Here is the latest batch of news from the medical products community. Please click the link for more.
Regulatory Approvals
X-spine Systems, Inc., Miamisburg, OH, which designs and manufactures surgical implants and instrumentation for use in spinal surgery, announced a new FDA clearance for its Silex™ sacroiliac (SI) joint fusion system. The Silex™ system allows for fusion and stabilization of the SI joint in eligible patients whom appropriate non-surgical treatment has failed.
iCAD, Inc. , Nashua, NH, a provider of advanced imaging and radiation therapy technologies to detect and treat cancer, announced that the company received FDA clearance for its new cervical applicator for use with its Xoft® Axxent® Electronic Brachytherapy System® to deliver high dose rate brachytherapy.
Ethicon Endo-Surgery, Inc., Cincinnati, OH, announced it has received 510(k) clearance from the FDA for its ENSEAL® G2 Cordless Tissue Sealer Device, which includes a generator and power source so no assembly is required.
Quantel Medical, Clermont-Ferrand, France, announced FDA 510(k) market clearance of its Vitra Multispot™ laser, developed to give access to advanced pattern-scanning technology to ophthalmology practices dealing with diabetic eye disease in their patient populations.
iTraumaCare, San Antonio, TX, an early-stage medical device firm focused on developing traumatic injury solutions for first responder and military medicine applications, has received CE Mark approval to market its first product, the iTClampTM Hemorrhage Control System, in participating European Union countries. The product, which was licensed for sale in Canada in late 2012, will be available to medical professionals in participating European Union countries within 30 to 45 days.
Advanced Bionics, Valencia CA, the global leader in cochlear implant technology and a company of the Sonova Group, has received approval by the Therapeutic Goods Administration (TGA) for Neptune™, the world’s first and only swimmable, waterproof cochlear implant sound processor in Australia.
Tenex Health, Lake Forest, CA, has received a new FDA 510(k) clearance for use for its novel TX1 Tissue Removal System, which allows the company to use the TX1 System in a broad range of applications and surgical procedures. The clearance also recognizes the technical components of the TX1 System as single use and completely disposable.
Leadership News
Orthofix International N.V., Lewisville, TX, a global medical device company focused on repair and regenerative solutions to the spine and orthopedic markets, has appointed Brad Mason as its President and Chief Executive Officer, effective immediately.
Cibiem, Inc., a medical device company leveraging its proprietary, minimally invasive, catheter-based approach to treat a broad range of sympathetic nervous system-mediated diseases, has appointed Ken Martin as president and chief executive officer. He will succeed company co-founder Howard R. Levin, MD, who will continue his active involvement within the company and as a member of its board of directors.
Becton Dickinson and Co., Franklin Lakes, NJ, has appointed Ellen Strahlman, MD, to its newly created position of chief medical officer and senior vice president of research and development. She will assume the post on April 22.
Vision-Sciences, Inc., Orangeburg, NY, a leading provider of unique flexible endoscopic products, announced that Dr. Cheryl Pegus, a cardiologist and physician executive, has been appointed to the company's board of directors
Furukawa Electric Co., Ltd. (FEC), Tokyo, Japan, has announced the appointment of two new Corporate Vice Presidents. Dr. Timothy Murray, CEO of OFS Fitel, LLC, and Foad Shaikhzadeh, President of Furukawa Industrial S.A. Produtos Eletricos (FISA) will join FEC’s global management board effective April 1st.
Bunting Magnetics Co., Newton, KS, a producer of precision magnetic products for the worldwide electronics industries, has announced personnel appointments at Bunting Magnetics Europe, Berkhamsted, England, its European subsidiary. Simon Ayling has been promoted to Managing Director of Bunting Magnetics Europe, Clive Wright has been named General Sales Manager at Bunting Magnetics Europe, and Robert Webb is now Finance Director at Bunting Magnetics Europe.
Expansions/Moves
Automation GT is moving its headquarters from Escondido to Carlsbad, the largest Life Sciences hub in Southern California. Founded in 2002, the designer and manufacturer of custom automation solutions is upgrading to a 13,000 square foot campus.
Tektronix, Inc., Beaverton, OR, a leading worldwide provider of test, measurement, and monitoring instrumentation, announced that it will enter the power analyzer instrument market and introduce a full new product line in the coming months. To facilitate this move, the company has implemented a technology transfer agreement which includes power analyzer intellectual property, patents, and product designs from its partner Voltech, which will exit the power analyzer segment of its business by September 30, 2013.
Aurora Health Care, Milwaukee, WI, has launched the Aurora Research Institute, which will centralize existing research endeavors. Aurora offers 700 clinical research projects, including over 400 clinical trials, giving patients access to more new devices than any other health care system in the state.
Hollister Inc., Libertyville, IL, a developer, manufacturer and marketer of medical devices, plans to upgrade machinery and expand its manufacturing plant in Stuarts Draft, VA. The company expand its plant an additional 50,000 square feet with warehouse space and new equipment to automate processes with robotics and high-tech equipment.
