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

Regulatory Approvals, Standards, and Launches

W.L. Gore & Associates, Inc., Flagstaff, AZ, a global manufacturer of electronics, fabric, industrial and medical products, announced that the GORE® VIABAHN® Endoprosthesis has received the CE Mark approval to improve blood flow in symptomatic obstruction of peripheral veins, excluding the venae cavae and pulmonary veins.

DePuy Synthes Spine, Raynham, MA, the second largest spine company in the world, announced that it has received FDA 510(k) clearance for its VEPTR and VEPTR II vertical expandable prosthetic titanium rib devices to treat thoracic insufficiency syndrome.

St. Jude Medical, Inc., St. Paul, MN, a global medical device company, announced CE Mark approval of its Quadra Allure MP cardiac resynchronization therapy pacemaker (CRT-P). The Quadra Allure MP is the world’s first and only quadripolar CRT-P with the MultiPoint Pacing option.

IlluminOss Medical, East Providence, RI, a commercial stage medical device company focused on minimally invasive orthopedic fracture repair, has been issued two new patents related to its internal bone fixation system.

Cianna Medical, Inc., San Antonio, TX, a medical device company manufacturing breast cancer treatment technology, announced it has received FDA clearance for the SAVI SCOUT® surgical guidance system, a novel technology that uses real-time audible and visual indicators to give surgeons a precise way to target tissue during breast conservation surgery.

MED-EL USA, Durham, NC, announced it has received FDA approval of the WaterWear fully waterproof cover for the all-in-one RONDO Audio Processor for cochlear implants. In addition, the FDA has approved the company’s new SONNET behind-the-ear audio processor.

JDRF, New York, NY, and the Centre for Global eHealth Innovation at the University Health Network (UHN) in Toronto, Canada, announced publication of interoperability standards for diabetes devices, such as insulin pumps, blood glucose meters, and continuous glucose monitors, communicate with one another and with other devices.

Merit Medical Systems, Inc., South Jordan, UT, a leading manufacturer of disposable devices used primarily in cardiology, radiology, and endoscopy, has received FDA 510(k) clearance for three products: the ReSolve® Biliary Locking Drainage Catheter, the ONE Snare® Endovascular Microsnare System and the AEROmini™ Tracheobronchial Stent System. They are all scheduled to be launched in the US early in 2015.

COMSOL, Inc., Burlington, MA, has launched COMSOL Server™, a new product developed specifically for running applications built with the COMSOL Multiphysics 5.0 Application Builder, which enables the distribution of applications, allowing design teams, production departments, and others to share applications throughout an organization using a Windows®-native client or web browser.

ReFlow Medical, Inc., San Clemente, CA, has received FDA clearance for US commercialization of its SpeX™ Shapeable Support Catheter for use in the peripheral vasculature as well as the first US clinical cases with the device.

PENTAX Medical Company, Montvale, NJ, a healthcare industry leader in endoscopic imaging, announces the US and Canadian launch of PENTAX Medical i10 Series HD+ (plus) Endoscopes, devices that provide the highest resolution HD images ever available for colonoscopy and gastroscopy procedures that screen for and treat GI disorders.

Morgan Advanced Materials, Windsor, UK, announces its extensive range of ceramic capacitors for high voltage DC and AC and high power radio frequency applications, which the company says are ideal for laser power supplies, medical power supplies, and electrical distribution, as well as high voltage electrostatic applications and powerline coupling.

Leadership News

TransEnterix, Inc., Research Triangle Park, NC, a medical device company that is pioneering the use of robotics and flexible instruments to improve minimally invasive surgery, today announced the appointment of William N. Kelley, MD, to serve on its Board of Directors.

Incremotion Associates, Thousand Oaks, CA, announced that Dan Jones, President and Owner, has received the lifetime achievement award in motion control for “Outstanding Contributions to the Electric Machines Industry” from the Electric Motor Education and Research Foundation and the SMMA-Motors and Motion Association.

Quality Tech Services, Inc. (QTS), Bloomington, MN, a medical device outsourcing services provider, announced the promotion of Bob Lord to Vice President of Sales and Marketing.

Expansions/Spinoffs/New Services/Moves

RTP Company, Winona, MN, a global compounder of custom engineered thermoplastics, has announced the acquisition of three production facilities from Alloy Polymers, Inc., a leading provider of specialty, value-added thermoplastic compounding services. The three plants, located in Richmond, VA, Crockett, TX, and Orange, TX, will be merged with the previous RTP Company acquisition of Alloy Polymers’ Gahanna, OH, plant.

