Here is the latest batch of news from the medical products community. Please click the link for more.
Regulatory Approvals, Standards, and Launches
Colibri Heart Valve, LLC, Broomfield, CO, which is developing novel heart valve technologies, has received a patent for controlled release of a percutaneous replacement heart valve device.
Siemens Medical Solutions USA, Inc., Malvern, PA, a leading provider of medical imaging equipment, announced that the FDA has approved its MAMMOMAT Inspiration with Tomosynthesis Option, the breast tomosynthesis add-on option for Siemens Healthcare’s MAMMOMAT Inspiration digital mammography platform.
ivWatch, LLC, Williamsburg, VA, which develops medical devices that aid in the early detection of intravenous infiltration and extravasation events, reports that its Model 400 device has received FDA 510(k) clearance, and plans to launch the product this fall.
CardiacAssist, Inc., Pittsburgh, PA, has received a Class 3 CE Mark for its new PROTEK DuoTM veno-venous cannula, licensed for use as a single cannula for both venous drainage and reinfusion of blood during life support procedures.
Hansen Medical, Inc., Mountain View, CA, a leader in intravascular robotics, reports that its 10-French Magellan robot-assisted catheter for peripheral artery disease treatment has received CE Mark approval.
BIOTRONIK, Lake Oswego, OR, a leading manufacturer of cardiovascular medical technology, announced that the FDA has approved two of its implantable cardioverter defibrillators designed to deliver an ultra-high-energy initial shock. Biotronik said the approval for its Inventra DX also covers its Itrevia DX defibrillators.
Cardiovascular Systems, Inc., St. Paul, MN, which focuses on treating vascular and coronary disease, has received FDA clearance for its new 4 French 1.25 Solid Diamondback 360® Peripheral Orbital Atherectomy System to treat peripheral artery disease.
Alycone Lifesciences, Lowell, MA, announced that its MEMS Cannula, a neuro-ventricular device for central nervous system disorders, has won FDA 510(k) clearance.
Natus Medical Incorporated, Pleasanton, CA, has received FDA 510(k) clearance for its Quantum amplifier, an innovative high channel count amplifier with applications in epilepsy and seizure monitoring.
Nipro Diagnostics, Inc., Fort Lauderdale, FL, a leading developer, manufacturer, and marketer of advanced performance products for people with diabetes, announced that its True Metrix Air self-monitoring blood glucose system, which can wirelessly deliver data to a smartphone, has received FDA 510(k) clearance.
Codman Neuro, a part of the DePuy Synthes Companies of Johnson & Johnson, Raynham, MA, which develops a wide range of diagnostic and therapeutic products to treat neurological and neurovascular disorders, has launched the CODMAN ENTERPRISE® 2 Vascular Reconstruction Device in Europe, the latest generation of the company’s self-expanding stent and delivery system used to treat intracranial aneurysms and to maintain the position of endovascular coils.
STENTYS, Paris, France, and Princeton, NJ, a medical technology company developing and commercializing solutions to treat complex artery disease, has received the CE Mark for its new Self-Apposing stent system. STENTYS will officially launch Xposition S™ in May.
Leadership News
Albright Technologies, Leominster, MA, a leading provider of silicone prototyping and low-volume production molding solutions, announced a restructuring of it organization. Matthew Bont has been promoted to Director of Operations. Ryan Taylor has been promoted to Director of Sales and Marketing. The company also announced the launch of its new website at www.albright1.com .
PENTAX Medical, Montvale, NJ, a division of Hoya Group and a leader in endoscopic imaging, announced that Mark Koppel, MD, will join the organization as Chief Medical Officer of the Americas. In addition, Gene Merante has been appointed Chief Operating Officer of the Americas, in addition to his current role as Chief Financial Officer of the Americas.
Tegra Medical, Franklin, MA, which provides precision machining and contract manufacturing services to the medical device industry, announced that Craig Campbell has joined the company as Chief Financial Officer.
Nihon Kohden, Irvine, CA, a leader in patient monitoring, sleep assessment, neurology and cardiology instrumentation solutions, has appointed Dr. Wilson P. Constantine the new Chief Executive Officer of Nihon Kohden America.
IlluminOss Medical, East Providence, RI, a commercial stage medical device company focused on minimally invasive orthopedic fracture repair, announced the appointment of Amy Orlick Berman as the company’s Vice President of Clinical Affairs.
