Here is the latest batch of news from the medical products community. Please click the link for more.
Regulatory Approvals, Standards, and Launches
K2M Group Holdings, Inc., Leesburg, VA, a global medical device company focused on designing, developing, and commercializing complex spine technologies, techniques, and minimally invasive procedures, has received FDA 510(k) clearance to market its NILE™ Alternative Fixation Spinal System, to address the most complex spinal deformity cases. In addition, K2M received the CE Mark for NILE, to expand the product’s global availability.
Stryker, Mahwah, NJ, a global leader in orthopaedics, medical and surgical, neurotechnology, and spine products, announced that its orthopedics division has received FDA 510(k) clearance for its Mako hip system, which is designed to be compatible with all of Stryker's hip implants, and is launching this tool for its Mako robot-assisted surgery platform.
Zimmer, Warsaw, IN, a leader in joint replacement technology, has announced the release of its XtraFix modular external fixation system which gives trauma surgeons the ability to eliminate surgical steps, and the number of bars and clamps, from external fixation procedures.
Medtronic plc, Dublin, Ireland, a global medical device leader, announced that it has received FDA approval of its CoreValve® System for valve-in-valve procedures in patients whose surgical aortic heart valves have failed. The CoreValve system has also received Japanese regulatory approval. In addition, the Medtronic pump system MiniMed 640G system, designed to imitate the pancreas, has received UK National Health Service approval.
Baxter International Inc., Deerfield, IL, a global, diversified healthcare company, received the CE Mark in Europe for its HOMECHOICE CLARIA, an automated peritoneal dialysis system integrated with the SHARESOURCE web-based connectivity platform.
The FDA has granted a humanitarian device exemption to the first fully implantable fetal micro-pacemaker for prenates. The device, designed by Children’s Hospital Los Angeles and University of Southern California researchers, will see its first human implantation in the near future.
LENSAR, Inc., Orlando, FL, a leader in next-generation femtosecond laser technology for refractive cataract surgery, has received FDA 510k clearance for a suite of five new application technologies integrated into its LENSAR Laser System.
Pilgrim Quality Solutions, Tampa, FL, a global provider of enterprise quality management software and services, has earned certification for ISO 9001:2008 after an extensive audit of the company’s internal operations.
NEC Display Solutions of America, Itasca, IL, a leading provider of commercial LCD display and projector solutions, has received FDA 510(K) market clearance of its MultiSync® MD322C8 LCD, a high resolution display for radiology review applications in healthcare organizations.
Perseon Corporation, Salt Lake City, UT, formerly known as BSD Medical, has won an expanded FDA 510(k) clearance for its MicroThermX device, a soft tissue ablation system. In addition, the company appointed Brian A. Meltzer, MD, as Chief Medical Officer and Vice President of Business Development.
Epoxy Technology Inc., Billerica, MA, a leading manufacturer of high performance specialty epoxy, UV, and hybrid adhesives, has successfully completed ISO 10993 testing on three additional products. This now brings the total number of its biocompatible products to 20, with 9 adhesives having passed the even more stringent testing of ISO 10993.
Leadership News
TRUMPF, Farmington, CT, a world market and technology leader in fabricating machinery and industrial lasers, announced that Stefan Fickenscher has been named Managing Director of TRUMPF Canada. He succeeds Stefan Schreiber who returns to TRUMPF GmbH + Co. KG in Ditzingen, Germany, as head of central sales subsidiaries in the machine tool division.
COR Medical Technologies, Houston, TX, which offers an instant decision support system for rapid and accurate diagnosis, treatment, and follow-up management of patients with diseases involving the cardiovascular system, announced that John Scott was appointed as its Chief Technology Officer. The company has also appointed Dr. Gregg C. Fonarow to its Senior Editorial Board.
NuSil Technology LLC, Carpinteria, CA, a global leader in high purity medical and space-grade silicones, announces the appointment of Ernest Waaser as its new Chief Executive Officer.
Royal Philips, Amsterdam, The Netherlands, announced that Robert Cascella was appointed as Executive Vice President. He will lead the company’s imaging businesses as CEO of the Business Group Diagnostic Imaging. He will be based in Andover, MA, and Amsterdam.
