Here is the latest batch of news from the medical products community. Please click the link for more.
Regulatory Approvals, Standards, and Launches
NeuWave MedicalInc., Madison, WI, a medical device company focused on developing disruptive technology for use in the ablation of soft-tissue lesions has received FDA clearance for its new Ablation Confirmation™ software integrated into the NeuWave Intelligent Ablation System.
Teleflex Incorporated, Wayne, PA, a global provider of medical devices for critical care and surgery, announced that its ARROW Endurance™ Extended Dwell Peripheral Catheter System received market clearance from the FDA.
Stryker Orthopaedics, a division of Stryker Corporation, Kalamazoo, MI, one of the world's leading medical technology companies specializing in orthopaedics, medical and surgical, and neurotechnology and spine, has received FDA 510(k) approval for its Mako total knee application and plans a limited US market release of this application by the end of the year.
EMBA Medical™ Limited, Dublin, Ireland, which designs and develops innovative peripheral embolization technologies, announced that the company has received the CE Mark for its peripheral embolization device, the Hourglass™ Peripheral Embolization Plug.
Spine Pain Management, Inc., Houston, TX, a medical technology company that underwrites healthcare services related to liability spine injuries, announced that its Quad Video HALO, a video transparency accessory for fluoroscopy devices, has been issued a final patent by the U.S. Patent and Trademark office.
PhysIQ, Naperville, IL, a leader in developing solutions based on machine learning technology to revolutionize remote patient monitoring, has received FDA 510(k) clearance for its Personalized Physiology Analytics Engine Software.
Samsung Medison, Seoul, Korea a global medical equipment company, announced the launch of its HS70A, a new high-end ultrasound system designed for use in radiology, internal medicine, vascular, and more, for patients requiring continual diagnosis.
BIOTRONIK, Berlin, Germany, the world’s leader in ProMRI® cardiac devices, has received CE Mark approval of 3 tesla (T) MRI scanning with exclusion zone for its two latest generations of pacemakers. BIOTRONIK is now the only company offering both implantable cardioverter-defibrillators (ICDs) and pacemakers approved for 3 T scans.
Coatings2Go, Carlisle, MA, a medical device coating supplier, has received a US patent for hydrophilic coatings.
Brainreader, Horsens, Denmark, a medical device creator and service company in the field of brain volumetrics, has launched a new software product, Neuroreader, can help identify changes in brain volume associated with concussions and other traumatic brain injuries as well as a key indicator in the diagnosis of degenerative brain diseases such as Alzheimer's disease, epilepsy, and depression.
Sorin Group, Milan, Italy, a global medical device company and a leader in the treatment of cardiovascular diseases, announced the Canadian approval of its Perceval sutureless aortic valve.
AngioDynamics, Albany, NY, which produces minimally invasive medical devices for vascular access, surgery, peripheral vascular disease and oncology, has launched its BioFlo midline catheter for short-term intravenous therapies following FDA clearance earlier this year.
IEEE, the Institute of Electrical and Electronics Engineers, announced that the IEEE Standards Association has approved IEEE 11073-10417™-2015 for controlling information exchange to and from personal health devices and information management devices such as cell phones, computers, and personal healthcare appliances, such as glucose metering devices.
Uptake Medical, Tustin, CA, which is focused on treating lung cancer and emphysema, has received the CE Mark allowing the European commercial sale of its InterVapor system that uses heated water vapor to achieve bronchoscopic lung volume reduction.
Leadership News
JenaValve Technology, Inc., Irvine, CA, a developer, manufacturer, and marketer of next-generation transcatheter aortic valve repair systems, announced the appointment of Peter C. Wulff as Chief Financial Officer.
Mack Molding, Arlington, VT, a leading custom plastics molder and supplier of contract manufacturing services, has appointed Larry Hovish as Director of Communications.
EOS imaging, Paris, France, a company focused on 2D and 3D orthopedic medical imaging equipment, named Gerard Hascoet as Chairman of the Board.
