Here is the latest batch of news from the medical products community. Please click the link for more.
Regulatory Approvals and Launches
Covidien Japan Inc., has received Shonin approval from the Japanese Ministry of Health, Labor, and Welfare for its Endo GIA™ Reinforced Reload with Tri-Staple™ technology.
Benvenue Medical, Inc., Santa Clara, CA, reports that its Kiva® VCF Treatment System, a novel implant-based solution for vertebral augmentation, received FDA 510(k) clearance to treat spinal fractures.
ReCor Medical, Palo Alto, CA, has received the CE Mark for t its Paradise System™ ultrasound-based system for renal denervation.
Biotronik, Berlin, Germany, received the CE Mark for its Passeo-18 Lux drug releasing balloon, and the company is beginning commercial efforts in all CE Mark countries.
Claret Medical, Santa Rosa, CA, has received the CE Mark for its next-generation Sentinel Cerebral Protection System, the first system on the market to remove embolic matter following cardiac procedures. It will be launched immediately is select CE Mark countries.
IlluminOss Medical, East Providence RI, a medical device company pioneering the development of minimally invasive fracture fixation technologies, has launched its proprietary Photodynamic Bone Stabilization System in Spain and Israel.
Ulthera, Inc. , Mesa, AZ, a global medical device company focused on developing and commercializing technologies for aesthetic and medical applications, announced that the FDA cleared its ultrasound platform device, the Ulthera System, to visualize the dermal and subdermal layers of tissue during the non-invasive lifting treatment, Ultherapy.
B. Braun Medical Inc., Bethlehem, PA, a leader in infusion therapy and pain management, has received FDA approval of its E3™ IV containers, a first of its kind offering that will provide highest quality, easy to use IV containers not made with natural rubber latex, DEHP, or PVC.
SL Power Electronics, Ventura, CA, an industry leader in the design and manufacture of rugged, highly reliable power supplies for OEM applications, announced the appointment of Timothy F. Croal as President.
Colder Products Company, St. Paul, MN, a leading provider of quick disconnect couplings, fittings, and connectors, has hired Stephen Elliott as its new Regional Sales Manager for the Great Lakes region of North America.
Nelipak Healthcare Packaging, Cranston, RI, a leading provider of custom thermoformed packaging, has appointed Elizabeth Nugent to the role of Director of Global Quality & Regulatory Affairs.
Medical Murray, North Barrington, IL, has appointed Eric Leopold as Vice President of Business Development for its Western US region.
Mike Cyros, Chief Commercial Officer, Allied Vision Technologies, Barnaby, Canada, was presented with the 2014 AIA Achievement Award, the vision and imaging industry’s top leadership award.
Phillips-Medisize Corporation, Hudson, WI, has signed a supply agreement for insulin pen components with Sanofi, a leader for diabetes treatment. As a result, injection pen component production at the plant in Kontiolahti, Finland, has been expanded with an automated production line. Phillips-Medisize implemented the project, including all validations required, and delivered validated product in less than 12 months. The final pen assembly will be launched out by Sanofi in Frankfurt, Germany.
Medtronic, Minneapolis, MN, has shifted its regional Middle East and Africa headquarters from Beirut, Lebanon, to a "freezone" in the Dubai, UAE, DuBiotech Research Park.
Bruker Corporation, Billerica, MA, announced the official opening of a new Preclinical Imaging Center of Excellence for the Americas. The facility offers advanced development, demonstration, and support facilities for the company’s portfolio of preclinical imaging instrumentation and multimodal platforms.
EJ BioMed, Denver, CO, an Eldon James Company, announced that its new, state-of-the-art, 75,000 square foot manufacturing facility is now online, fully functioning and validated under its existing ISO 13485:2003 certification.
Mazak distributor Northwest Machine, serving Minnesota, South Dakota, North Dakota, and Western Wisconsin, will host a special grand opening for its new headquarters in Rogers, MN, from April 30 to May 1.
COMSOL, Inc., Burlington, MA, has formed a Brazilian subsidiary with a new office in Curitiba, Paraná. In addition to providing technical support, comprehensive training, hands-on workshops, and customer events in Brazil, COMSOL has also announced its new website www.br.comsol.com/products has product descriptions translated into Portuguese.
Laserage Technology Corporation, Waukegan, IL, a global contract manufacturing source for precision laser processing, has completed its acquisition of Venta Medical LLC, Union City, CA, an ISO 13485 Certified, turn-key medical contract manufacturer.
Covidien Plc, Dublin, Ireland, has completed the sale of its Confluent Surgical product line to Integra LifeSciences Corporation, Plainsboro Township, NJ.
Wright Medical Group, Inc., Memphis, TN, a specialty orthopaedic company has acquired Solana Surgical, LLC, Memphis, TN, a global extremity orthopedic company, and entered into a definitive agreement to acquire OrthoPro, LLC, Salt Lake City, UT, a provider of innovative foot and ankle products.
Accellent Inc., Wilmington, MA, a leading provider of fully integrated outsourced manufacturing and engineering services to the medical device industry, and Lake Region Medical, Chaska, MN, a privately held, Original Development Manufacturer of minimally invasive devices and delivery systems to the cardiology and endovascular markets, announced that they have entered into a definitive agreement whereby Accellent will acquire Lake Region Medical.
Resonetics, LLC, Nashua, NH, and Australian Scientific Instruments Pty Ltd., (ASI) Canberra, Australia, have established an alliance for future marketing, development, manufacture, and support of the RESOlution laser ablation product line. ASI will assume responsibility for worldwide marketing and sales of the instruments. This is the first step towards ASI acquiring the complete RESOlution product line later this year.
Camstar Systems, Inc., Charlotte, NC, announced thatBoston Scientific, ConforMIS, and Infineon Technologies have been selected as Exclusive Winners of Camstar’s Manufacturing Star Awards for creating top value in their Enterprise Manufacturing Execution System implementations. More information is available at http://usergroups.camstar.com/manufacturing-star-awards/winners .
Cicoil, Valencia CA, the leading manufacturer of flat cables and assemblies, announces its newly expanded website, featuring the company's entire product catalog, complete with part number and keyword searches for all 700+ standard bulk cables and fully terminated assemblies. See www.cicoil.com .
Pentair Equipment Protection, Anoka, MN, a business of Pentair Ltd., is consolidating the company’s McLean-brand product lines under the Hoffman-brand line of cooling products.