Here is the latest batch of news from the medical products community. Please click the link for more.
Regulatory Approvals, Standards, and Launches
Biotronik International, Berlin, Germany, a multinational biomedical technology company, has received FDA approval for its BioMonitor 2 insertable cardiac remote monitor with ProMRI technology.
FUJIFILM SonoSite Inc., Bothell, WA, which is developing ultrasound solutions for point-of-care visualization access, has received the CE Mark and FDA 510(k) clearance for its new mountable ultrasound system, the SonoSite SII, developed for regional anesthesia, vascular access, and trauma applications.
Nevro Corp., Redwood City, CA, a global medical device company focused on evidence-based solutions to treat chronic pain, has received FDA approval for its surgical leads, which are specifically designed for use with the Senza® Spinal Cord Stimulation System.
St. Jude Medical, Inc., St. Paul, MN, a global medical device company, recently received FDA approval of the company’s proprietary, first-to-market MultiPoint™ Pacing technology and announced the US launch and first US implants of the Quadra Assura MP™ cardiac resynchronization therapy defibrillator.
Dymax Corporation, Torrington, CT, which develops innovative oligomer, adhesive, coating, dispensing, and light-curing systems, has announced that its T ridak® Model 3200 Piston Inserter , has received the CE Mark, making this automatic air-bleed system available in Europe and other regions.
MedAccred, Warrendale, PA, an industry-managed critical process supply chain oversight program, announced that Solar Atmospheres, Inc., Souderton, PA, which provides vacuum heat treating and brazing servces to the medical, defense, aerospace, and automotive markets, has become the first company to receive MedAccred critical process reaccreditation. In addition, Solar Atmospheres expanded its scope of accreditation to include Hardness Testing and Metallography & Microindentation Hardness.
Ortho Kinematics‚ Inc., Austin, TX, a diagnostics company focused on spine imaging informatics, has received the CE Mark for its lead product, Vertebral Motion Analysis, a diagnostic test for the assessment of spinal motion and radiographic instability.
AtriCure , Inc . , Mason, OH, a leading innovator in treatments for atrial fibrillation and left atrial appendage management, has received FDA 510(k) clearance for its AtriClip PRO2 Left Atrial Appendage Exclusion System.
MEDICREA, Lyon, France, which offers patient-specific implant solutions to treat spinal conditions, has received FDA approval of its first patient-specific UNiD™Cervical rod for spine surgery, secured by their complementary PASS OCT® posterior cervical stabilization system.
Royal Philips, Amsterdam, The Netherlands, has achieved FDA 510(k) clearance for low-dose lung cancer screening using its suite of 27 computed tomography (CT) and PET/CT models, as well as integrated software and services models.
Boston Scientific, Marlborough, MA, a global medical technology leader, has received FDA approval for products deemed safe for use in a magnetic resonance imaging (MRI) environment: the ImageReady MR-Conditional Pacing System, and its new INGEVITY MRI pacing leads, designed to treat bradycardia.
Leadership News
Advanced Mechanical Technology Inc. (AMTI), Watertown, MA, which designs and manufactures the industry standards in force measurement devices, orthopedic implant testing machines, and other specialty instruments, has announced that Mary Beth Schmidt, PhD,has joined the company as Chief Technology Officer. Previously, as a contractor for the AMTI wear testing laboratory, she performed wear tests for emerging medical device companies and provided hands-on training for simulator customers.
Expanding Orthopedics Inc., Atlanta, GA, which is developing and marketing innovative products designed to address unmet clinical needs for spine care, has named Dale Binke as Vice President of US sales.
TruTag Technologies, Inc., Emeryville, CA, a leader in product authentication and brand security solutions, announced that Barry McDonogh has joined the company as Vice President of Business Development.
Flextronics International Ltd., Singapore, a leading sketch-to-scale™ solutions company that designs and builds intelligent products for a connected world, announced that John Carlson has been appointed president of Flex Medical Solutions, San Jose, CA.
Freedom Innovations, Irvine, CA, which designs, manufactures, and markets advanced technology lower extremity prosthetic devices, announced that its Board of Directors has appointed David A. Smith as Chairman and Chief Executive Officer. Maynard Carkhuff will assume the role of Vice Chairman and Chief Innovation Officer as well as chair the Board’s Technology and Product Portfolio Committee.
