Here is the latest batch of news from the medical products community. Please click the link for more.
Regulatory Approval
St. Jude Medical, Inc., St. Paul, MN, a global medical device company, announced CE Mark approval of its next-generation EnligHTN™ Renal Denervation System to treat patients with drug-resistant, uncontrolled hypertension.
Avinger, Inc., Redwood City, CA, a designer of therapeutic devices incorporating intravascular imaging, has received CE Mark approval for Pantheris, a system that combines directional atherectomy capabilities with real-time intravascular visualization to remove plaque from blocked arteries.
SpineGuard, San Francisco, CA, has received FDA 510(k) clearance of three new products that complete its PediGuard platform of single-use drilling instruments which secure the pedicle screw pilot hole: two miniaturized versions of its classic and curved range, and a directional version of its cannulated series. The company has also received product certification ("Ninsho") to market its products in Japan.
BIOTRONIK, Berlin, Germany, a leading manufacturer of cardiovascular technology, today announced an extension of its ProMRI® technology. BIOTRONIK has combined advanced pacemaker and ICD technology with the option for patients to undergo MR scans. This makes BIOTRONIK the only company worldwide to allow ICD and heart failure patients to take MR scans.
Tissue Regeneration Systems, Inc., Ann Arbor, MI, has received FDA 510(k) approval for its Cranial Bone Void Filler product, a coated bioresorbable skeletal reconstruction implant fabricated by means of 3D printing to repair neurosurgical burr holes.
Okay Industries, New Britain, CT, earned ISO 13485 registration for both its New Britain and Berlin, CT, facilities, as well as achieving ISO 9000-2008 for its Alajuela, Costa Rica location.
Wenzel Spine, Inc., Austin, TX, a medical device company focused on providing minimally invasive, stand-alone alternatives to traditional spinal fusion, has been granted a new patent related to its Spine’s Zero-Profile VariLift® Stand-Alone Expandable Interbody Fusion System.
FUJIFILM SonoSite, Inc., Bothell, WA, specialists in designing cutting-edge ultrasound tools and world-leading education for access to point-of-care visualization, announced CE mark approval for its newest generation of point-of-care ultrasound: the X-Porte™ Ultrasound Kiosk. SonoSite will begin shipping the X-Porte kiosk effective immediately.
Stelkast, McMurray, PA, designer, manufacturer, and distributor of a full line of quality orthopedic implants for knee and hip replacement, received FDA 510(k) clearance to market EXp™ for the Proven Gen-Flex™ Total Knee System.
Leadership News
Nitinol Devices & Components, Inc., Fremont, CA, announced the appointment of Dan Lemaitre to its Board of Directors. He is the current CEO of White Pine Medical and recently served as CEO of CoreValve until its acquisition by Medtronic.
Gefran Inc., Winchester, MA, a global manufacturer of industrial automation solutions, announced that Ruben R. Salinas has been named North America Sales Manager, Drives and Motion Control Products.
Devon Medical, Inc., King of Prussia, PA, a global medical device manufacturer and creator of the extriCARE® portable Negative Pressure Wound Therapy System, has announced Chip Ross as its new president. He brings more than 20 years of experience in the wound care and medical device arenas.
AtriCure, Inc., West Chester, OH, a medical device company and a leader in the development of technologies and solutions to treat atrial fibrillation, announced that Scott Drake, Chief Executive Officer of the Spectranetics Corporation, has been elected to its Board of Directors.
IPG, Alpharetta GA, a leading provider of Implantable Device Benefit Management™ solutions, appointed Steve Janicak as the executive vice president of sales & marketing.
Expansions/Moves
Medtronic, Inc., Minneapolis, MN, announced the formation of Medtronic Hospital Solutions, a new business focused on developing novel partnerships with hospitals to provide services directly related to hospital operational efficiency. The new business will focus initially on offering services in Europe to manage and modernize catheterization laboratory facilities.
Mouser Electronics, Inc., Mansfield, TX, a leading engineering resource and a global distributor of semiconductors and electronic components, today announced the new opening of a customer service center situated in Penang, Malaysia. This new office now makes 20 locations worldwide.
