Here is the latest batch of news from the medical products community. Please click the link for more.
Regulatory Approvals, Standards, and Launches
Medtronic, Dublin, Ireland, one of the world's largest medical technology, services, and solutions companies, has launched its VenaSeal closure system in the US, a minimally invasive procedure that uses a medical adhesive to close superficial veins of the lower extremities. The company also received FDA premarket approval for its app-based MyCareLink Smart Monitor remote monitoring system for patients with implanted pacemakers.
Boston Scientific, Marlborough, MA, a global medical technology leader, has agreed to acquire the interventional radiology portfolio of endovascular and interventional cardiology technologies provider CeloNova Biosciences, San Antonio, TX.
Ubiquity Inc., Irvine, CA, a technology development and licensing company, was awarded three patents from the U.S. Patent and Trademark Office, including one for the Medical Scan Clip-on, a device that scans medical parameters and communications via cellphone.
KATOR, Logan, UT, a medical device company focused on advanced tissue-to-bone reattachment systems, has received FDA 510(k) clearance for its suture anchor system designed for tissue-to-bone reattachment in arthroscopic rotator cuff repair surgery.
Hitachi Medical Systems America, Twinsburg, O, has received FDA clearance to market two new CT models within its Scenaria Platform, models SE 64 and SE 128 designed to facilitate higher daily scanning volumes of busy CT facilities.
VISIOMED GROUP, Paris, France, a company specializing in advanced electronic medical grade devices, announced thatitsfirstrangeofconnectedmedicaldeviceshasbeen registeredbytheFDA, opening thewayto marketing BewellConnect® products in North America.
JenaValve Technology, Inc., Irvine, CA, a developer, manufacturer, and marketer of next-generation transcatheter aortic valve replacement systems to treat aortic valve disease, has received EN ISO 13485:2012 certification for its wholly-owned manufacturing facility in Leeds, UK.
DePuy Synthes Companies, Warsaw, IN, which provides comprehensive solutions in the specialties of joint reconstruction, trauma, neurological, craniomaxillofacial, spinal surgery, and sports medicine, announces the national launch of the DEPUY SYNTHES ADVANTAGE™ Outpatient Solutions Program to facilitate best practices and protocols for joint replacement in ambulatory surgical centers and outpatient hospitals throughout the United States.
MasterControl Inc., Salt Lake City, UT, a global provider of quality management software solutions and services, announced today the milestone of being one of the first companies in the world to successfully complete a certification audit to the newly revised ISO 9001:2015standard.
Albright Technologies, Inc., Leominster, MA, a world leader insilicone prototypingandproduction molding, has achieved ISO 1385:2003 re-certification and has received an extension to its ISO registration through 2018.
St. Jude Medical, Inc., St. Paul, MN, a global medical device company and an international leader in chronic pain therapy development, announced FDA approval of its Proclaim™ Elite Spinal Cord Stimulation System, the first and only upgradeable and recharge-free spinal cord stimulation system available to people in the US suffering from chronic pain.
Moximed, Inc., Hayward, CA, dedicated to improving the standard of care for patients with osteoarthritis, has received the CE Mark for its Atlas knee system, a next-generation knee joint unloader for pre-arthroplasty patients.
Mallinckrodtplc, Chesterfield, UK, a leading specialty biopharmaceutical company, announced that the FDA has cleared its INOmax DS® Plus MRI device for delivery of nitric oxide for inhalation during MRI procedures.
Visaris Americas, Rochester, NY, a provider of digital radiography technology and PACS workflow solutionsfor the medical diagnostics market, has received FDA 510(k) clearance on its software, flat panel detectors, and various hardware offerings.
General Cable, Highland Heights, KY, a global leader in the development, design, manufacture, marketing and distribution of aluminum, copper and fiber optic wire and cable products, announces that 8 additional GenSPEED® Brand Data Communications cables have now acquired Underwriters Laboratories’ LP listing for efficient operation in high-power Power over Ethernet applications. General Cable’s GenSPEED Brand cables were the first in the industry to achieve UL’s new listing, and a total of 11 GenSPEED Brand cables have now earned the rating.
Leadership News
MELA Sciences, Inc., Horsham, PA, which is dedicated to developing and commercializing products to diagnose/treat serious dermatological disorders, announced that Christina L. Allgeier has been promoted to the position of Chief Financial Officer.
