Here is the latest batch of news from the medical products community. Please click the link for more.
Regulatory Approvals, Standards, and Launches
Mauna Kea Technologies, Suwanee, GA, a global medical device company focused on providing direct visualization at the cellular level, has received FDA 510(k) clearance for use of its Cellvizio, a multidisciplinary confocal laser endomicroscopy platform, in surgery.
ALung Technologies, Pittsburgh, PA, a developer of advanced medical devices for treating respiratory failure, has been granted an Expedited Access Pathway designation from the FDA for its Hemolung Respiratory Assist System, which provides respiratory dialysis by removing carbon dioxide directly from the blood.
Masimo, Irvine, CA, aglobal leader in noninvasive monitoring technologies, is releasing its MightySat pulse oximeter in the US following FDA clearance of the device, which is designed for personal use and provides accurate readings even when the user’s hands are shaky and when blood perfusion through the fingers is reduced.
Deerfield Imaging, Minneapolis, MN, a leader in image guided therapy solutions, announced that the FDA has approved its SYMBIS Surgical System for use in stereotactic brain biopsies. The system merges intraoperative imaging with robotic technology.
Leadership News
Baxter International, Deerfield, IL, which focuses on products to treat hemophilia, kidney disease, immune disorders, and other chronic and acute medical conditions, announced it has named José (Joe) Almeida the company's Chairman and Chief Executive Officer, effective January 1, 2016.
Biophotonic Solutions Inc., East Lansing, MI, a world leader in automated laser pulse compression, has appointed Dr. Vittorio Fossati-Bellani as its Chief Executive Officer.
Prism Medical Ltd., Toronto, Canada, announced that Andrew McIntyre, its CEO and Executive Chairman, has recently been diagnosed with cancer and will be taking a medical leave of absence for treatment. The Board of Directors named John C. Charles, its Vice Chairman, as Interim CEO during McIntyre’s absence.
AdvaMed (the Advanced Medical Technology Association), Washington, DC, has named Shaye Mandle, CEO of Minnesota’s LifeScience Alley trade association, as chairman of its State Medical Technology Alliance.
Husky Injection Molding Systems, Bolton, Ontario, Canada, a leading global supplier of injection molding equipment and services to the plastics industry,announced the appointment of Randal Levine to the position of Vice President, Finance, and Chief Financial Officer.
MGC Diagnostics Corporation, St. Paul, MN, a global medical technology company dedicated to cardiorespiratory health solutions., announced that Frederic Gavage has been named Managing Director of MediSoft S.A., Sorinnes, Belgium, a wholly-owned subsidiary of MGC Diagnostics.
EnteroMedics Inc., St. Paul, MN, the developer of medical devices using neuroblocking technology to treat obesity, metabolic diseases, and other gastrointestinal disorders, announced that Dan Gladney has been appointed President and Chief Executive Officer.
Merit Medical Systems, Inc., South Jordan, UT, a leading manufacturer and marketer of proprietary disposable medical devices used in interventional and diagnostic procedures, has named Bernard Birkett its Chief Financial Officer, effective immediately.
Expansions/Spinoffs/New Services/Moves
GW Plastics, Bethel, VT, announced the expansion of its Royalton, VT, Manufacturing and Technology Center. GW Plastics plans to break ground later this month on a 21,000 square foot expansion (scalable to 50,000 square feet) to accommodate the additional growth of its thermoplastic and liquid silicone rubber injection molding and medical device contract assembly business.
AtriCure, which manufactures medical devices to treat irregular heartbeats or atrial fibrillation, moved to a new headquarters building in Mason, OH. The $20 million, 92,400 square-foot building will allow the company to expand its workforce.
AccuMed Corp., a contract manufacturer for medical products, specializing in textile-based Class I and Class II medical products that touch the body, is moving its corporate headquarters from Buffalo, NY, to the Triad Region of North Carolina.
Vistek Medical, Ivyland, PA, leading contract manufacturer of medical implants and components focused on the orthopedic, spinal, trauma, and extremity markets, has announced a strategic relocation to Dayton, OH. The move will be effective January 1, 2016.
Phillips-Medisize Corporation, Hudson, WI, a global leader of outsource design, development, and manufacturing services to the medical device industry, announced the completion of a 5,000 sq. ft. expansion to its Hudson Design and Development Center (DDC). This new space will be occupied with expanded biopharmaceutical drug delivery and medical device test engineering capabilities.
TRUMPF Inc., Farmington, CT, a world market and technology leader in fabricating machinery and industrial lasers for flexible sheet metal processing, has purchased five acres of land in Hoffman Estates, IL, for a site that will serve as the future home of the TRUMPF Technology Center and the Center of Excellence for Industry 4.0. The new Technology Center will be the industry-leading facility with a strong focus on integrating automation, material, and information flow with machine tools.