TTE Filters, Los Angeles, CA, a manufacturer of high-reliability RF and microwave filters for communication and signal processing applications and an affiliate of Gowanda Holdings, announced that David Zavac has rejoined the company as Sales Manager.
IMS Health, Danbury, CT, a leading global information and technology services company, announced the appointment of Karen Katen to its Board of Directors.
Nelipak® Healthcare Packaging, Cranston, RI, a global provider of custom thermoformed packaging for medical devices, has appointed Timothy Julian as Vice President of Sales, Americas, and Frits van Gastel as Global Director of Quality.
Signostics Limited, Adelaide, Australia, a device company specializing in in handheld ultrasound devices and bladder scanners, announced the appointment of Kevin Goodwin as the company’s new Chief Executive Officer.
Stimwave Technologies Incorporated, Miami, FL, a medical device company engaged in the development, manufacture, and commercialization of wirelessly powered, injectable, microtechnology neurostimulators, announced the appointment of Dr. Gabor Racz as the chair of its medical advisory board.
Alexandria Industries, Alexandria, MN, which provides aluminum extrusions, precision machining, and plastic injection and foam molding components, as well as finishing, high-level assemblies and welding services, announced that its CEO Tom Schabel has received the Distinguished Service Award from the Aluminum Extruders Council for exceptional dedication and service to the industry.
DJO Global, Inc., Vista, CA, a global provider of medical device solutions for musculoskeletal health, vascular health, and pain management, has appointed Jeanine Kestler as the company's new Executive Vice President and Chief Human Resources Officer.
Pelican Products, Torrance, CA, a global leader in high-impact protective case solutions and advanced portable lighting, has introduced its Lighting solutions sales team for the US market. Led by Vice President of Lighting Sales Mark Rolfes, the team includes Chris Olesen (Northeast Region), Chris Hobbs (Southeast Region), Nick Carlson (Western Region) and Paul Putas (North Midwest Region).
Expansions/Spinoffs/New Services/Moves
COMSOL, Inc., Burlington, MA, the leading provider of multiphysics simulation and analysis software, announced the opening of a new office in Moscow, Russia, to provide sales and support for the growing community of COMSOL Multiphysics® users in Russia.
Teleflex Medical OEM, Gurnee, IL, a global leader in custom-engineered catheters, has added balloon catheter manufacturing technologies to its extensive portfolio of in-house capabilities. New product offerings include non-compliant, semi-compliant, and compliant medical balloons for a variety of peripheral, coronary, and neurovascular applications.
Proto Labs, Inc., Maple Plain, MN, has introduced low-alloy steel to metal injection molding, and added two nickel steel materials (Catamold FN02 and FN0205) and a chrome-moly material (Catamold 42CrMo4), which is the metal injection molding (MIM) equivalent of 4140 steel. The new metals expand the potential applications for parts produced by the company’s advanced MIM process.
Prima Power Laserdyne, Champlin, MN, a world leading manufacturer of multi-axis laser cutting, welding, and drilling systems, has announced plans to install a LASERDYNE 430BD system at its new Prima Power Technology Center in Suzhou, China.
Sensile Medical AG, Haegendorf, Switzerland, a leading provider of advanced micro pump solutions for medical applications, has doubled its capacity and enlarged its staff to accommodate the rapid growth of the company.
Whitford Corporation, Elverson, PA, a longtime manufacturer of fluoropolymer coatings for industrial and consumer industries, has established a new medical coatings group dedicated to supporting the use of its coatings on medical devices. The new medical coatings group will occupy a newly constructed facility that is expected to be fully operational this fall.
Tri-Mack Plastics Manufacturing Corporation, Bristol, RI, a leading manufacturer of high-performance engineered components, has recently hired almost three dozen new employees, opened a new Advanced Composites Center , and is planning to expand its on-site facilities in Bristol. The Advanced Composites Center is dedicated to processing the latest thermoplastic composites
Mergers/Acquisitions/Collaborations/Licensing
Averna, Montreal, Canada, an industry-leading developer of test solutions and services for communications and electronics device-makers worldwide, announced that Tandem Expansion Fund, a leading Canadian growth-equity investor, has acquired a majority interest in the company.