Dymax Corporation, Torrington, CT, which develops innovative oligomer, adhesive, coating, dispensing, and light-curing systems, announced the appointment of Suzanne Redding as the Market Segment Manager for the Medical Industry.
Intelligrated, Cincinnati, OH, a provider of intelligent automated material handling solutions, announces the appointment of Jon Tutuncu to the position of Senior Director, Commercial Operations and Strategy.
Wytech Industries, Inc., Rahway, NJ, a worldwide manufacturer of wire and tubing components used in devices for cardiology, neurology, peripheral intervention, vascular, orthopedic, and other markets, has named Michael Brown to the new position of Vice President of Global Business Development.
FUJIFILM Medical Systems U.S.A., Inc., Stamford, CT, a leading provider of diagnostic imaging products and medical informatics solutions, announced Johann Fernando, PhD, was named Chief Operating Officer and Diku Mandavia, MD, was named Chief Medical Officer.
Expansions/Spinoffs/New Services/Moves
TRUMPF, Farmington, CT, a world market and technology leader in fabricating machinery and industrial lasers for flexible sheet metal processing, has purchased five acres of land in Hoffman Estates, Il, to serve as the future home of the TRUMPF Technology Center and the center of excellence for Industry 4.0. It will focus on integrating automation, material, and information flow with machine tools.
Creganna Medical, Galway, Ireland, has significantly expanded its operations in Plymouth, MN, with the opening of a new 100,000 sq. ft. state-of-the-art manufacturing facility that triples Creganna Medical’s existing manufacturing footprint in Minnesota and greatly expands the company’s capacity to serve medical device customers for braid, coil, and other minimally invasive device technologies. The company expects to hire an additional 50 staff to support ongoing expansion at the site over the next 18 months.
Medical Murray, North Barrington, IL, a leading medical device development and contract manufacturing company, announces the completion of its new and expanded 6,000 square foot facility located in Charlotte, NC, which features anadditional full service laboratory space for designing, prototyping, and testing of medical devices.
Elasto Sweden, Åmål, Sweden, part of the Hexpol TPE family, announced that it has completed installation of a new production line for its medical-grade thermoplastic elastomers (TPEs). The company also has expanded the technical center at its facility in Åmål and is the first European TPE compounder to be certified to ISO 13485 for the medical device industry.
Mergers/Acquisitions/Collaborations/Licensing
Medtronic plc, Dublin, Ireland, one of the world's largest medical technology, services, and solutions companies, has acquired Aircraft Medical, Edinburgh, Scotland, which develops affordable, handheld high-quality video laryngoscopes used by anesthesiologists and critical care professionals to intubate patients.
Orchid Orthopedic Solutions, Holt, MI, a worldwide leader in design and manufacturing for the orthopedic and medical device industry, has signed an agreement to acquire the Cam Bioceramics coating facility and operations in Suzhou (Cam China), a high quality provider of hydroxylapatite plasma coatings in China.
KOA Speer Electronics, Bradford, PA, a leading supplier of passive electronic components, has added CFE-MacInnis Technology, Bohemia, NY, to represent he entire KOA Speer product line within the New York City metro area and northern New Jersey.
Measurement Computing, Norton, MA, which designs and manufactures data acquisition devices, has acquired Data Translation, Marlboro, MA, a pioneer in PC-based data acquisition, combining two companies with more than 68 years of experience in data acquisition and instrumentation.
Pasternack Enterprises, Inc., Irvine, CA a leading provider of RF, microwave, and millimeter wave products, has signed an agreement with Ducommun Incorporated, Carson, CA, a global provider of manufacturing and engineering services, to private-label manufacture select Ducommun RF products under the Pasternack brand.
Fossil Group, Inc., Richardson, TX, a global design, marketing and distribution company that specializes in consumer lifestyle and fashion accessories, announced that it has entered into a definitive agreement to acquire Misfit, Inc., Burlingame, CA, an innovator in wearable technology and stylish connected devices.
SurModics, Inc., Eden Prairie, MN, a leading provider of medical device and in vitro diagnostic technologies, has acquired Creagh Medical Ltd., Ballinasloe, Ireland, a developer and manufacturer of percutaneous transluminal angioplasty balloon catheters.