Bunting® Magnetics Co., Newton, KS, which develops and manufactures precision magnetic products, announced that Rod Henricks, Director of Sales, has been named to the Board of Directors of the Process Equipment Manufacturers Association (PEMA®).
Pelican Products, Inc., Torrance, CA, which designs and manufactures high-performance protective cases and portable lighting systems, has appointed Dave Williams as President of its Pelican BioThermal™ Division.
Nephros, Inc., River Edge, NJ, a commercial stage medical device company that develops liquid purification ultrafilters and a hemodiafiltration system for use with a hemodialysis machine, announced that Daron Evans has been appointed President and Chief Executive Officer.
Acelleron Medical Products, Guilford, CT, a durable medical equipment company, has hired Jan Ferraro as Director of Education.
Toshiba America Medical Systems, Inc., Tustin, CA, which markets, sells, distributes and services radiology and cardiovascular systems, announced that Maria Piazza has been named Director, Ultrasound Business Unit.
Globus Medical, Inc., Audubon, PA, a leading musculoskeletal implant manufacturer, has appointed Daniel T. Scavilla as its Senior Vice President and Chief Financial Officer, effective May 4.
COR Medical Technologies, Houston, TX, which offers a comprehensive instant decision support system for rapid and accurate diagnosis, treatment, and follow-up management of patients with diseases involving the cardiovascular system, announced that Dr. Gregg W. Stone has been appointed to its Senior Editorial Board.
Expansions/Spinoffs/New Services/Moves
Solvay Specialty Polymers USA, LLC, Alpharetta, GA,launched an expansion at its Augusta, GA, manufacturing facility to install the first world-scale polyether-etherketone (PEEK) resin production unit in the United States and meet growing demand for Solvay’s KetaSpire® and AvaSpire® ultra-polymers.
BioSig Technologies, Los Angeles, CA, a medical device company specializing in electrophysiology, plans to hire a dozen new people as it begins fully staffing its new headquarters location in Golden Valley, MN. The LA site will remain devoted to R&D.
The Indian government recently announced plans to build its first industrial parks dedicated to medical device manufacturing. Gujarat is the planned site of the first proposed medtech park. The second is planned for Chengalpattu in Tamil Nadu. India’s National Institute of Pharmaceutical Education and Research will supervise it.
Baxter International Inc., Deerfield, IL, which manufactures products for people with hemophilia, immune disorders, infectious diseases, kidney disease, trauma, and other chronic and acute medical conditions, is expanding its medical device plant in Mountain Home, AR. The company plans to add Baxter will add 25,000 square feet to the facility.
American Durafilm Co., Inc., Holliston, MA, has moved its Tubing Division to a state-of-the-art, 9,000-square-foot production facility in Moorseville, NC. The company serves the medical device, electrical, and aerospace industries with seamless polyimide tubing and coated wire products.
Mitsui Chemicals, Inc., Tokyo, Japan, held a groundbreaking ceremony for a 2,000-ton/year plant located at its Omuta Works facility to manufacture its new advanced polyurethane elastomer, Fortimo, and the polyisocyanate, Stabio. The new plant is scheduled for commercial operation next summer.
Mergers/Acquisitions/Collaborations/Licensing
IBM, Armonk, NY, is entering new partnerships with leading companies including Apple, Cupertino, CA, Johnson & Johnson, New Brunswick, NJ, and Medtronic, Dublin, Ireland, to help optimize consumer and medical devices for data collection, analysis, and feedback. The company is also establishinga dedicated health business unit—IBM Watson Health—to be headquartered in Cambridge, MA.
Qualcomm Tricorder XPRIZE finalist teams Scanadu Inc., based at NASA Ames Research Center, and zensor, led by Jim McLaughlin, CTO of Intelesens, Belfast, Northern Ireland,have joined forces to create Team Scanadu/Intelesens, bringing together complementary expertise in their continued quest for the $10M Qualcomm Tricorder XPRIZE, a 3.5-year global competition sponsored by the Qualcomm Foundation.
St. Jude Medical, Inc., St. Paul, MN, a global medical device company, has exercised the company’s exclusive option to acquire Spinal Modulation, Inc., Menlo Park, CA, the developer of the Axium™ Neurostimulator System. After this acquisition, St. Jude Medical will become the only medical device manufacturer to offer radiofrequency ablation, spinal cord stimulation, and dorsal root ganglion stimulation therapy solutions to treat chronic pain.