Expansions/Spinoffs/New Services/Moves
RAUMEDIC Inc., Helmbrechts, Germany, a worldwide development partner and system supplier for medical tubing, injection molded parts, and catheters, has opened its first US development center and state-of-the-art production facility this month in Mills River, NC.
Boston Scientific, Marlborough, MA, a global medical technology leader, announced that its new medical device manufacturing plant in Batu Kawan Industrial Park in Penang, Malaysia, is set to open in the 4th quarter of 2017.
Materialise NV, Leuven, Belgium, a provider of 3D printing software and services in a variety of industries, held an official opening ceremony for the metal printing production line at its Metal Competence Center in Bremen, Germany.
Wacker Chemie AG, Munich, Germany, opened a new polysilicon production site in Charleston, TN. Wacker expects the plant to reach full capacity of more than 20,000 metric tons per year in the third quarter of 2016. Currently, the site has about 600 employees and, when fully operational, should have 650.
Zimmer Biomet, Warsaw, IN, a global leader in musculoskeletal healthcare, has entered an agreement to acquire Cayenne Medical, Scottsdale, AZ, which designs, develops, and markets technically advanced soft tissue reconstruction solutions for the knee, shoulder, and extremities.
B. Braun Medical Inc., Irvine, CA, which develops, manufactures, and markets innovative medical products and services to the healthcare industry, announced plans to invest $100.5 million to take over and add 54,000 square feet of space to the Gambro manufacturing plant in Daytona Beach, FL. The facility, currently operated by Baxter International, will become B. Braun's second US intravenous solutions plant and is expected to generate about 175 new jobs by 2019.
Milacron Holdings Corp., Cincinnati, OH, a leading industrial technology company serving the plastics processing industry, has completed another round of expansions to its injection, blow, and extrusion molding machine manufacturing facility in Ahmedabad, India, as well as its hot runner manufacturing facility in Coimbatore. The Ahmedabad facility added an additional 9,304 square meters to be used for machining and assembly, bringing the total footprint to 65,000 square meters. In Coimbatore, Milacron’s hot runner brand, Mold-Masters, recently added a large brazed furnace, allowing the India operations to manufacture Mold-Masters proprietary iFLOW manifold technology.
AsteelFlash, Paris, France, an international electronic manufacturing servicescompany, has begun production at its newly built state-of-the-art facility in La Soukra, Tunisia. The 113,020 square foot facility will officially open later this year. The company operates 18 manufacturing sites on 4 continents.
Mergers/Acquisitions/Collaborations/Licensing
Abbott, Abbott Park, IL, a global healthcare company with a portfolio of offerings in diagnostics, medical devices, nutritionals, and branded generic pharmaceuticals,announced that it was acquiring St. Jude Medical, Inc., St. Paul, MN, a global medical device company, in order to expand its cardiac and neurological businesses and create a global medical devices company with specialties such as cardiovascular, diabetes, and vision. St. Jude currently has about 18,000 employees worldwide, while Abbott has about 74,000 employees.
Brainlab AG, Munich, Germany, a leader in cranial SRS software development, and Dalhousie University, Nova Scotia, Canada, a leading research-intensive university, have entered into an exclusive intellectual property license agreement for integration with next generation radiosurgery software.
Halyard Health, Alpharetta, GA, a developer of infection prevention solutions, has entered an agreement to acquire CORPAK MedSystems, Buffalo Grove, IL, which specializes in enteral access devices.
InfuSystem Holdings, Inc., Madison Heights, MI, a leading national provider of infusion pumps and related services for the healthcare industry in the US and Canada, announced that its subsidiary, InfuSystem Inc., has reached an agreement to acquire the infusion pump assets of InfusAID, LLC, West Chester, PA, a regional provider of ambulatory infusion pumps and services to medical facilities.
Advanced Catheter Therapies (ACT), Chattanooga, TN, has signed a worldwide license deal with Toray Industries, Tokyo, Japan, a global integrated chemical industry group, to manufacture, market, and sell the patented and FDA-cleared Occlusion Perfusion Catheter®, a targeted therapeutic agent delivery system for the exclusive field of peripheral vascular stenosis and restenosis.
