Here is the latest batch of news from the medical products community. Please click the link for more.
Regulatory Approvals, Standards, and Launches
GE Healthcare, Waukesha, WI, a global medical technology company, announced that it is the first company with a low dose computed tomography lung cancer screening option approved by the FDA for lung cancer screening.
Cohera Medical, Inc., Pittsburgh, PA, which develops surgical adhesives and sealants, has received the CE Mark to market its Sylys surgical sealant for use in gastrointestinal surgical procedures.
Aurora Spine, Inc., Carlsbad, CA, has received CE Mark approval for the full line of its TiNano sterile-packed titanium coated spinal fusion implants made with PEEK thermoplastic material.
Boston Scientific Corporation, Marlborough, MA, has received FDA approval for its Innova Vascular Self-Expanding Stent System to treat narrowing or blockages in the superficial femoral artery or proximal popliteal artery.
St. Jude Medical, Inc., St. Paul, MN, a global medical device company, has received CE Mark approval for magnetic resonance imaging (MRI) conditional labeling for the its Prodigy MRI™ chronic pain system with select leads, the market’s smallest MR-conditional rechargeable implantable pulse generator.
Dexcom, Inc., San Diego, CA, a leader in continuous glucose monitoring for patients with diabetes, announced that the FDA has approved the Dexcom G5® Mobile Continuous Glucose Monitoring System. With wireless Bluetooth® technology built into the device transmitter, the G5 is the first and only fully mobile system approved by the FDA for both adults and children as young as 2 years of age that sends glucose data directly to a smartphone.
Micell Technologies, Inc., Durham, NC, a cardiovascular company adding innovative drug-delivery systems to medical devices, announced that its application for a manufacturing partner, Surgical Technologies, Inc. (STI), St. Paul, MN, a leader in medical contracting, was approved by British Standards Institution to begin full-scale manufacturing of Micell’s MiStent SES® Sirolimus Eluting Absorbable Polymer Coronary Stent System for commercial distribution in the EU and other countries where the CE Mark is accepted.
Leadership News
Mack Molding, Arlington, VT, a leading custom plastics molder and supplier of contract manufacturing services, announced that Marc Colety, a 20-year veteran of the company, has been promoted to Vice President of Procurement.
Medical Murray Inc., North Barrington, IL, a leading medical device development and contract manufacturing company, announced that Jim McKenney has joined the company as Senior Business Development Manager for the Western US region.
NuVasive, Inc., San Diego, CA, which is focused on the design, development, and marketing of products for the surgical treatment of spine disorders, has appointed Johnson Lai to the position of Chief Information Officer.
Monteris Medical, Plymouth, MN, which is developing innovative MRI-guided, laser-based brain lesion therapy, has appointed James Reinstein to its Board of Directors.
Nephros, Inc., River Edge, NJ, which develops and sells high performance liquid purification ultrafilters and a hemodiafiltration system to treat chronic renal failure, has appointed Moshe Pinto to its Board of Directors.
NeuSpera Medical, formerly known as Vivonda Medical, Santa Clara, CA, which is developing injectable neuromodulation devices, has appointed Milton Morris as President and Chief Executive Officer.
Clarity Medical Systems, Inc., Pleasanton, CA, which develops, manufactures, and markets advanced ophthalmic imaging systems and informatics tools to diagnose, manage, and treat eye disorders, announced the hiring of several new key members of its Executive Leadership Team: John P. Farugia has been hired as Vice President & Chief Marketing Officer; Eric Steuben is the new Vice President of Operations and RA/QA responsible for regulatory affairs, quality assurance, and more; Michael M. Manteiga is the new Vice President of Sales; and Wenkang Qi, PhD, joins the company as Vice President of Research & Development and Chief Technology Officer.
Bruker Corporation, Billerica, MA, a maker of high-performance scientific research instruments and high-value analytical solutions, has appointed John Ornell to its Board of Directors.
Coaxial Components Corp., Stuart, FL, which specializes in the manufacture of RF connectors, attenuators, terminations, adapters, torque wrenches, phase adjusters and cable assemblies, welcomes Donna Reilly as the newest member of the Coaxicom Sales Team.
Google Inc., Mountain View, CA, the multinational technology company soon to becomeAlphabet,announcedon its blog that the first company to become a standalone underAlphabetwill beLife Sciences, with Andy Conrad as Chief Executive Officer.
REVA Medical, Inc., San Diego, CA, focused on the development, testing, and eventual commercialization of bioresorbable stents, announced the appointment of Regina Groves as its Chief Executive Officer, effective September 21.
Direct Flow Medical, Inc., Santa Rosa, CA, an innovative structural heart company, has appointed Mary Edwards as Vice President, Regulatory and Clinical Affairs.
IPC — Association Connecting Electronics Industries, Bannockburn, IL, announced the addition of Russell Wynne, Senior Director of IT/Software, and Ayana Nickerson, Senior Director of Training and Certification Programs to its staff.
Iwaki America Inc., Holliston, MA, one of the world’s leading manufacturers of metering pumps, chemical delivery pumps, sealless, recirculation pumps and non-metallic magnetic drive centrifugal pumps and systems, announced that Ryan Diaz has been appointed to the position of Sales Engineer.
Morgan Advanced Materials plc, Windsor, UK, a global materials engineering company that designs and manufactures a wide range of high specification products with extraordinary properties, announced that Pete Raby has been appointed the company’s new Chief Executive Officer.
Expansions/Spinoffs/New Services/Moves
Qosina Corp., Edgewood, NY, which supplies disposable components to the medical industry, announced that its corporate offices and warehouse will be moving to Ronkonkoma, NY, in September. The company is relocating from 88,000 square feet to a 95,000 square foot climate controlled facility with an ISO Class 8 Clean Room.