NAMSA, Northwood, OH, a global medical device research organization, has expanded its microbiology laboratory in Irvine, California. The newly expanded and state-of-the-art laboratory space will utilize the latest technology for microbiology and sterility assurance testing and will open in spring 2013. An increased demand for NAMSA’s sterility assurance and analytical services has led the company to invest in additional laboratory space in its Irvine location.
Mergers/Acquisitions/Collaborations
Cordis Corporation, Bridgewater, NJ, a worldwide leader in the development of interventional vascular technology, has completed the acquisition of Flexible Stenting Solutions, Inc., Eatontown, NJ, a developer of innovative flexible peripheral arterial, venous, and biliary stents.
Stryker Corporation, Kalamazoo, MI, has purchased spinal implant technology from VertiFlex, Inc., San Clemente, CA, an innovator of minimally invasive spinal surgery technologies.
IPG Photonics Corporation, Oxford, MA, announced the acquisition of privately held Mountain View, CA-based Mobius Photonics to accelerate its entry into the UV laser market and deepen IPG's development team. Mobius provides high-power pulsed UV fiber lasers for micromachining.
Cynosure, Inc., Westford, MA, signed a definitive agreement to acquire Palomar Medical Technologies, Inc., Burlington, MA. Both companies are aesthetic laser manufacturers.
DSM, Parsippany, NJ, a global medical materials supplier, has signed a license and supply agreement with spinal implant and surgical systems developer SpineVision, Brussels, Belgium. The agreement grants SpineVision the use of Bionate II PCU, a proprietary DSM polymer, to enhance flexibility and compression in posterior lumbar pedicle screw systems.
Brady Corp., Milwaukee, WI, a leading provider of integrated brand protection solutions has entered into a sales and marketing agreement with Verify Brand LLC, Plymouth, MN, a leader in supply chain security and management systems for manufacturers and governments. The new partnership allows Brady to resell Verify Brand’s serialization, data messaging and management, tracking, authentication, and reporting services.
KRAIBURG TPE, Duluth, GA, announces its partnership with UL IDES, an online searchable data sheet catalog of 86,000 plastic materials. Customers can now readily access KRAIBURG TPE’s product data sheets.
Interlink Electronics, Inc., Camarillo, CA, announced the integration of their FSR® 402 sensor in the PRO Occlusion Detector, a passive non-invasive, free-entry sensor designed for medical, laboratory, pharmaceutical and packaging applications, from Introtek International, Edgewood, NY.
Bioject Medical Technologies Inc., Tigard, OR, a developer and manufacturer of needle-free injection therapy systems, today announced that it has entered into three international distribution agreements, two in the Pacific Rim region and one in the Middle East. The agreements call for the sale of the Biojector®2000 gas-powered device, the Bioject® ZetaJet™ spring-powered device and accessories through qualified medical device groups located in Australia, the Republic of the Philippines, and North Africa.
Argon Medical Devices, Inc., Plano, TX, entered into a definitive agreement to acquire the Interventional Products Business of Angiotech Pharmaceuticals, Inc., Vancouver, BC, Canada. The Interventional Products Business manufactures and markets disposable and re-usable biopsy products for the diagnosis of cancer, drainage catheter products, and vascular interventional products.
Miscellaneous
ZOLL Medical Corporation, Chelmsford, MA, a manufacturer of medical devices and related software solutions, announced that it is the only company to receive the NorthFace ScoreBoard Award for “world class” excellence in customer satisfaction for the 12th consecutive year. The company was also recognized with a five-year award for excellence in customer service. Since 2000, the award has been presented annually by Omega Management Group Corp., Billerica, MA, to companies that, as rated solely by their own customers, have achieved excellence in customer satisfaction during the prior calendar year.
OMAX Corporation, Kent, WA, a global leader in the design and manufacture of advanced abrasive waterjet technology, recently announced its continued support of Aviation High School’s First® Robotics team, SkunkworksRobotics. The partnership marks the company’s sixth year of mentoring students interested in obtaining engineering and manufacturing skills.
Welch Allyn, Skaneateles, Falls, NY, a leading medical diagnostic device company, has sent a team of employees on a volunteer service trip to Haiti as part of a humanitarian effort sponsored by Heart to Heart International. For one week, the Welch Allyn group will help in the final construction of a new healthcare clinic in Place l’Or, near Léogâne, Haiti; provide daily medical assistance; and train Haitian doctors and nurses how to use the company’s diagnostic devices they have donated to local clinics in Léogâne and in Port-au-Prince, Haiti.
Sentio, LLC, Southfield, MI, which developed a proprietary nerve-mapping device that allows surgeons to find nerves they cannot see, has been recognized as one of the 2013 “Michigan 50 Companies to Watch,” an awards program sponsored by the Edward Lowe Foundation and presented by Michigan Celebrates Small Business.