Smiths Medical, which makes infusion pumps and other medical equipment, is moving its headquarters from Arden Hills, MN, to Plymouth and will relocate some out-of-state jobs to the new site.

Mergers/Acquisitions/Collaborations/Licensing/Distributors

Mouser Electronics, Inc., Mansfield, TX, a leading global distributor for semiconductors and electronic components, has expanded its partnership and worldwide distribution agreement with Analog Devices Inc. (ADI), Norwood, MA, to include ADI's recently acquired RF and microwave products from Hittite Microwave, Chelmsford, MA, marketed as "Hittite Microwave Products from Analog Devices”.

Welch Allyn, Inc., Skaneateles Falls, NY, a manufacturer of medical-diagnostic equipment, has acquired substantially all the assets of HealthInterlink, LLC, Omaha, NE, a medical software company and developer of a software-based remote patient vital-signs monitoring system.

ParkerHannifinCorporation, Cleveland, OH, a global leader in motion and control technologies,has completed an investment agreement with Freedom Innovations LLC, Irvine, CA, which designs, manufactures, and markets advanced technology lower extremity prosthetic devices. The agreement expands Parker and Freedom Innovations’ partnership, which began in July 2013 with a technology collaboration related to intelligent, powered orthotics and prosthetics.

Leica Biosystems, Nussloch, German, and the Mayo Clinic Department of Laboratory Medicine and Pathology Rochester, MN, announced a collaboration to develop the next generation of cytogenetics imaging software.

Epoxy Technology Inc., Billerica, MA, a leading manufacturer of high performance specialty epoxy, UV, and hybrid adhesives for 48 years, announces a change in its distributor covering France, Algeria, Morocco, and Tunisia from Techni Industries France to FT Polymer SAS . Stéphane Fournier will be leading FT Polymer as General Manager.

Royal Philips, Amsterdam, The Netherlands, a global a leader in cardiac care, acute care, home healthcare, energy efficient lighting solutions, and new lighting applications, has agreed to acquire Volcano Corporation, a maker of catheter-based imaging and measurement devices. The transaction is expected to close in the first quarter of 2015.

Blackrock Microsystems LLC, Salt Lake City, UT, announced that it has struck an agreement with Brown University, Providence, RI, to license and commercialize a wireless neural activity monitoring system that will liberate neuroscientists from the wires and cables that have burdened their research for decades. They say that this wireless system is a major step forward in brain-interface technology. This research was published in the January issue of Medical Design Briefs.

Varian Medical Systems, Palo Alto, CA, announced that it plans to acquire cancer screening software maker MeVis Medical Solutions, Bremen, Germany, which will give Varian access to image processing software for breast, lung, liver, prostate, and colon cancer screening, as well as the MeVisLab software platform. T

Miscellaneous

Miyachi America Corporation, Monrovia, CA, a leading manufacturer of welding, marking, cutting, and micro machining equipment and systems, recently donated an LMF2000 fiber laser marker along with related safety equipment to Workshops for Warriors (WFW), a nonprofit organization that provides vocational training to returning, wounded, and disabled veterans of the U.S. Armed Services. Partnering in the donation is Technimark, one of Miyachi’s suppliers, which donated a fume extractor for the equipment, and Directed Light, Inc., which donated laser safety glasses.

BioDigital, Inc., New York, NY, developer of the 3D interactive virtual human body platform, the BioDigital Human , announced that it has expanded its product offerings to serve Android mobile devices.

Mouser Electronics, Inc., Mansfield, TX, announced the introduction of its new Motor Control Applications site . Mouser's new applications site  provides developers with the resources they need to learn about the latest advances in motor control, and the newest components available from Mouser Electronics for building motor control systems.

Averna, Montreal, Canada,an industry-leading developer of test solutions and services for communications and electronics device-makers worldwide, announced the launch of its online Resource Center dedicated to test engineering. See http://www.averna.com/en/resource-center .

Bauer Plastics Technology Group, Norfolk, VA, has announced a Trade-In/Trade-Up Program to kick off promotions for NPE 2015–The International Plastics Showcase. Between January 1 and March 23, customers will receive a $5,000 equipment credit for any existing gas assist control unit from any manufacturer of gas assist control systems, which can be used towards the purchase of either a new Bauer unit. For more information, visit www.bauercomp.com .