NAMSA, Northwood, OH, a microbiology and sterility assurance lab supporting US and European medical device and pharmaceutical manufacturers in the region, is pleased to announce the addition of Microbiological Compliance Laboratories as NAMSA’s local agent in Costa Rica.
Maxwell Technologies, Inc., San Diego, CA, a leading developer and manufacturer of ultracapacitor-based energy storage and power delivery solutions, has entered into a definitive agreement to sell its microelectronics product line to Data Device Corporation, Bohemia, NY, a subsidiary of ILC Industries, Inc., and a leader in the design and manufacture of high-reliability data bus, motion control, and solid-state power controller products.
Bemis Company, Inc., Neenah, Wi, a major supplier of flexible and rigid packaging, has signed a definitive agreement to acquire the medical device packaging operations and related value-added services of SteriPack Group, Offaly, Ireland, a global manufacturer of sterile packaging solutions for medical device and pharmaceutical applications. This acquisition includes a facility in Ireland as well as packaging production assets in Malaysia and the US. SteriPack Group will continue to independently own and operate its contract manufacturing services business.
Auris Surgical Robotics, Inc., San Carlos, CA, a developer of robotic microsurgical devices for ophthalmic procedures, has signed a definitive merger agreement under which Auris will acquire Hansen Medical, Inc., Mountain View, CA, a leader in the field of intravascular robotics.
Proven Process Medical Devices Inc., Mansfield, MA, a global leader in the design, development, validation, and manufactureof Class II and Class III medical devices,has been selected to manufacture StepWatchTM, a Class II, scientifically validated, highly-accurate wearable device for Modus Health LLC, Boston, MA, a health technology company delivering clinical mobility solutions.
Nokia, Espoo, Finland, a global leader in the technologies that connect people and things, has announced plans to acquire Withings S.A., Paris, France, a pioneer and leader in digital health devices. Withings will be part of the Nokia Technologies business.
Integrated Device Technology, Inc. (IDT), San Jose, CA, which designs and develops system-level solutions, announced that Huawei Technologies Co. Ltd., Shenzhen, China, a multinational networking and telecommunications equipment and services company, has selected IDT’s RapidIO technology for its new video platform because of its blend of ultra-low latency and scalability, which enable top-shelf high-definition video solutions.
The Jacobs Institute at the University at Buffalo Center for Translational Research announced a partnership with Stratasys Ltd., Eden Prairie, MN, a major manufacturer of 3D printers and 3D production systems, to advance the use of the emerging technology in medicine. Stratasys will consider the Jacobs Institute a 3D Printing Center of Excellence, and use the partnership to glean medical and engineering feedback about the printer and materials, while showcasing current and potential 3D printing applications, officials said.
Miscellaneous
Fresenius Medical Care North America, Waltham, MA, which specializes in kidney care, hospitalist services, and renal products, announced that its dialysis division has changed its name to Fresenius Kidney Care, to better demonstrate its focus.
Davis‐Standard, LLC, Pawcatuck, CT, a global leader in the design, development, and distribution of extrusion and converting technology, announced that DS Brookes Ltd., its subsidiary in West Midlands, UK, will now be called Davis-Standard Limited. Davis-Standard Limited will continue supplying screws and barrels associated with the DS Brookes brand, and will remain the company’s key supplier of extrusion systems for the Europe, Middle East, Africa region, including support of aftermarket and spare parts activities across all product platforms and heritage brands under the Davis-Standard umbrella.
Champion Medical Technologies, Lake Zurich, IL, a provider of systems that help hospitals better manage implantable devices and tissue, has renamed itself Champion Healthcare Technologies to more accurately reflect its corporate mission.
SL Power Electronics, Ventura, CA, an industry leader in power solutions designed to comply with electromagnetic interference, electromagnetic compatibility, and thermal performance, announces upcoming regional sales conferences are scheduled for San Jose, CA, on May 25, as well as ones for Germany and China. For more information, visit www.slpowerconference.com .
Tech-Etch, Plymouth, MA, which manufactures a complete line of standard and custom shielding products, has released a new catalog in both interactive PDF and printed versions detailing all standard and custom EMI/RFI shielding product options. Visit http://www.tech-etch.com/shield to download the PDF version or to request a printed catalog.