Mergers/Acquisitions/Collaborations/Licensing
Machine Solutions Inc., Flagstaff, AZ,a global supplier of process and testing solutions to the medical device industry, has acquired PlasticWeld Systems, Newfane, NY, which manufactures turnkey, precision production equipment for disposable medical products.
Smith & Nephew, London, UK, a global medical technology business, has agreed to acquire Blue Belt Holdings, Inc., Minneapolis, MN, a global leader in surgical robotics.
Bruker Corporation, Billerica, MA, which provides high-performance scientific research instruments and high-value analytical solutions, announced its acquisition of Jordan Valley Semiconductors Ltd., Migdal Ha´Emek, Israel, a major provider of X-ray metrology and defect-detection equipment for semiconductor process control.
Greatbatch Inc., Frisco, TX, one of the largest medical device outsource manufacturers in the world serving the cardiac, neuromodulation, orthopaedics, vascular, advanced surgical and portable medical markets, announced that it will acquire Lake Region Medical, which makes implantable devices in cardio and vascular and advanced surgical markets.
Resonetics, Nashua, NH, a leader in providing laser micro manufacturing solutions to the medical device and diagnostic industry, announced its acquisition of Mound Laser and Photonics Center, Inc., Kettering, OH, a leader in laser micro manufacturing of precise metal components for the medical device and defense industry.
Lumenis Ltd., Yokneam, Israel, the world's largest energy-based medical device company for aesthetic, surgical, and ophthalmic applications, has completed its acquisition of Pollogen Ltd., Tel Aviv, Israel, a medical aesthetic device company.
STERIS plc, London, UK, a global leader in infection prevention, contamination control, surgical and critical care technologies, has completed its previously announced combination of STERIS Corporation and Synergy Health plc, Swindon, UK, which provides specialty outsourced services to the global healthcare markets, including sterilization services for medical device manufacturers. As a result of the transaction, STERIS Corporation and Synergy are now combined under STERIS.
VISIOMED GROUP, Paris, France, which specializes in advanced electronic medical grade devices, announced the integration of its range of connected health medical devices within Validic, Durham, NC, the leading digital platform for collection of patient data generated from connected mobile health devices.
Galil Medical, Arden Hills, MN, a global leader in cryotherapy ablation solutions, has agreed to acquire Perseon Corporation, Salt Lake City, UT, a provider of medical systems that utilize energy to treat cancer, to create a leader in ablation treatment for both cancerous and non-cancerous tumors.
BIT Group, Irvine, CA, whichprovides contract product development, manufacturing, and after-sales services for life science, medical, and IVD instrumentation OEMs, has established a second comprehensive medical instrument outsourcing manufacturing operation in Shenzhen, China, as a joint venture with EDAN Instruments, Inc., a leader in medical monitoring technology, also in Shenzhen.
CAS Medical Systems, Inc. (CASMED), Branford, CT, a leader in medical devices for non-invasive patient monitoring, announces the sale of assets related to its 740 SELECT® vital signs monitoring product line to Zoe Medical, Inc., Topsfield, MA, a technology leader in the field of patient monitoring, designing, and manufacturing products for major healthcare companies.
MC3 Cardiopulmonary, Dexter, MI, as a spinout of the University of Michigan and a leading developer and manufacturer in the cardiopulmonary device field, has completed its acquisition and transfer of all assets associated with the Surgical Cannula line of Terumo Cardiovascular Systems Corp., Ann Arbor, MI, which develops, manufactures, and distributes medical devices for cardiac and vascular surgery.
Thin Film Electronics ASA, Oslo, Norway, a global leader in printed electronics and smart systems, has announced a partnership with the Ypsomed Group, Burgdorf, Switzerland, a leading developer and manufacturer of injection systems for self-medication. Through the partnership, the companies will collaborate to incorporate Thinfilm’s NFC OpenSense™ technology in the YpsoMate® autoinjector as a means of improving patient self-care compliance.
Miscellaneous
Terason, Burlington, MA, which develops high-performance ultrasound systems, has donated one of its uSmart 3200T portable ultrasound systems to Pope Francis to support the medical capabilities offered by the Vatican Medical Center.
PixarBio Corporation, Cambridge, MA, announced that its cofounder Robert S. Langer was awarded the 2015 Queen Elizabeth Prize (QEPrize), celebrating ground-breaking innovation in engineering and presented by Queen Elizabeth at the Throne Room in Buckingham Palace, London, UK.
Frost & Sullivan, London, UK,a consulting firm that provides market research and analysis, has presented ulrich medical, Ulm, Germany,which producessurgical instruments, spinal implants, and contrast media injectors for diagnostic imaging procedures, with the 2015 European Frost & Sullivan Award for Competitive Strategy Innovation and Leadership.