St. Jude Medical, Inc., St. Paul, MN, a global medical device company, announced the appointment of David C. Dvorak, President and Chief Executive Officer of Zimmer Biomet, to its Board of Directors.
Lowell, Inc., Minneapolis, MN, a precision machining contract manufacturer specializing in the development and production of complex implantable medical devices, has appointed Udaya Joshi, MS, MBA, CSSBB, as its new Quality Assurance/CI Leader.
Stratophase Ltd., Southampton, UK, a leading provider of automated feeding systems for the bio manufacturing industry, has formed an Industry Advisory Team. Its members are: Malcolm Rhodes,an independent consultant; John Birch,a visiting professor at University College London; and Richard Archer, currentlyworking with British government on a number of national initiatives in health.
Presbia PLC, Dublin, Ireland, an ophthalmic device company, has appointed Gerd Auffarth, MD, PhD, to the Board of Directors. The board also announced the appointment of Mark S. Blumenkranz, MD, to the Presbia Medical Advisory Board.
BrainScope Company, Inc., Bethesda, MD, a neurotechnology company focused on traumatic brain injury and concussion assessment, announced the following executive appointments: Kerstin Schultz was hired as President and Chief Operating Officer, Dr. Leslie Prichep was hired as Chief Scientific Officer, Laurie Silver was promoted to Chief Financial Officer, and Angad Singh was hired as Chief Technology Officer.
V-Wave, Caesarea, Israel, an early-stage medical device company that makes innovative, implantable devices to treat patients with heart failure, announced appointments of its senior executives: Frank Litvack, MD, as Chairman and Neal Eigler, MD, as CEO.
Expansions/Spinoffs/New Services/Moves
Hexagon Metrology, North Kingstown, RI, a leader in industrial metrology applications, announced the opening of two new Hexagon Metrology Solution Centers in Milwaukee, WI, and Wilmington, DE. The offices will include a training center and a technology showroom available for customer demonstrations, seminars, and more.
Proto Labs, Inc., Maple Plain, MN, has introduced magnesium injection molding into its current rapid manufacturing services. This advanced injection molding process enables product designers and engineers to prototype using the same materials and processes used for the final part production.
Smith & Nephew, London, UK, a diversified advanced medical technology business, announced that its Advanced Wound Management unit will establish its US headquarters in Fort Worth, TX. The company’s office in St. Petersburg, FL, will move to the new facility.
Tyber Medical LLC, Morristown, NJ, which develops and markets implants for the spine and trauma markets, has moved to Hanover Township, PA, in the Lehigh Valley Industrial Park IV.
GreenPeak Technologies, Utrecht, The Netherlands, a leading low power RF-semiconductor company, announced that it has opened a new office in Mumbai, India, in response to growing demand for RF chips for operators/service providers.
Precision Medical Products Inc., Loomis, CA, a provider of DVT prevention and rehabilitation products, has leased additional space in Rocklin, CA.
Vasoptic Medical Inc., Columbia, MD, a medical-device startup focused on imaging technology to detect diabetic retinopathy, is moving its headquarters to Baltimore’s Locust Point.
Trelleborg Sealing Solutions, Jönköping, Sweden, has expanded its liquid silicone rubber (LSR) injection molding manufacturing facility in Pernik, Bulgaria, by up to 150% to allow future growth in small- to medium-sized technical LSR, especially overmolded parts.
Banner Medical, Carol Stream, IL, a processor of medical-grade metal materials, announced plans to establish a new manufacturing facility in Warsaw, IN. The company plans to create up to 76 new jobs by 2019.
Mergers/Acquisitions/Collaborations/Licensing
Nitinol Devices & Components, Inc., Fremont, CA, the largest and contract manufacturer of Nitinol-based medical devices, has successfully completed its acquisition of Interface Catheter Solutions, Laguna Niguel, CA, a pioneer in medical balloon technology. The combined company will create Confluent Medical Technologies, a leading contract manufacturer of specialized medical devices.
