Here is the latest batch of news from the medical products community. Please click the link for more.
Regulatory Approval
Boston Scientific Corporation, Natick, MA, received FDA 510(k) clearance and CE Mark approval for its Guidezilla™ Guide Extension Catheter and has launched the device in the US and Europe. The device is designed to make complex percutaneous coronary intervention procedures easier by more efficiently delivering interventional devices. In addition, the company received FDA 510(k) clearance for the Rhythmia™ Mapping System, a next-generation 3D mapping and navigation solution for use in cardiac catheter ablations and other electrophysiology procedures.
Abbott, Abbott Park, IL, has received FDA clearance for its FreeStyle Precision Pro Blood Glucose and β-Ketone Monitoring System™, an advanced blood glucose monitoring system designed to address the needs of hospital customers.
Given Imaging Ltd., Yoqneam, Israel, announced that Japan’s Pharmaceuticals & Medical Devices Agency has cleared the company's PillCam Colon endoscopic capsule for diagnosis of colonic disease when colonoscopy is required but difficult to conduct.
CryoLife, Inc., Kennesaw, GA, a leading tissue processing and medical device company focused on cardiac and vascular surgery, announced that it has received FDA premarket approval for its new Sologrip® minimally invasive laser fiber-optic delivery system.
CUI Inc., Tualatin, OR, announced that its range of medical power supplies has received IEC 60601-1 3rd edition medical safety certifications for both the US and Europe.
Polymer Technology Systems, Inc., Indianapolis, IN, the U.S.-based manufacturer of the CardioChek® family of point-of-care diagnostic products, has announced the issuance of two new U.S. patents: one relates to the management of health data collected by point-of-care testing devices, and the other covers a method and apparatus for manufacturing disposable dry test strips.
NEBA Health, Augusta, GA, announced that its Neuropsychiatric EEG-Based Assessment Aid (NEBA) System, the first medical device based on brain function to help assess attention-deficit/hyperactivity disorder in children and adolescents 6 to 17 years old, has been approved by the FDA.
Bacterin International Holdings, Inc., Belgrade, MT, which develops bone graft material and coatings for medical applications, has obtained FDA 510(k) approval to market OsteoSelect® DBM Putty for use in spinal fusion procedures.
Tecsis LP, Worthington, OH, has attained ISO 9001:2008 certification, which ensures that it operates a quality management system for the design and manufacturing of load and pressure transducers.
Royal Philips, Andover, MA, has received 510(k) clearance from the FDA for its AlluraClarity live image guidance system in the US, following its introduction in countries outside the US in 2012.
GE Healthcare, Little Chalfont, UK, received the CE Mark for its SenoClaire 3D breast imaging system, which the company says exposes women to less radiation during breast cancer screening.
ON Semiconductor, Phoenix, AZ, announced that its Burlington, Canada, advanced packaging facility has received ISO 13485:2003 certification, the international quality management system standard for the design and manufacture of medical devices.
Invacare Corporation, Elyria, OH, announced that the FDA has found acceptable the company’s second third-party certification audit relating to design control systems at its Corporate and Taylor Street facilities, which permits Invacare to resume design activities for power wheelchairs and power beds.
Topcon Medical Laser Systems, Santa Clara, CA, has received 510(k) clearance from the FDA for its portable, dual-port, pattern-scanning laser, the Pascal Synthesis, which can allow fast and effective treatment of retinal disorders.
Tenex Health Inc., Lake Forest, CA, has received the CE Mark for its TX System, a minimally invasive treatment for tendon pain.
Sintea Plustek S.r.l. , Milan, Italy, a leading supplier of minimally invasive spinal implants and delivery systems, has earned the CE Mark and launched in Italy and throughout Europe the new DOMINO cervical fusion cage implant made of Zeniva® polyetheretherketone (PEEK) resin from Solvay Specialty Polymers.
Leadership News
Nitinol Devices & Components, Fremont, CA, a contract manufacturer of Nitinol-based medical devices, announced the appointment of Dean Schauer as its President and CEO, effective September 1, 2013. He will also join the company’s board of directors.
Teleflex Incorporated, Limerick, PA, announced the promotion of Gwen Watanabe as Vice President – Business Development and Technical Resources. She was a founding leader in four successful medical device start-ups, including: AneuRx, Bacchus Vascular, Nellix Endovascular, and Hotspur Technologies.
Toshiba America Medical Systems, Inc., Tustin, CA, has named David Sloop as director, X-ray Vascular Business Unit. He will be responsible for implementing strategic marketing plans to drive growth and profitability of Toshiba’s X-ray Vascular product line.
Samsung Electronics America Inc., Ridgefield Park, NJ, a subsidiary of Samsung Electronics Co., Ltd, today announced the appointment of Doug Ryan as Group Vice President for Health and Medical Equipment (HME) within its Enterprise Business Division.
Honeywell, Morris Township, NJ, announced that Chief Executive Magazine named Chairman and CEO Dave Cote “2013 CEO of the Year,” an honor that recognizes an outstanding corporate leader nominated and selected by peers.