ReliantHeart, Inc., Houston, TX, an innovative supplier of advanced mechanical circulatory assist technologies, and Kollmorgen, Radford, VA, a leading provider of motion systems and components, announced a partnership to produce an energy efficient motor stator designed to cut the power consumption of the HeartAssist5® Left Ventricular Assist Device by 50 percent.
DePuy Synthes Companies, Warsaw, IN, a leader in joint reconstruction, has signed an exclusive worldwide sales agreement with Radlink, Inc., El Segundo, CA, an emerging leader in advanced medical imaging technology, to offer real-time image guidance with its hip replacement systems. The agreement provides DePuy Synthes Companies with exclusive rights to market the Radlink Galileo Positioning System™ for use with DePuy Synthes Companies’ hip replacement systems.
GreenPeak Technologies, Utrecht, The Netherlands, an industry-leading Smart Home semi-conductor/system company, and ZTE Health, Shanghai, China, a member of the ZTE Group, which offers enhanced products and services in the telecommunication area to its customers. have signed a partnership agreement to develop and provide a Smart Senior Lifestyle monitoring solution to telecom operators and local governments worldwide to enable an aging population to live longer at home independently.
ExOne Company, North Huntingdon, PA, a global provider of 3D printing machines and printed products, announced the appointment of two new independent sales representatives in Israel and Thailand for ExOne's complete product portfolio. 3Deimention will be an independent sales representative for the Israeli market and Speed 3D Mold Co. Ltd., is the independent sales representative in Thailand.
Orthofix International N.V., Lewisville, TX, a diversified, global medical device company, has entered into an agreement with an 18-month option to acquire eNeura, Inc., Baltimore, MD, a pioneer in the use of portable, non-invasive transcranial magnetic stimulation devices.
Hitachi Aloka Medical, Ltd., Tokyo, Japan, and iVu Imaging Corporation, Dallas, TX, announced the signing of an agreement making Hitachi Aloka Medical, Ltd. the exclusive global distributor of iVu’s SOFIA system, an automated whole breast ultrasound scanner designed to detect cancer in women with dense breasts.
Boston Scientific Corporation, Marlborough, MA, a global medical technology leader, has signed a definitive agreement to acquire Xlumena, Inc., Mountainview, CA, a venture-backed medical device company that develops, manufactures, and sells minimally invasive devices for endoscopic ultrasound-guided transluminal drainage within the gastrointestinal tract.
DreaMed Diabetes, Petah Tikva, Israel, a developer of diabetes treatment and management solutions, has signed an exclusive worldwide development and license agreement with Medtronic plc, Dublin, Ireland, the world’s premier medical technology and services company, for the development and marketing of products incorporating DreaMed’s MD-Logic Artificial Pancreas algorithm in Medtronic’s insulin pumps.
Integro Technologies, Salisbury, NC, a leading machine vision company, announces its partnership agreement with Mitsubishi Electric Automation, Inc., Vernon Hills, IL, a leader in machine vision components. This agreement appoints Integro Technologies as the distribution channel for Mitsubishi Electric’s Contact Image Sensors KD Series Series.
Foster Polymer Distribution, Putnam, CT, specializing in the distribution of medical polymers and additives, announces its official partnership with Mitsubishi Gas Chemical to distribute MX-Nylon, a meta-xylene diamine polyamide, to the North American medical market.
Miscellaneous
Clippard Instrument Laboratory, Cincinnati, OH, a world leader in manufacturing miniature pneumatic components and devices, is expanding its website hours of operation to 24 hours a day, 7 days a week. See http://www.clippard.com/link/othr1709025 .
The FDA and the Biomedical Engineering Society, Landover, MD, will host a joint conference, Frontiers in Medical Devices, to be held May 18-20 in Washington, DC. For more information, visit http://bmes.org/meddevicesconference .
GW Plastics, Bethel, VT, a leader in precision injection molding and contract manufacturing, is also a leader in workforce training, career development, and community educational outreach, This year, it began a “School of Tech”, where local high school students are bused to the company’s facilities for a semester-long course focused on manufacturing technology. In addition, the company funds a scholarship and internship program with Vermont Technical College.