IBM, Armonk, NY, which is developing and commercializing cloud-delivered cognitive computing technologies, plans to acquire Merge Healthcare Inc., Chicago, IL, a leading provider of medical image handling and processing, interoperability, and clinical systems designed to advance healthcare quality and efficiency, in an effort to have IBM’s Watson unit interpret medical images to help physicians make better patient care decisions.
Google Life Sciences, now part of Alphabet Inc., Mountain View, CA, is teaming up with DexCom, Inc., San Diego, CA, which develops, manufactures, and distributes continuous glucose monitoring systems for diabetes management, to create a “bandage-sized” sensor that can monitor type 1 and type 2 diabetes, as well as upload data to the cloud to be analyzed by Google software.
Amendia, Inc., Marietta, GA, which makes spine devices, has agreed to acquire Custom Spine, Inc., Parsippany, NJ, a developer of spinal implants and instruments for the treatment of spinal disorders.
Lombard Medical, Inc., Irvine, CA, which is focused on the abdominal aortic aneurysm repair market, has agreed to purchase Altura Medical, Inc., Menlo Park, CA, which is focused on next-generation endograft technology.
Varian Medical Systems, Inc., Palo Alto, CA, a leading manufacturer of medical devices and software for treating medical conditions with radiation, has agreed to purchase Claymount, Dinxperlo, The Netherlands, a supplier of components and subsystems for X-ray imaging equipment manufacturers.
OMRON Corporation, Kyoto, Japan, a leader in industrial automation, announced that it will acquire Delta Tau Data Systems, Inc., Chatsworth, CA, a leading developer, manufacturer, and supplier of innovative, high-performance motion controllers, which will become a member of the OMRON Group. The acquisition is expected to close in early September.
Abbott, Abbott Park, IL, a global healthcare company developing diagnostics, medical devices, nutritionals, and branded generic pharmaceuticals, announced the purchase of Tendyne Holdings Inc., Stillwater, MN, a medical device company focused on developing minimally invasive mitral valve replacement therapies. In addition, Abbott secured an option to purchase Cephea Valve Technologies, Santa Cruz, CA, which is developing a catheter-based mitral valve replacement therapy.
Q Holding Company, d.b.a. Qure Medical, Twinsburg, OH, which provides integrated elastomer solutions to medical device manufacturers, has acquired Silicone Altimex, Ltd., Nottingham, England, a silicone-tubing manufacturer.
Miscellaneous
The Freudenberg Group, a global technology group, Carpinteria, CA, has rebranded Helix Medical and MedVenture Technology under the umbrella name of Freudenberg Medical, LLC. Freudenberg Medical develops and manufactures specialty components and minimally invasive device solutions for medical device OEMs worldwide.
Orchid Design, a division of Orchid Orthopedic Solutions, Shelton, CT, has been selected by the FDA to be the sole regulatory consulting firm to participate in their submission tracking initiative. The FDA is piloting a web-based program to track the status and key details of 510(k) submissions in an effort to add transparency and eliminate confusion surrounding the often misunderstood “FDA Review Clock.”
Littelfuse, Inc., Chicago, IL, a global leader in circuit protection, has been honored by Huawei Technologies Co., Ltd., Shenzhen, China, a leading global information and communications technology (ICT) solutions provider, with a Best Delivery Supplier Award for its service to Huawei during the second half of 2014. Littelfuse was also recognized by Future Electronics with the 2014 Best Growth Supplier Award for suppliers located in South-East Asia.
Hexagon Metrology, North Kingstown, RI, which offers a range of products and services for all industrial metrology applications, announced that registration is now open at hxgnlive.com for the Metrology/Manufacturing track at the forthcoming HxGN LIVE event being held at the Asia World Expo, November 18 to 20, 2015, in Hong Kong. HxGN LIVE is Hexagon’s international user conference, a forum for customers to access information about the latest trends in geospatial and industrial enterprise technologies.
The 15th annual coolingZONE Thermal Management Summit for electronics thermal engineers take place October 20-22, 2015 in a globally-accessible, online summit covering thermal management, heat transfer, and energy transport at all hardware levels. More information can be found here http://www.coolingzone.com/event.php?eventid=60 , including online registration tools.