Welch Allyn, Skaneateles Falls, NY, announced that Vincent C. Caponi, currently the Executive Chairman of the Board at St. Vincent Health and a Senior Vice President at Ascension, has been elected to its board of directors.
Precision Polymer Engineering, Blackburn, UK, one of the world’s leading manufacturers of high performance molded elastomer seals has appointed Jamie Hill as Regional OEM Sales Manager for the UK.
Hany Demian, senior biomedical engineer at the Center for Devices and Radiological Health, Office of Device Evaluation, at the U.S. Food and Drug Administration in Silver Spring, MD, has received the Patrick G. Laing Award from ASTM International for his outstanding contributions in the medical and surgical devices field. The Laing Award is Committee F04’s highest-level award.
Expansions/Moves
Intertek, London, UK, a leading quality solutions provider to industries worldwide, announced the launch of a centralized Chemical Testing SuperCenter in Arlington Heights, IL. The SuperCenter offers chemical testing to ensure product compliance to regulations including EU’s Restriction of Hazardous Substances (RoHS and RoHS2), Registration, Evaluation, Authorization and Restriction of Chemical substances (REACH) and in the US, the Consumer Product Safety Improvement Act (CPSIA), state regulations, and more..
Raumedic AG has announced that it is investing in a new building with cleanroom production and manufacturing capabilities as well as laboratory and office space at its headquarters in the Bavarian town of Helmbrechts.
Isola Group S.a.r.l., Chandler, AZ, a leader in laminate materials used to fabricate multi-layer printed circuit boards, announced the site expansion of its Suzhou, China manufacturing facility. The substantial upgrade includes two additional hot oil presses, semi-automatic layup lines and an additional cleanroom.
LDRA, Wirral, UK, a leading provider of automated software verification, source code analysis, and test tools, celebrates three years of growth by its Bangalore, India, office and plans to open additional offices in Delhi and Hyderabad, India this year.
Performance Machinery LLC, Grand Rapids, MI, a Midwest regional distributor of Mitsubishi EDM, Wood Dale, IL, milling and waterjet machine technologies, expanded its coverage footprint this month to include the entirety of the lower peninsula of Michigan. Performance Machinery had serviced only the Eastern portion of the state.
SIMTEC Silicone Parts, a custom manufacturer of Liquid Silicone Rubber parts and high-precision two-shot components announces its corporate relocation to a state-of-the-art, custom-built manufacturing facility in Miramar, Florida. The company was previously headquartered in Madison, Wisconsin.
Wright Engineered Plastics, Santa Rosa, CA, is doubling the size of its production facility and adding 100 workers to accommodate greater demand for injection molding of parts as well as assembly of products in the US.
ATW Companies Inc., Warwick, RI, a leading provider of custom manufactured metal components and services, announced that its Judson A. Smith subsidiary, Boyertown, PA, has expanded its market share in the US endoscopic laparoscopic device market with ISO 13485 certification to meet medical device quality standards.
Igus Inc., East Providence, RI, is continuing its growth trend. Within the context of a long-term investment program, significant capital will be directed at new product divisions, the expansion of existing product lines as well as global logistics and production. There is an expanded team of industry specialists providing support to sales engineers in the fields of machine tools, packaging machines, material handling, medical technology, and robotics. In addition, this year, the company moved into new facilities in South Korea and Brazil.
Mergers/Acquisitions/Collaborations
Phillips-Medisize Corporation, Hudson, WI, announced that it has entered into a definitive agreement with the Adval Tech Group to purchase two manufacturing operations in Suzhou, China (Adval Tech Medical (Suzhou) Co. Ltd.) and Queretaro, Mexico (Omni Manufacturing Services S.A. de C. V.). This will position Phillips-Medisize to begin servicing its global customer base from these locations immediately.
Abbott Laboratories, Abbott Park, IL, announced two acquisitions today, saying it would buy two medical device firms, one focused on cataract surgery and one aimed at making devices for interventional radiologists, vascular surgeons, and cardiologists. The purchases of OptiMedica, Sunnyvale, CA, and privately held IDEV Technologies, Webster, TX, are expected to close by year end.
Zecotek Photonics Inc., Richmond, BC, Canada, a developer of leading-edge photonics technologies for medical, industrial, and scientific markets, announced that its wholly owned subsidiary Zecotek Imaging Systems Pte. Ltd., Singapore, has signed a joint collaboration partnership agreement with Hamamatsu Photonics, Tokyo, Japan, to commercialize existing imaging technologies and to collaborate on the upgrade and manufacture of photo detectors, integrated detector modules, and associated electronics and data acquisition modules for the imaging markets at large.
Advanced Circulatory, Roseville, MN, a manufacturer of multiple medical devices and the pioneer of Perfusion on Demand™ therapy, has selected Combat Medical Systems, Fayetteville, NC, as its US distributor for the military and federal market space.
RTI Biologics Inc., Alachua, FL, a provider of orthopedic and other biologic implants, announced that it has completed the acquisition of Pioneer Surgical Technology, Marquette, MI. Effective immediately, the new name of the company is RTI Surgical Inc.
