Here is the latest batch of news from the medical products community. Please click the link for more.
Regulatory Approvals and Launches
Baxter International Inc., Deerfield, IL, announced completion of CE marking in Europe for the VIVIA hemodialysis system, designed to deliver more frequent, extended duration, short daily or nocturnal home hemodialysis therapy.
W.L. Gore & Associates, Inc., Flagstaff, AZ, announced that the FDA recently approved the GORE® VIABAHN® Endoprosthesis and GORE® VIABAHN® Endoprosthesis with Heparin BioActive Surface stent used to treat narrowing or blockage in a blood vessel or a blood clot that has developed where a vein and an arteriovenous access graft connect.
Smiths Medical, St. Paul, MN, a leading global medical device manufacturer, announced today it has received FDA 510(k) clearance to market its CADD®-Solis pain management system version 3.0 with Programmed Intermittent Bolus and Patient Controlled Analgesics delivery.
Reverse Medical, Irvine, CA, announced that it has received 510(k) clearance from the FDA for its MVP-5 micro vascular plug system.
Express Manufacturing, Inc., Santa Ana, CA, a leader in electronics manufacturing services, announces that its direct subsidiary, EMI Asia Limited, was awarded EN/JISQ/AS9100:2009 in 2012 and successfully passed the annual audit conducted by DNV in December.
Delphinus Medical Technologies, Inc., Plymouth Township, MI, innovator and developer of a new ultrasound platform that images the entire breast, has received FDA 510(k) clearance for the SoftVue™ whole breast ultrasound tomography system, approved for diagnostic breast imaging.
K2M, Inc., Leesburg, VA, the largest privately held spinal device company in the world, has received FDA 510(k) clearance to market its CAYMAN® Minimally Invasive, part of a family of plate systems to address fractures, tumors, and degenerative conditions in the spinal column.
Cardica , Redwood City, CA, has received FDA 510(k) clearance for the MicroCutter XCHANGE 30 device used in minimally invasive laparoscopic gastrointestinal procedures and appendectomies.
EarlySense, Waltham, MA, has received FDA 510(k) clearance for EarlySense 2.0 System, a newly designed bedside monitor for continuous measurement of respiration rate, heart rate, and motion.
Direct Flow Medical, Inc
Ocular Therapeutix, Bedford, MA, announced that the FDA has approved its ReSure Sealant, the first gel sealant for use in stopping fluid from leaking through the incision in a patient’s cornea after cataract surgery.
BioCardia, Inc., San Carlos, CA, has received the CE Mark for its Helix 953L Catheter as part of itsHelix Transendocardial Delivery Systemfor infusion of biologics to the heart. The new catheter is optimized for larger, dilated hearts.
Excelsior Medical Corporation, Neptune, NJ, has received FDA 510(k) clearance for its SwabCap luer access valve disinfection cap line of products.
Joining Technologies, Inc., East Granby, CT, a premier supplier of laser manufacturing services and systems, has announced the promotion of company President Dave Hudson to the position of Chief Executive Officer. The company’s founder and former CEO, Michael Francoeur, will act as Chairman.
Cutera, Inc., Brisbane, CA, a leading provider of laser and other energy-based aesthetic systems, announced the addition of Scott Ashworth as Executive Vice President of Global Sales.
The ExOne Company, North Huntingdon, PA, a global provider of 3D printing machines and printed products to industrial customers, announced that Rainer Hoechsmann has been appointed as Chief Development Officer. This newly established global position is in addition to his existing responsibility as General Manager of ExOne GmbH.
Bunting Magnetics Co., Newton, KS, a producer of precision magnetic products various industries, has hired Gregory L. Massey as Territory Manager for Standard Products, responsible for sales in Alabama, Mississippi, Louisiana, Arkansas, and Tennessee; and Alex J. Schlosser as Territory Manager for Standard Products, with responsibility for sales in Southern California, Arizona, New Mexico, and Clark County, NV.
Intelligrated®, Cincinnati, OH, a leading automated material handling solutions provider, announces the hire of Chris Lingamfelter as Vice President, Integrated System Sales and Strategy.
ZetrOZ, Inc., Trumbull, CT, a medical device manufacturer specializing in wearable ultrasound technology, has appointed its first advisory board members: Kevin Wilk, PT, DPT, Associate Clinical Director for Champion Sports Medicine and Director of Rehabilitative Research at the American Sports Medicine Institute, and Thomas M. Best, MD, PhD, a professor and Pomerene Chair, Division of Sports Medicine, Department of Family Medicine at Ohio State University Wexner Medical Center.
Mack Molding, Arlington, VT, reports with sorrow the death of the company’s Director, Business Development, Larry Walck, due to a tragic sledding accident last weekend. He had joined the company in 2000.
DMG MORI USA, Hoffman Estates, IL, a leading global provider of machine tools, turning centers and lathes, will be opening local facilities in Tampa, FL; Parsippany, NJ; Wichita, KS; Kansas City, OK; and Tulsa, OK.
Nordson Corporation, Carlsbad, CA, announced that its Advanced Technology Systems operation in Taiwan, which manufactures precision dispensing, fluid management, test and inspection, and surface treatment products, has moved to a new facility that doubles its footprint and will encompass enhanced engineering, applications, sales, service, and support for its electronics manufacturing customers.
PCC (Plastics Color Corporation), Calumet City, IL, a leading supplier of color concentrates, compounds, custom-functional masterbatches, and other polymer technologies, has announced plans to significantly expand production capacity at its Calumet City, Illinois manufacturing facility. The expansion will add 40,000 square feet to the building and a minimum of one multi-function production line.
