Here is the latest batch of news from the medical products community. Please click the link for more.
Regulatory Approvals, Standards, and Launches
Blue Belt Technologies, Inc., Plymouth, MN, which specializes in solutions for orthopedic surgery, has received the CE Mark for its STRIDE™ Unicondylar Knee System.
Amsel Medical Corporation, Cambridge, MA, a development stage medical device company, has received FDA 510(k) approval for its Amsel Occluder Deviceto be used on tubular structures or blood vessels.
Advanced Bionics, Valencia, CA, a global leader in cochlear implant technology, has received CE Mark approval from the European Notified Body, TÜV, for its HiRes 90K™ and HiRes 90K™ Advantage cochlear implants to undergo 1.5T MRI scans without removing the internal magnet.
Distal Access™, Salt Lake City, UT, which creates guidewire and catheter controllers, announced that it has received FDA clearance for its SPINR High-Performance Guidewire Controller™ for use in coronary and peripheral vasculature.
Koning Corporation, Rochester, NY, a medical imaging systems maker, announced that the FDA has approved its 3D Koning Breast CT imaging system and KBCT-guided biopsy bracket, first 3D breast CT scanner commercially available in the US that images the entire breast with a single scan.
Titan Spine, Mequon, WI, a medical device surface technology company focused on developing innovative spinal interbody fusion implants, has received FDA 510(k) clearance to release its Endoskeleton® TCS, an interbody fusion device for the cervical spine with integrated fixation.
Vital Connect, San Jose, CA, has received the Medical Device Ninsho certification to market its HealthPatch® MD as a telemetric electrocardiography transmission device and body movement sensor in Japan.
Leadership News
Laurimed LLC, Redwood City, CA, which created the PolypVac Microdebrider device to treat nasal polyps, announced the appointment of Richard M. Ferrari as Chief Executive Officer.
Mazor Robotics Ltd., Caesarea, Israel, a developer of innovative guidance systems and complementary products, announced that Sandra Adzic has been named Vice President of International Sales responsible for sales strategy in Asia and Europe.
COR Medical Technologies, Houston, TX, which offers CORcare™, a comprehensive instant decision support system for rapid and accurate diagnosis, treatment, and follow-up management of patients with acute and chronic diseases involving the cardiovascular system, has appointed Dr. Robert Roberts to its Senior Editorial Board.
Intelligrated®, St. Louis, MO, a leading automated material handling solutions provider, announces that Earl Wohlrab, its robotic and palletizing systems product manager, has been elected to the Robotic Industries Association Board of Directors.
Noxilizer Inc., Baltimore, MD, which provides room-temperature nitrogen dioxide sterilization technology, announced that Herbert C. Buchanan, Jr., President of the Indiana University Health Methodist and University Hospitals has joined Noxilizer’s Board of Directors.
Expansions/Spinoffs/New Services/Moves
Teleflex Medical OEM, Gurnee, IL, a global leader in medical suture and fiber technology, announces a significant expansion of its manufacturing infrastructure and production capabilities for bioresorbable sutures, fibers, and resins. The multi-million dollar investment at the Mansfield, MA, facility includes expanded production and clean room areas, a new customer support center, and additional areas for R&D activities.
PTI Engineered Plastics, Macomb, MI, expands its services into into additive manufacturing/3D with the procurement of a Lumex Avance-25, currently the only machine in the world able to manufacture complex molds and parts by direct metal laser sintering without the need for secondary finishing processes. PTI will utilize the Lumex hybrid technology of additive manufacturing plus high-speed milling to grow high-precision finished mold inserts.
Shin-Etsu Chemical Co. Ltd., the largest chemical company in Japan manufacturing silicone products worldwide, and producing more than 4,000 different silicone products, announces that its US subsidiary, Shin-Etsu Silicones of America, Inc., recently opened a new, 7,020 square footstate-of-the-art LIMS™ (Liquid Injection Molding System) Technical Center in Akron, OH. The plant will be under the leadership of Shin-Etsu’s LIMS Process Engineer Craig Lustek.
Saki Corporation, Tokyo, Japan, an innovator in the field of automated optical inspection equipment, has expanded its operations in the Americas. Saki America, San Jose, CA, has signed an agreement with Lean Stream LLC, San Jose, CA, to be its representative for the western United States. In addition, Satoshi (John) Otake, Deputy General Manager, will head up operations for Saki America and Quintin Armstrong was hired as General Manager for North America sales and service, based out of Florida.
GW Plastics, Bethel, VT, has purchased two high-speed injection molding machines to further expand its capabilities in the high-volume disposable medical device market. This follows its multimillion-dollar expansions in its Tucson, AZ, and Dongguan, China, facilities to support its growing medical device molding and contract assembly business.
Vention Medical, Marlborough, MA, a global integrated solutions partner for design, engineering, and manufacturing of complex medical devices and components, has expanded its catheter capabilities in Costa Rica to create a Catheter Center of Excellence.
Mergers/Acquisitions/Collaborations/Licensing
Dinamec Systems, LLC, Acworth, GA, a leading manufacturer of gas-heated fluidized sand beds for removing organic substances such as paint, powder coating, and rubber from most all metal alloys, became the exclusive distributor for North America of SCHWING Fluid Technik GmbH, Neukirchen-Vluyn, Germany, a leading design engineer, manufacturer, and operator of electric heated fluidized bed systems as well as vacuum furnaces for premium thermal cleaning processes in the plastics and fiber industry.
Mouser Electronics, Inc., Mansfield, TX, the global authorized distributor with the newest semiconductors and electronic components, has reached a distribution agreement with Digilent Inc., Pullman, WA, a subsidiary of National Instruments, and a leading engineering design company.
DePuy Synthes Companies, Raynham, MA, a global innovator of most comprehensive orthopaedic and neurological solutions, announced that it has acquired Olive Medical Corporation, Salt Lake City, UT, a provider of high definition visualization systems for minimally invasive surgery.
Fabrico Medical, Rochester, NY, a provider of converted materials and advanced assembly for the design-to-manufacture of medical devices and disposables, announced a manufacturer’s representative sales agreement with Peterson Enterprises, Minneapolis, MN, a leader in sourcing engineered components for medical devices.
Bunting® Magnetics Company, Newton, KS, a producer of precision magnetic products for the worldwide plastics, food, recycling, printing, automobile, and electronics industries, has named Ventura Process Equipment Company, Saint Simons Island, GA, as its representative for Latin America.
Miscellaneous
Santa Barbara Infrared, Inc., Santa Barbara, CA, a manufacturer of advanced electro-optic test equipment, announces its new website including updated product listings and more at www.sbir.com .
SCHURTER, Inc., Santa Rosa, CA, a manufacturer of circuit protection, connectors, switches, and EMC products, announces its newly translated Chinese website for the Asia market. Visit it at http://www.schurter.cn/ .
Morgan Advanced Materials, Windsor, UK, a global materials engineering company, has expanded its capabilities for designing and manufacturing ceramic pockets, ideal for housing medical device electronics.
Neuro Resource Group, Inc., Plano, TX, has received a patent for its self-directing, transcutaneous stimulation electrode, which provides a unique design consisting of alternating electrodes of both positive and negative polarities.