ZOLL Medical Corporation, Chelmsford, MA, a manufacturer of medical devices and related software solutions, has purchased the assets of LIFEBRIDGE® Medizintechnik AG, Ampfing, Germany, a provider of medical devices for emergency use that provide circulatory support and extracorporeal oxygenation to patients in acute circulatory or respiratory failure.
Elekta, Milwaukee, WI, and Royal Philips, Andover, MA, announced that the Froedtert & Medical College of Wisconsin Clinical Cancer Center, Milwaukee, WI, will join a consortium that is investigating the development of a magnetic resonance imaging-guided radiation therapy system.
BitFlow, Woburn, MA, a leading manufacturer of frame grabbers for machine and medical imaging, announced that its Neon-CLB PCIe frame grabber is a key component of the 3D structured-light imaging system deployed in the Robomotive™ humanoid robot, jointly developed by Yaskawa Motoman, Beltech and Robotiq.
Mindray Medical International Ltd., Shenzhen, China, has closed on its acquisition of ultrasound technology company Zonare Medical Systems Inc., MountainView, CA.
Intertech Plastics Inc., Denver, CO, has acquired Image Molding, also Denver, a provider of injection molding and contract manufacturing services to the medical devices industry.
Mack Molding, Arlington, VT, a leading custom plastics molder and supplier of contract manufacturing services, has acquired Synectic Engineering, Inc., Milford, CT, a medical product development company employing mechanical, electrical, biomedical, materials, chemical and quality engineers, clinicians, and industrial designers.
Mouser Electronics, Inc., Mansfield, TX, has signed a global agreement with Intel Corporation, Santa Clara, CA, creator of the microprocessor, to provide engineers with direct access to Intel’s entire portfolio of mobile, desktop, and server products.
Illumina, Inc., San Diego, CA, has acquired Advanced Liquid Logic, Morrisville, NC, a leading provider of liquid handling solutions.
Miscellaneous
Oss-Q AB, Stockholm, Sweden, initiating a clinical trial with OssDsign Cranio PSI, its implant for skull reconstruction, will change its name to OssDsign AB.
PRO-DEX, INC., Irvine, CA, a leading medical device developer and manufacturer of world-class powered surgical devices, has partnered with UC Irvine's The Henry Samueli School of Engineering to offer graduating seniors the opportunity to work alongside industry veterans in the design and manufacture of next-generation medical devices.
Fiberesin Industries Inc., Oconomowoc, WI, a leading value-add manufacturer of custom engineered components, materials, and finished goods serving the medical devices industry has received the 2013 Steelcase Inc. Premier Supplier Award.
Global Good, Bellevue, WA, and leading refrigeration company AUCMA, Qingdao, China, announced an agreement to commercialize Global Good's vaccine storage invention for use in developing countries. Under the agreement, AUCMA will manufacture and distribute the device to help strengthen the vaccine supply chain in underserved regions. The agreement marks the first commercialization deal for Global Good, which is a collaboration between Intellectual Ventures (IV) and Bill Gates to invent technology that improves life in developing countries.
University College Dublin, Ireland, has taken the idea of a university incubator in a new direction, opening up a space specifically designed to house staff from technology companies that are commercializing UCD’s research. While it’s not uncommon for universities and industry to work together, the dedicated space for this purpose may be a first.
FloMet LLC/A QMT Company, Deland, FL, was awarded the grand prize in the medical/dental category of the 2013 Powder Metallurgy Design Excellence Awards Competition, sponsored by the Metal Powder Industries Federation, for a 17-4 PH stainless steel jaw made via metal injection molding for US Endoscopy, Mentor, OH, and used in a Raptor™ grasping device. Polymer Technology Inc., Clifton, NJ, received the award of distinction in the medical/dental category for a stainless steel shuttle used in a “smart” stapling device for both open and minimally invasive arthroscopic surgery.
ITI TranscenData, Milford, OH, a leading CAD data interoperability supplier, announced the release of a new German language web site, www.transcendata.de, to support demand for interoperability and OEM compliance solutions in Germany.
The ExOne Company, North Huntingdon, PA, a global provider of three-dimensional printing machines and printed products to industrial customers, has added iron infiltrated with bronze as a new 3D printing material and has increased its suite of binder solutions for its 3D printing process.
OMAX Corporation, Kent, WA, is celebrating 20 years of continuous innovation in abrasive waterjet technology with a special event at its campus in Kent, Wash. on Aug. 20, 2013. The event will feature the latest advancements in waterjet machining as well as technical sessions, live cutting demonstrations and tours of the company’s recently expanded manufacturing factory.
Colder Products Company, St. Paul, MN, with a product portfolio of more than 10,500 different connection solutions that include couplings and fittings, is marking its 35th anniversary this month. Since introducing the first all-plastic quick disconnect couplings to the market, Colder has produced a number of other firsts, including introducing the first connectors molded in polycarbonate and polysulfone; IdentiQuik® Smart Couplings that incorporate radio frequency identification to help track, protect, and streamline valuable fluids; hybrid connectors that enable the flow of electrical signals as well as liquids and gases; and the world’s smallest non-spill plastic disconnect for tubing as small as 1 mm OD.
