Here is the latest batch of news from the medical products community.
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Regulatory Approvals, Standards, and Launches
Tandem Diabetes Care®, Inc., San Diego, CA, a medical device company involved in the design, development, and commercialization of products for people with diabetes who use insulin, announced that the FDA has granted the company clearance to market the t:flex™ Insulin Pump, which has the largest capacity currently available in the US.
Dune Medical Devices, Paoli, PA, announced FDA approval of an updated version of its flagship product, MarginProbe, a device that enables real-time detection of cancer at the surface of excised tissue specimens during breast-conserving cancer surgery.
NeuroMetrix, Waltham, MA, which develops wearable medical technology and point-of-care diagnostics to manage chronic pain, will launch Quell, its FDA-cleared wearable pain relief device, at the 2015 International Consumer Electronics show in January. The company expects Quell to be available over-the-counter in the second quarter of 2015.
Epic Safety, Vancouver, British Columbia, which is focusing on providing products to the senior market, has launched Epic Alert, a new line of Personal Emergency Response Systems using various sensor and communication technologies. Products will be available for purchase through distribution channels in Canada and the U.S. during the first quarter of 2015
Stereotaxis, St. Louis, MO, announced that the FDA has received FDA 510(k) clearance for its Vdrive® with V-CAS™ Catheter Advancement System in the US, representing the company’s third Vdrive system product to be cleared for market entry. Stereotaxis also announced that it has received regulatory approval of its Odyssey® product line by the Japan Pharmaceuticals and Medical Devices Agency.
Cartiva, Inc., Alpharetta, GA, a developer of innovative solutions for the treatment of cartilage damage, osteoarthritis, and other musculoskeletal conditions, has received FDA 510(k) clearance for its ProxiFuseTM Hammertoe Correction System (ProxiFuse).
Shockwave Medical, Fremont, CA, a pioneer in the treatment of advanced peripheral and coronary vascular disease, announced that it has received CE Mark regulatory approval for its Lithoplasty™ balloon catheters to treat peripheral artery disease.
PorOsteon Inc., Menlo Park, CA, a global leader in Nitinol-based porous metal technologies, has received FDA 510(k) clearance to market its new Phusion MetalTMCervical Cage, designed to to treat cervical disc disease.
HGI Industries Inc., Boynton Beach FL, a manufacturer of ultraviolet sanitizing systems, announced that it has received FDA 510(k) clearance for its Odorox MDU/Rx air purifier to be used in medical facilities.
ZEISS, Jena, Germany, has launched its new scanning electron microscope, ZEISS MultiSEM 505, which features 61 beams working in parallel, and offers a capture speed of 1,220 megapixels per second at a pixel size of 4 nm. This high acquisition speed is used for imaging neural tissue in brain research.
Helix Medical LLC, Carpinteria, CA, a supplier to the medical device, pharmaceutical, and in vitro diagnostics industries, announced that its Baldwin Park, CA, facility received FDA registration for complying under the code of federal regulations’ title 21 part 820 and gained certification under the standard for ISO 13485 quality management systems.
dBMEDx, Inc., Littleton, CO, a wireless medical device company, has received FDA 510(k) clearance to market its novel bladder scanner, the BBS Revolution™, for the non-invasive measurement of bladder volume.
EnteroMedics Inc., St. Paul, MN, has received FDA approval of its VBLOC® vagal blocking therapy, delivered by a pacemaker-like device called the Maestro® Rechargeable System, to treat obesity. The Maestro System is the first new medical device approved for obesity by the FDA in more than ten years.
SynCardia Systems, Inc., Tucson, AZ, the manufacturer of the only FDA-, Health Canada-, and CE-approved Total Artificial Heart, announced today that Tim Shannon has joined the company as its Executive Vice President, Global Commercialization.
Benvenue Medical, Inc., Santa Clara, CA, a developer of minimally invasive solutions for spine repair, announced that Rick Simmons has joined the company as Vice President of sales and Marketing.
NewAge Industries, Southampton, PA, which manufactures plastic and rubber tubing, announced the promotions of Lawrence Morano to Global Sales Manager for the company’s AdvantaPure® high purity products division and Stephen McDevitt to Assistant Inside Sales Manager.
COR Medical Technologies, Houston, TX, which offers CORcare™, a comprehensive instant outcome support system for rapid and accurate diagnosis, treatment, and follow-up management of patients with diseases involving the cardiovascular system, has apppointed Dr. Jeffrey M. Schussler to its Senior Editorial Board.
Albright Technologies, Leominster, MA, a leader in manufacturing prototype and low volume production silicone components for medical, pharmaceutical, aerospace, military, industrial and consumer applications, announced that Ryan Taylor has joined the company as the new Business Development Specialist.
Medical Murray Southeast, a regional facility of Medical Murray, Inc., North Barrington, IL, has broken ground on a new facility in Charlotte, NC. The move will double the company’s footprint and enhance Medical Murray’s capabilities as a strategic partner to medical device OEMs by expanding R&D services, as well as low volume manufacturing, packaging, and logistics.