Aries Electronics, Bristol, PA, a manufacturer of standard, programmed, and custom interconnection products and test sockets used worldwide, signed Promise Technologies as its representative responsible for promoting the company’s product line in the states of Minnesota, North and South Dakota, and western Wisconsin.
AtriCure, Inc., West Chester, OH, a leading atrial fibrillation medical device provider, has agreed to acquire Endoscopic Technologies, Inc. (Estech), San Ramon, CA, which develops and markets a portfolio of innovative surgical ablation devices using temperature controlled RF energy.
AMETEK, Inc., Berwyn, PA, a leading global manufacturer of electronic instruments and electro-mechanical devices, has acquired Teseq Group, Luterbach, Switzerland, a leading manufacturer of test and measurement instrumentation for electromagnetic compatibility testing.
MC Machinery Systems, Inc., Wood Dale, IL,wholly owned by Mitsubishi Corp., announces its partnership with Matsuura Machinery Corporation, Fukui City, Japan, in introducing the new LUMEX Avance-25 metal laser sintering hybrid milling machine to the North American marketplace.
Stryker Corporation, Kalamazoo, MI, and NeuroLogica, Danvers, MA, a subsidiary of Samsung Electronics America Inc., announced an exclusive partnership agreement in which Stryker will promote and sell NeuroLogica's BodyTom portable full body CT scanner for the specialties of neurosurgery, spine surgery, orthopaedic surgery, and trauma surgery in conjunction with the Stryker NAV3iSurgical Navigation Platform.
Watson-Marlow Pumps Group, Wilmington, MA, a world-leading positive displacement pump manufacturer, has acquired Bio Pure Technology Limited, Portsmouth UK, which specializes in the design and production of advanced single-use tubing connector systems for biopharmaceutical customers.
SunTech Medical, Morrisville, NC, a supplier of non-invasive blood pressure monitoring technology, has signed a cooperation contract with leading medical engineering company Corscience GmbH & Co. KG, Erlangen, Germany. The two companies will work together incorporating SunTech’s blood pressure measurement technology into new cardiovascular diagnostic products.
Globus Medical, Inc. implant manufacturer, has acquired Excelsius Surgical, Phoenix, AZ, which is developing a surgical robotic positioning platform for spine, brain, and therapeutic markets.
Medtronic , Inc ., Minneapolis, MN, has bought TYRX, Inc., Monmouth Junction, NJ, a developer of implantable combination antibiotic drug and implanted medical devices.
Carl Zeiss Meditec Inc., Ontario, CA, a subsidiary of Carl Zeiss Meditec AG, Jena, Germany, has purchased Aaren Scientific Inc., Ontario, CA, a manufacturer of intraocular lenses, most commonly used in cataract surgery.
Medical Murray, North Barrington, IL, a leading designer, developer, and contract manufacturer of unique complex catheter systems, permanent implants, and bioabsorbables, announced the unveiling of its newly re-designed website at http://www.medicalmurray.com .
Avalon, Rancho Dominguez, CA, a leading provider of development and manufacturing services for polymer solution casting, announced the launch of its new web site, http://avalonlabs.com , showcasing its product and technology capabilities.
Davis-Standard, Pawcatuck, CT, a global leader in the design, development, and distribution of extrusion and converting technology, announced the launch of its new website, http://www.davis-standard.com .
NuSil Technology LLC, Carpinteria, CA, recently received the Supplier Recognition Award from medical device manufacturer Mentor. With this inaugural award, the stand-alone business unit of surgical care product organization Ethicon, under Johnson & Johnson (J&J), formally acknowledges outstanding suppliers who consistently provide high-quality materials and first-rate customer support.
Phillips-Medisize Corporation, Hudson, WI, has received the prestigious Green Master distinction from the Wisconsin Sustainable Business Council for the third consecutive year. The Green Master distinction signifies Phillips-Medisize as a business leader in sustainability, by scoring in the top 20% of companies that participated.
Nonin Medical, Inc., Minneapolis, MN, inventor of finger pulse oximetry and a leader in noninvasive medical monitoring, announced that its Nonin 3230 Bluetooth® Smart finger pulse oximeter was selected as one of 12 finalists for the 2014 Bluetooth Breakthrough Awards Program, sponsored by the Bluetooth Special Interest Group (SIG). More than 200 entries were received by Bluetooth SIG, who will announce the winners in February at the Mobile World Congress in Barcelona.
ULVAC Technologies, Inc., Methuen, MA, a leading supplier of production systems, instrumentation, and vacuum pumps for technology industries has delivered the first domestically manufactured NE-550EXa plasma etching system to a government research facility, in the Washington, DC area. The NE-550EXa is typically used in applications for III-V materials, insulating layers, organics, metals, ceramics, and MEMS devices.
UNITED GRINDING, Miamisburg, OH, will conduct live grinding demonstrations on its new compact, grinding machine STUDER S11 at on a six-city tour in the US and at two events in Canada and Mexico. The US locations are in Greer, SC (Feb. 19 and 20); Rochester, NY (Feb. 26 and 27); Brecksville, OH (March 5 and 6); Livonia, MI (March 12 and 13); Itasca, IL (March 26 and 27) and Los Alamitos, CA (April 22 and 23). The open house in Canada will take place April 8 and 9 in Woodbridge, Ontario, while the dates and location for the open house in Mexico will be forthcoming.