Mergers/Acquisitions/Collaborations
Phillips-Medisize Corporation, Hudson, WI, completed its purchase of two manufacturing operations in Suzhou, China (Adval Tech Medical (Suzhou) Co. Ltd.) and Queretaro, Mexico (Omni Manufacturing Services S.A. de C. V.) from The Adval Tech Group. By acquiring existing operational facilities, this expands Phillips-Medisize’s global footprint, while allowing the company to immediately service its global customer base from these two new locations. The China facility is both ISO 9001 and 13485 compliant and SFDA certified to manufacture finished drug delivery systems and related medical devices. The Mexico facility is both ISO 9001 and 13485 compliant, and FDA registered to manufacture components and subassemblies, drug delivery systems and other related medical devices.
C.R. Bard, Inc., Murray Hill, NJ, has entered into a definitive agreement to acquire Rochester Medical, Inc., Stewartville, MN, a leading developer and supplier of silicone urinary incontinence and urine drainage products. This transaction is structured as a merger.
Pexco LLC, Atlanta, GA, a leading North American specialty plastics processor, has acquired the Minneapolis, MN-based operation of Spectrum Plastics, Inc. Spectrum Minnesota is a precision injection molder of advanced thermoplastics selling primarily into the medical and surgical, defense, and aerospace fields.
Baxter International Inc., Deerfield, IL, has successfully completed the acquisition of Gambro AB, Lund, Sweden, a privately held global medical technology company and leader in dialysis products.
Machine Solutions Inc., Flagstaff, AZ, which specialized in automating manual processes within catheter and stent manufacturing operations, has acquired Vante Inc., Tucson, AZ, which designs, develops, and manufactures process systems for the disposable medical device and biopharmaceutical industries.
Miscellaneous
Applied Silicone Corporation, Santa Paula, CA, a global supplier of implantable silicone material, announces the availability of material compendia detailing the physical, chemical, and biological testing of the raw material specific to each long-term implantable silicone product offered by the company. This provides the user with an extensive summary of the supporting documentation available, in electronic format, for regulatory review and submissions for Class II and Class III medical devices. To learn more about Applied Silicone’s products and services and to preview a sample compendium index please visit, www.appliedsilicone.com
Mazak Corporation, Florence, KY, a leader in the design and manufacture of productivity-improving machine tool solutions, recently launched a new North American website located at http://www.MazakUSA.com . MazakUSA.com features unprecedented amounts of company, product, and applications information, as well as unique functionality and highly interactive tools for manufacturers. Mazak also recently named SIM Technologies Corporation, Batavia, OH, an engineering services firm specializing in software development for the manufacturing and distribution industries, to its exclusive Value Inspired Partner technology program that brings total manufacturing solutions to Mazak customers.
Inc. magazine ranked FATHOM™, Oakland, CA, the nation’s fastest-growing 3D printing and rapid prototype production center and top performing Stratasys 3D printer distributor of Northern California and Pacific Northwest, No. 369 on its 32nd annual Inc. 500|5000, an exclusive ranking of the most rapidly expanding private companies in the United States.
Seco Tools, Troy, MI, has been named to Corp! magazine’s list of “Michigan’s Best and Brightest Sustainable Companies” for 2013. The honor reflects Seco’s active efforts to support sustainability and minimize its impact on the environment, as well as community outreach efforts.
Teleflex Medical OEM, Gurnee, IL, is presenting a free webinar, “Optimal Catheter Design: Making the Smart Choices When Selecting Materials and Manufacturing Processes” on Thursday, September 26, 2013 at 2:00 PM ET (1:00 PM CT, 11:00 AM PT). This presentation will help participants choose materials and production processes to achieve cost and performance objectives of a catheter-based project. http://www.teleflexmedicaloem.com
Lumen Dynamics, Mississauga, Canada, a world leader in light delivery technologies, is very excited to announce the launch of its new website at www.ldgi.com .
