also integrate some of JOT’s products into existing Averna test platforms to extend its product offering.

Tianma Microelectronics Co., Ltd., Shenzhen, China, an LCD manufacturer, has completed the acquisition of its five production lines in Japan, Shenzhen, Shanghai, and Wuhan, and increased its investment in its Chengdu facility.

Sterigenics International LLC, Deerfield, IL, a leading global provider of outsourced contract sterilization services, has completed its acquisition of Nordion Inc., Ottawa, Canada, a leading provider of sterilization technologies and medical isotopes, creating the only vertically integrated sterilization company in the world.

Greatbatch, Inc., Frisco, TX, which develops and manufactures critical medical device technologies for the cardiac, neuromodulation, vascular and orthopaedic markets and batteries for the medical market, has acquired CCC Medical Devices, Montevideo, Uruguay, an active implantable medical device systems developer and manufacturer.

Miscellaneous

Averna, Montreal, Canada, a developer of test solutions and services for communications and electronics device-makers worldwide, announced that CableLabs, Louisville, CO,a non-profit research and development consortium, will join its DOCSIS® 3.1 Protocol Analyzer Early Adopter Program. As a participant to the program, CableLabs will add its voice and experience to the development and review process for Averna’s next-gen DOCSIS 3.1 Protocol Analyzer. Averna also was named National Instruments 2014 Alliance Partner of the Year for the Americas during NIWeek, the annual global conference on graphical system design.

Frost & Sullivan, Mountain View, CA, has recognized Mobius Imaging, Ayer, MA, with its 2014 North America Frost & Sullivan Award for New Product Innovation Leadership for the Mobius Airo Mobile Intraoperative CT, a one-of-a-kind mobile 32-slice CT scanner with the industry's largest gantry opening, 107 cm, which allows the system to scan the patient in the treatment position.

To celebrate 30 years of its line of self-lubricating plastic bearings, called “iglide,” tied into the company’s 50 anniversary, igus, East Providence, RI, has been traveling around the world with its orange iglide car, retrofit with 56 of igus’ plastic bearings in applications including the throttle valve, windshield wipers, alternator, and more. Now, starting in Alaska, the iglide car, staffed with a team of igus representatives, is setting off across the United States and Canada, visiting customers across a massive range of industries, from automotive and motorcycle manufacturers, to aerospace, to manufacturing equipment and more. To follow along with the iglide on tour car, visit the igus blog at http://igus.com/blog .

Connecticut Spring & Stamping (CSS), Farmington, CT, a manufacturer of precision parts for the medical, aerospace, firearms and defense industries worldwide, announces its newly updated and redesigned website, located at www.ctspring.com .

TRUMPF Inc., Farmington, CT, presented its 2014 sales achievement awards to the following: Mid Atlantic Machinery, Inc., Harrisburg, PA, received the Outstanding Representative Performance Award; FabMore Machinery, Carmel, IN, received the Most Improved Performance Award; and ICON Machine Tool Inc., St. Louis, MO, received the Sustained Excellence Award.

Medigus Ltd., Omer, Israel, a medical device company developing and commercializing micro-cameras and minimally invasive endosurgical tools and procedures, announced that NASA has incorporated its micro ScoutCam™ 1.2, the world's smallest camera, into the NASA Visual Inspection Poseable Invertebrate Robot (VIPIR) tool.

Teleflex Incorporated, Wayne, PA, a leading global provider of medical devices for critical care and surgery, is commemorating the 200thanniversary of the Pilling®Brand in the marketplace. The Pilling® Brand was established as one of the first surgical instrument manufacturers in the US.