C. R. Bard, Inc., Murray Hill, NJ, a leading multinational developer, manufacturer, and marketer of medical technologies in the fields of vascular, urology, oncology, and surgical specialty products, has agreed to acquire Liberator Medical Holdings, Inc., Stuart, FL, a leading national direct-to-consumer provider of medical supplies through its subsidiary, Liberator Medical Supply, Inc.
ams, Unterpremstaetten, Austria, a leading worldwide provider of high-performance sensor and analog solutions, has entered into an agreement to acquire 100% of the shares in CMOSIS, Antwerp, Belgium, a leader in advanced area and line scan CMOS image sensors for high-end imaging applications.
Johnson & Johnson subsidiary Biosense Webster, Diamond Bar, CA, a global leader in diagnosing and treating heart rhythm disorders, has acquiredCoherex Medical, Salt Lake City, UT, which makes the Wavecrest anti-stroke device, designed to occlude the heart’s left atrial appendage to prevent blood clots from forming that could cause stroke.
ZEISS, Jena, Germany, an internationally leading technology enterprise operating in the optics and optoelectronics industries, announced that it is participating in a new public-private partnership with UC Berkeley as part of the Brain Microscopy Innovation Center (BrainMIC), a component of the Berkeley BRAIN Initiative.As part of the initiative, ZEISS has delivered a variety of high performance microscopes and imaging systems.
ALPHAEON Corporation, Irvine, CA, a social commerce company aimed at transforming self-pay healthcare through products and services to promote wellness, beauty and performance, will acquire LENSAR, Inc., Orlando, FL, a medical device company providing Femtosecond Laser technology for cataract treatment.
Integro Technologies Corp., Salisbury, NC, a leading machine vision integrator, announced its recent partnership with the NC Manufacturing Institute, which is designed to solve a growing gap between regional job seekers and available positions.
Miscellaneous
RFID in Health Care ( www.rfidjournalevents.com/healthcare ), the premier industry event, focuses on the use of radio frequency identification technology within the health-care industry. This year's event, cornerstone-sponsored by Cardinal Health, will feature a new co-located RFID for Medical Device Management seminar, sponsored by Fujitsu, Terso Solutions, and Zebra Technologies. The conference and exhibition will be held on Dec. 2-3 in San Francisco, CA.
Hexagon Metrology, North Kingstown, RI, has rebranded itself as Hexagon Manufacturing Intelligence to reflect its growing expertise and solutions for integrated industrial manufacturing.
Merit Medical Systems, Inc., Salt Lake City, UT, a worldwide designer, developer, manufacturer, and marketer of medical devices used in interventional and diagnostic procedures, and its ThinkRadial™ education program, now offers a new, one-of-a-kind vascular training model at events throughout the world. For more information about Course dates and to apply for a seat in one of the Courses, visit www.ThinkRadial.com/Courses .
TRUMPF, Farmington, CT, a world market and technology leader in fabricating machinery and industrial lasers for flexible sheet metal processing, announced that the TRUMPF Inc. training center in Farmington has been approved by the State Approving Agency of the Connecticut Office of Higher Education to train eligible Veterans Affairs (VA) educational beneficiaries.
The National Capital Consortium for Pediatric Device Innovation, Washington, DC, is now accepting proposals for medical innovations that address a significant, yet unmet pediatric need. Five prizes of $50,000 each will be awarded to the winning presentations at the consortium’s third annual competition in February 2016. The FDA-funded consortium invites innovators to propose their designs for pediatric medical devices. For competition details, visit www.innovate4kids.org/funding-opportunities .
W. L. Gore & Associates, Inc., Flagstaff, AZ, which provides creative therapeutic solutions to complex medical problems, announced in conjunction with its 40th anniversary, it has sold 40 million devices worldwide. Gore products include vascular grafts, endovascular and interventional devices, surgical meshes, staple line reinforcement materials, and sutures for use in vascular, cardiac, and general surgery.
Groschopp Inc., Sioux Center, IA,an ISO 9001:2008 motor manufacturer for OEMs and distributors, recently launched a mobile-friendly website that focuses on making the search for a motor or gearmotor simple for the user. The website, www.groschopp.com , adds a new motor search tool that enables users to easily maneuver through Groschopp products.
