Here is the latest batch of news from the medical products community. Please click the link for more.
Regulatory Approval
AngioDynamics, Albany, NY, a provider of minimally invasive medical devices for vascular access, surgery, peripheral vascular disease and oncology, announced it has received two key port product clearances. The FDA granted 510(k) clearance for the Xcela Plus Port family to Navilyst Medical, an AngioDynamics company. And, the company has received the Medical Device License from Health Canada to market and sell the Smart Port CT family of power-injectable ports.
Royal Philips, Andover, MA, has received FDA clearance for its AlluraClarity live image guidance system for radiological interventions. It employs Philips’ proprietary ClarityIQ technology, which consists of a multitude of software and hardware improvements that combine high quality imaging with low X-ray dose.
CorMedix Inc., Bridgewater, NJ, received CE Mark approval for Neutrolin®, a catheter lock solution, for patients with central venous catheters on hemodialysis secondary to advanced chronic kidney disease.
Retina Implant AG, Reutlingen, Germany, has won CE mark approval for its Alpha IMS wireless subretinal implant technology. The Alpha IMS is designed to restore partial vision in patients suffering from retinitis pigmentosa.
TYRX, Inc., Monmouth Junction, NJ, announced that it has received FDA clearance to market its Fully Resorbable AIGISRx R Antibacterial Envelope for use with pacemakers and implantable cardioverter defibrillators.
The Director of the United States Patent and Trademark Office has issued Rhythmlink International, LLC, Columbia, SC, exclusive rights to its innovative design for a new electrode deployment piece, refererred to as the slider™ electrode.
DJO Global, Inc., Vista, CA, has received FDA 510(k) clearance and announces the launch of the Empi PhoenixTM, an electrical stimulator designed to help simplify treatment of muscle atrophy before and after surgery for total knee replacement or ACL repair.
ForeverGreen Worldwide Corporation, Orem, UT, which develops, manufactures, and distributes all natural products, announced that the company had received FDA listing as a Class 1 Medical device for its PowerStrips as a pain relief product.
Leadership News
RF Surgical Systems Inc., Bellevue, WA, a market leader in the detection and prevention of retained surgical items, announced the appointment of John T. Buhler as President and Chief Executive Officer.
Nordson Corporation, Westlake, OH, announced that its President & CEO, Michael F. Hilton, has received the Ernst & Young Entrepreneur Of The Year 2013 award in the Public Company Category for the Northeast Ohio Region.
DJO Global, Inc., San Diego, CA, a global provider of medical device solutions for musculoskeletal health, vascular health, and pain management, announced the appointment of Sharon Wolfington, as its new President of Global Recovery Sciences business unit.
Expansions/Moves
Natvar, a division of Tekni-Plex, Inc., King of Prussia, PA, and a global supplier of tubing for medical device manufacturers, will open its first Latin American production plant in Cartago, Costa Rica, in August.
PHOTONIS Technologies, Merignac, France, a world leader in night vision sensor innovations, announced that the company has created a new business unit that will exclusively concentrate on the research, design, development, and manufacture of digital low-light imaging technologies. The new division, to be known as PHOTONIS Digital Imaging, will be headquartered in Frisco, TX.
Olympus, Center Valley, PA, a precision technology leader in designing and delivering innovative medical and surgical solutions, among other core businesses, will unveil its new Medical Learning Center in the Lehigh Valley. The Medical Learning Center, a 2,875 square foot modern training facility featuring cutting-edge medical technology, will be used to train Olympus employees and distributor partners from across North and South America.
The Bothell Biomedical Manufacturing Innovation Zone, Bothell, WA, announced the opening of Mercury Medical Technologies, a medical device incubator at Lake Washington Institute of Technology. Mercury MedTech can house up to four companies in residence, but will also operate as a virtual incubator. Companies not physically located at Mercury MedTech may engage and take advantage of advisors, vendors, and the prototyping capabilities of the in-house machine shop.
Mergers/Acquisitions/Collaborations
Stinger Medical, Murfreesboro, TN, a manufacturer and provider of mobile clinical workstations and medical technologies, has merged with Enovate, Canton, MI, a manufacturer and provider of mobile and wall-mounted point-of-care work station solutions.
Liberty Test Equipment, Roseville, CA, a leader in the test equipment industry, will be the exclusive world-wide distributor of power meters and sensors from Giga-tronics, Inc., San Ramon, CA, while continuing to provide rental services for all Giga-tronics RF and Microwave Test and Measurement products.
Boston Scientific Corporation, Natick, MA, has entered into a definitive agreement to acquire Bard EP, Lowell, MA, the electrophysiology division of C.R. Bard, Murray Hill, NJ.
Jabil Circuit, Inc., St. Petersburg, FL, has completed its acquisition of Nypro, Inc., Clinton, MA, a provider of manufactured precision plastic products for customers in the healthcare, packaging, and consumer electronics industries.
ZOLL Medical Corporation, Chelmsford, MA, a manufacturer of medical devices and related software solutions, has purchased the assets of CoAxia, Inc., Maple Grove, MN, an early revenue stage medical device company that provides catheter-based perfusion augmentation therapies.
Vention Medical, Salem, NH, a medical device solutions partner in design, engineering, component manufacturing, and finished device assembly, announced its acquisition of RiverTech Medical, Chattanooga, TN, a leading supplier of polyimide tubing, braided polyimide, composite tubing and wire coatings for numerous medical devices and medical device applications.
LeMaitre Vascular, Inc., Burlington, MA, a provider of peripheral vascular devices and implants, has acquired the assets of Clinical Instruments International, Inc., Southbridge, MA, , which manufactures carotid shunts and embolectomy catheters.
Smith & Nephew plc, London, UK, a global medical technology business, has agreed to acquire certain assets related to the distribution of its orthopaedic reconstruction, trauma, and sports medicine products in Turkey, currently conducted through Plato Grup.
Milestone Scientific Inc., Livingston, NJ, a leading medical R&D company that designs and patents innovative injection technology, has entered into a strategic partnership with Tri-anim Health Services, Inc., Valencia, CA, the nation’s largest provider of specialty sales and distribution solutions for healthcare, a unit of Sarnova Inc. During the three-year term of the strategic partnership, Tri-anim will hold the exclusive rights to market, resell, label, and distribute Milestone’s injection technology.
Miscellaneous
APMI International, professional society for the powder metallurgy (PM) industry, has named Olle Grinder, Consultant, PM Technology AB, and Roger Lawcock, Director, Product & Process Development, Stackpole International, to the 2013 Class of Fellows.