Sequana Medical, Zurich, Switzerland, a medical device company focused on implantable pump systems, has entered into an agreement with Fresenius Medical Care, Homburg, Germany, the world's leading provider of dialysis products, to commercialize Sequana’s alfapump system, an automated, fully implantable pump system to manage ascites.
Sparton Corporation, Schaumburg, IL, a provider of complex and sophisticated electromechanical devices, announced that its subsidiary, Sparton Hunter Corporation, completed a merger with Hunter Technology Corporation, Milpitas, CA, an electronic contract manufacturing provider providing engineering design, new product introduction and full-rate production manufacturing solutions to test and measurement suppliers, medical device manufacturers, and a wide range of industrial customers.
Boston Scientific Corporation, Marlborough, MA, a leading global medical device company, has signed a strategic alliance with Frankenman Medical Equipment Company, Suzhou, China, a surgical equipment company serving more than 1,000 hospitals in China, to provide access to training on endoscopic technologies.
Laser manufacturer SPI Lasers, Southampton, UK, a member of the TRUMPF Group, has acquired JK Lasers, Rugby, UK, one of the world's leading manufacturers of high-power fiber lasers for industrial use.
DATEL, Mansfield, MA, a leader in the Data Acquisition and hybrid multi-chip markets providing products for military, medical, high-reliability, industrial, and scientific applications, has acquired the DATEL Business Unit from Murata Power Solutions and will operate as DATEL Incorporated, an independent employee-owned corporation. DATEL was founded in 1974 and has been owned by Intersil, G.E., C&D Technologies, and most recently by Murata Power Solutions.
InfuSystem Holdings, Inc., Madison Heights, MI, a leading national provider of infusion pumps in the US and Canada, has closed the acquisition by its subsidiary of substantially all of the assets of Ciscura Holding Company, Inc., Alpharetta, GA, a regional provider of ambulatory infusion pumps and services.
Proxy Biomedical, Galway, Ireland, a leading global innovator in the design and contract manufacturing of biomaterial implants, announced that B. Braun Surgical, S.A.Melsungen, Germany, has renewed its long-term agreement to distribute, through its existing Closure Technologies commercial teams, MotifMESH™ MacroPorous NW Implant to global territories, outside of the US, for the next five years.
Lima Corporate spa, Udine, Italy, a global medical device company providing reconstructive orthopaedic solutions, enteredinto an agreement with Zimmer Holdings Inc., Warsaw, IN, a leading manufacturer of orthopaedic products and instruments, to purchase a number of products for European markets. Under the agreement, Lima has acquired the Zimmer Unicompartmental High Flex Knee and the Biomet Discovery Elbow System within the European Economic Area and Switzerland markets. It has also acquired the Biomet Vanguard Complete Knee System for markets in Denmark and Sweden through a specific license agreement.
Noxilizer, Inc., Baltimore, MD, which provides room-temperature nitrogen dioxide sterilization technology, and Getinge-La Calhène, Vendôme, France, a leader in the isolation technologies segment, announced an exclusive global supply agreement whereby Noxilizer will provide Rapid Bio-decontamination units for Getinge-La Calhène’s isolator systems.
Miscellaneous
Mentor Graphics, Wilsonville, OR, a leader in electronic hardware and software design solutions for electronic, semiconductor, and systems companies, announced the winners of its 25th annual PCB Technology Leadership Awards in the category of Industrial Control, Instrumentation, Security, and Medical. Fujitsu Technology Solutions GmbH, Munich, Germany, which supplies a full range of infrastructure products, solutions, and services, won first place. Valtronic SA, Les Charbonnières, Switzerland, and Solon, OH, a manufacturer of miniaturized electronic products for medical device manufacturers, took second place.
Crouzet Motors, Vista, CA, has released a new specifications guide covering two series of its high-performance DCmind Brushless Motors and gearmotors, all featuring integral electronic controls for industrial, medical, mass transportation and alternative energy applications. The new guide includes speed/torque curves, connection diagrams, applications, a software overview, and information on the brand as a whole. See http://www.crouzet.com/english/products/crouzet-motors/dcmind-brushless/high-performance-dc-motors-brushless.htm#TNI21
Averna, Montreal, Canada, an industry-leading developer of test solutions and services for communications and electronics device-makers worldwide, has received Frost & Sullivan’s 2015 Global DOCSIS Cable Networks New Product Innovation Award for its pioneering DOCSIS 3.1 protocol analysis solution.