Molex, LLC, Lisle, IL, announced that it now operates a fully ISO 146441-1:1999 Class 8-certified clean room in Thailand. The facility has less than 100,000 particulates per cubic foot of air and manufactures a variety of ISO 13485-compliant medical cables and surgical cables used in operating theatres, hospitals, laboratories, and clinics.
Catheter Research Inc., Indianapolis, IN, an emerging leader in medical device manufacturing, design, development, and product life cycle management, announced plans to move its headquarters facility to expand and relocate within Indianapolis, as well as purchase new machinery and equipment within the first half of 2016.
Orchid Orthopedic Solutions LLC, Holt, MI, a worldwide leader in the contract design and manufacture of implants, instruments, and innovative technologies for the orthopedic and medical device markets, announces that its newest facility is now open in Pune, India.
Mortara Instrument Inc., Milwaukee, WI, which designs, develops, and manufactures diagnostic cardiology and patient monitoring technologies, plans to build a 64,000-square-foot facility in Milwaukee to expand its manufacturing and distribution operations, and expects to create 150 jobs over the next five years.
NuVasive, Inc., San Diego, CA, a leading medical device company focused on minimally disruptive, procedurally-integrated solutions for spinal surgery, announced that it is actively exploring locations to build-out a new state-of-the-art medical device facility for its spinal implant and instrument manufacturing. The proposed 130,000-square-foot facility is expected to create hundreds of new jobs, and the company expects to make a decision on a site by the end of 2015.
Medline, Mundelein, IL, a global manufacturer and distributor of medical supplies, is expanding its Honea Path, SC, production facility that produces a synthetic polyisoprene material calledIsolex ™by 30 percent. It is slated to come online in March 2016.
EvonikIndustries, Essen, Germany, a specialty chemical maker, has opened its first application technology laboratory for medical devices in Shanghai, China, to provide support to device manufacturers who use Evonik polymers in their projects.
Sterigenics International LLC, Deerfield, IL, a leading global provider of contract sterilization, gamma technologies, and medical isotopes, announced a $10 million expansion at its Gurnee, IL, facility, to add a new gamma cell. The irradiator will be ready for customer product validation in October, with production to follow immediately.
Mergers/Acquisitions/Collaborations/Licensing
Medtronic plc, Dublin, Ireland,a global leader in medial technology, has signed a definitive agreement to acquire Twelve, Inc., Redwood City, CA, which is focused on the development of a transcatheter mitral valve replacement device.
Freudenberg Medical, Carpinteria, CA, a global developer and manufacturer of specialty components and minimally invasive device solutions for the medical device industry, has acquired the majority of Hemoteq AG, Würselen, Germany, a leading provider of surface coating technologies and related services for medical devices.
Sterigenics International LLC, Deerfield, IL, a leading provider of contract sterilization, gamma technologies, and medical isotopes, has acquired Sao Paulo-based Companhia Brasileira de Esterilização (CBE), the largest specialist in sterilization and microbial load reduction in Latin America.
Greatbatch, Inc., Frisco, TX, a global developer and manufacturer of medical devices and components, has agreed to acquire to acquire Lake Region Medical, Wilmington, MA, which offers fully integrated outsourced manufacturing and engineering services, contract manufacturing, finished device assembly, original device development and supply chain management services. In addition, Greatbatch has licensed wireless charging technology from WiTricity, Watertown, MA, an industry pioneer in wireless power transfer over distance, to commercialize wireless charging systems for medical devices of its own design, as well as systems and solutions for OEMs.
Theragen LLC, Leesburg, VA, a medical device company focused on developing non-invasive therapeutics to treat disease and pain, announced that it has acquired Neurotech North America, Minnetonka, MN,0 and its global assets from Bio-Medical Research LTD, Galway, Ireland. Neurotech NA is involved in developing medical device systems for muscle rehabilitation and pain management.
XIMEDICA, Providence, RI, a leading, full service, medical technologies development firm, has acquired Bridge Design, San Francisco, CA, which provides design services for physical and digital products, including mHealth.
3M, St. Paul, MN, a global innovation company, has completed its acquisition of the Separations Media business from Polypore International Inc., Charlotte, NC, a leading provider of membranes and modules for blood treatments, ultrafiltration, and gas transfer.
Miscellaneous
Vention Medical, South Plainfield, NJ, which specializes in the design, development, manufacturing, and assembly of complex medical devices and components, announced that it has launched a new website at www.ventionmedical.com .
MTD Micro Molding, Charlton, MA, a long-time leader in micro-injection molding, has released an updated “Materials Menu” of materials that can be successfully micromolded to help guide engineers at medical device companies. Download MTD’s updated materials list here: http://mtdmicromolding.com/micromolding-materials/ .
SPI: The Plastics Industry Trade Association has announced its newest event, MRO Expo, scheduled for June 8 to 9, 2016, at the Donald E. Stephens Convention Center in Rosemont, IL. Additional event information can be found at www.MROexpo.org .
This year, for the first time, COMPAMED, the leading international trade fair for suppliers of the medical technology industry will be held on the same days as MEDICA, the world's largest medical trade fair, from November 16 to 19 in Düsseldorf, Germany. The shows will run on weekdays only, from Monday to Thursday.
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,announced the launch of its new, redesigned global corporate and North America company websites, which may be found at www.GeneralCable.com .
SPI: The Plastics Industry Trade Association and IHS Chemical will jointly present the industry-leading, executive-level Global Plastics Summit from Oct. 28 to 30 in Chicago, the organizations announced. For more information, visit http://globalplasticssummit.com .