SMC Ltd., Somerset, WI, a medical device contract manufacturer with locations in California, Wisconsin, Massachusetts, Ohio, Costa Rica, and India, announced an expansion and move to a 210,000 sq. ft. facility in Devens, MA. The expansion will consolidate three current facilities located in Sterling and Leominster, MA, into one facility, while allowing additional square footage for future growth. The new facility will have a 60,000 sq. ft. Class 8 clean room with an additional 15,000 sq. ft. Class 7 clean room.
Baxter International Inc., Deerfield, IL, which manufactures intravenous equipment, infusion pumps, and inhalation anesthetics, is expanding its medical device plant in Mountain Home, AR, to add 25,000 square feet of space and equipment at the operation.
Platinum Press Inc., Grand Prairie, TX, a leading supplier of healthcare packaging solutions for the medical device, pharmaceutical, and animal care sectors, has acquired a new 60,000 square foot packaging facility in Pine Brook, NJ.
S and Y Industries, Inc., Winfield, KS, an electronic contract manufacturer, has expanded its services and workforce, purchased a new KISS-103 Selective Soldering Machine and a new Agilent 3070 In-Circuit Test Machine, and added a second work shift.
ZOLL Medical Corporation, Chelmsford, MA, a manufacturer of medical devices and related software solutions, has reached a definitive agreement to acquire Advanced Circulatory Systems, Inc., Roseville, MN, which develops technologies to non-invasively increase circulation.
GILERO Biomedical, InField Medical, and the medical businesses of eNNOVEA and ValTech Holdings have merged to create EG GILERO, Columbus, OH, one vertically integrated resource for the medical device industry. EG GILERO offers design, tooling, testing, regulatory, manufacturing, assembly, packaging and distribution/logistics services.
Machine Solutions Inc., Flagstaff, AZ, a global supplier of process and testing solutions to the medical device industry, has acquired Steeger USA, Inman, SC, which manufactures braiding equipment for the medical devices, electronics, aerospace, and composites markets.
Lexmark International, Inc., Lexington, KY, a leading provider of printing and imaging products, software, and solutions, has acquired Claron Technology Inc., Toronto, Canada, a leading provider of medical image viewing, distribution, sharing and collaboration software technology.
Hexagon Metrology, Inc., North Kingstown, RI, which offers a comprehensive range of products and services for all industrial metrology applications, and TriMet, LLC, Fenton, MO, which provides metrology sales and services for inspection, reverse engineering, 3D scanning for 3D printing and other services and technologies, announced a strategic partnership agreement whereby TriMet is now an agent of Hexagon Metrology, offering ROMER portable arm coordinate measuring machines and serving Southern Illinois, Missouri, Kansas, Arkansas, and Oklahoma.
ExTheraMedical Corporation, Berkeley, CA, has joined a team led byBattelle, Columbus, OH,that is developing a Dialysis-Like Therapeutics (DLT) device to treat sepsis. ExThera plans to work with Battelle andNxStage Medical, Inc., Lawrence, MA, on a contract from the Defense Advanced Research Projects Agency (DARPA) to develop an innovative, new medical device.
EnteroTrack, LLC and the University of Colorado, Boulder, have executed an exclusive license agreement that will allow the company to develop and market a novel device to monitor inflammation of the gastrointestinal tract. The company was formed as a partnership betweenprofessors at the University of Colorado School of Medicine, the University of Colorado Denver, and the University of Illinois College of Medicine at Chicago.
The University of Nottingham has formed a joint venture business with Tioga, Derby, UK, an electronics specialist, to develop a technology that will allow the continual monitoring of a baby’s heart rate during resuscitation. The new business will be known as HeartLight Systems Ltd., and will work to make HeartLight a commercially viable product
Panthera MedTech, San Jose, CA, a partnership that focuses on founding new companies in mobile health, medical device, biotechnology and health information technologies, announces the acquisition of its "Project Bengal" by Avantec Vascular, Sunnyvale, CA, a company dedicated to advancing vascular therapies through innovation.
Teleflex Medical OEM, Gurnee, IL, a global leader in medical product development and manufacturing, has launched a dramatically redesigned version of its website, www.teleflexmedicaloem.com , which delivers full content and functionality across all devices such as laptops, tablets, and smartphones.
D.L.S. Electronic Systems, Inc., Wheeling, IL, presents “EMC by Your Design: An EMC Practical Applications Seminar and Workshop”, April 14 – Thurs. April 16, 2015 at the Hilton Hotel, Northbrook, IL. For more information, call 847-537-6400 or visit www.dlsemc.com/seminar .
Crouzet Motors, Vista, CA, has introduced a new 24-page specifications guide focusing on its award-winning DCmind Brush Motor Series. The full color brochure provides comprehensive information on this innovative motor series. See http://www.crouzet.com/english/products/crouzet-motors/dcmind-brush/Dcmind-Brush-DC-motors-quiet.htm .
Intelligrated, Cincinnati, OH, a leading North American-based automated material handling solutions provider, announces the launch of its redesigned OnTimeParts.com spare parts procurement website. The new site offers new, user-friendly features, a refreshed design and improved back-end integration to connect customers with an inventory of more than 75,000 original equipment manufacturer and commodity parts.
Primo Medical Group Inc., Stoughton, MA, a leader in the development and manufacture of medical devices and precision machined components, has completed its corporate name change from STD Med Inc.