Here is the latest batch of news from the medical products community. Please click the link for more.
Regulatory Approvals, Standards, and Launches
Toshiba America Medical Systems, Inc., Tustin, CA, has received FDA clearance for its Infinix 4D CT with Aquilion Prime CT system configuration, to deliver real-time CT images during procedures. This expands the company’s integration between interventional labs and CT technology.
Boston Scientific Corporation, Marlborough, MA, has received FDA approval for its WATCHMAN Left Atrial Appendage Closure Device, a new stroke risk reduction option for high-risk patients with non-valvular atrial fibrillation. In addition, the company says that it has received FDA and CE Mark approval for its EMBLEM Subcutaneous Implantable Defibrillator System.
DePuy Synthes Companies, West Chester, PA, of Johnson & Johnson has launched the TFN-ADVANCED™ Proximal Femoral Nailing System, a nail, blade and screw system designed to improve patient outcomes by more closely matching the anatomy of patients undergoing hip fracture surgery.
Etiometry, Boston, MA, a pioneering developer of software to improve patient outcomes and reduce the cost of care in intensive care units, has received FDA 510(k) clearance for its T3 Monitor™ product, a software-only solution that aggregates data from multiple sources including bedside patient monitors and devices.
Silver Bullet Therapeutics, Inc., San Jose, CA, which develops antimicrobial implants, has received the CE Mark for commercial sale of its antimicrobial OrthoFuzlon Cannulated Bone Screw System, for orthopedic reduction and internal fixation procedures in the European Union.
Semler Scientific, Inc., Portland, OR an emerging medical risk assessment company that develops, manufactures, and markets products that assist healthcare providers in monitoring patients and evaluating chronic diseases, has received FDA 510(k) marketing clearance for its next generation peripheral artery disease testing system.
BIOTRONIK, Lake Oswego, OR, a leading manufacturer of cardiovascular medical devices, announced that the FDA has approved its ProMRI® Eluna pacemaker system, which allows patients to undergo full-body MRI scans with pacemakers when implanted with Setrox pacing leads.
STI Electronics, Inc., Madison, AL, an electronics manufacturer providing training services and materials, analytical and failure analysis, prototyping, and small- to medium-volume PCB contract assembly, was awarded an IPC J-STD-001, IPC-A-610, and IPC J-STD-001 Space Addendum Qualified Manufacturers Listing.
Voyant Health, Columbia, MD, a Brainlab Company, announced today that it has received FDA clearance on TraumaCad® Mobile, the mobile solution for pre-operative orthopedic surgical planning and digital templating.
NovaBone Products, Jacksonville, FL, a leading biologics bone graft device company, has received FDA 501(k) clearance for its collagen wound dressings.
DJO Global, Inc., Vista, CA, a global provider of medical device solutions for musculoskeletal health, vascular health, and pain management, is launching its new Exprt™ Precision System for highly proficient revision knee surgeons.
EchoPixel, Mountain View, CA, has received FDA 510(k) clearance of its True3D Viewer, the first platform to convert anatomical data from patients into fully interactive, three-dimensional virtual reality images.
Leadership News
Nordson ASYMTEK, Carlsbad, CA, a Nordson company, a global leader in dispensing, jetting, and coating equipment and technologies, announces the expansion and restructuring of its Americas sales team. Brad Perkins has been promoted to General Manager, Americas, for Nordson ASYMTEK. Terry Wilde has taken on the position of Regional Sales Manager, Mexico, and Chris Heesch is District Sales Manager for the Southwestern USA.
The Medical Imaging & Technology Alliance, Arlington, VA, a division of the National Electrical Manufacturers Association (NEMA), has appointed Megan Hayes to serve as its regulatory and standards director.
Benvenue Medical, Inc., Santa Clara, CA, a developer of minimally invasive solutions for spine repair, announced that John Dahldorf has joined the company as Chief Financial Officer.
Agilent Technologies Inc., Santa Clara, CA, announced that Mike McMullen, President and Chief Operating Officer of the company, has been elected Chief Executive Officer by its board of directors, effective immediately.
Apollo Endosurgery, Inc., Austin, TX, a leader in minimally invasive endoscopic surgical products for bariatric and gastrointestinal procedures, has appointed Stefanie Cavanaugh as Chief Financial Officer.
COR Medical Technologies, Houston, TX, which offers CORcare™, a comprehensive instant decision support system for rapid and accurate diagnosis, treatment, and follow-up management of patients with acute and chronic diseases involving the cardiovascular system, announced that Debra J. Barksdale, PhD, FNP-BC, FAANP, FAAN, has been appointed to its Senior Editorial Board.
EOS, Novi, MI, the global technology and market leader for high-end Additive Manufacturing solutions, announced that Glynn Fletcher has been named President of EOS of North America, Inc.
PENTAX Medical, Montvale, NJ, a healthcare industry leader in endoscopic imaging, announced that David Woods, the current President of PENTAX Medical of the Americas, has been appointed as the new global Chief Marketing Officer to oversee product strategy, business development, and branding and communications.
InvisionHeart, Nashville, TN, a healthcare IT company developing an advanced 12-Lead ECG solution, has hired Melanie R. Varin as Executive Vice President, Sales and Marketing.
Urologix Inc., Minneapolis, MN, which develops, manufactures, markets and distributes minimally invasive medical products to treat benign prostatic hyperplasia, has hired Scott M. Madson as its Chief Financial Officer.
Helius Medical Technologies, Newtown, PA, a medical technology holding company that develops, licenses, and acquires non-invasive treatments for neurological disorders, has appointed Jonathan Sackier, MD, as Chief Medical Officer.
Expansions/Spinoffs/New Services/Moves
Clippard Instrument Laboratory, Cincinnati, OH, has responded to increased demand for stainless steel cylinders by expanding its Continuous Flow Manufacturing process at its Cincinnati production facility, enabling thousands of sizes to be guaranteed “Wrapped & Ready” for same day shipping.
Varian Medical Systems, Inc., Palo Alto, CA, a leader in radiotherapy systems and software to treat cancer, is expanding in North Africa with the creation of a strategic operating entity called Varian Medical Systems Algeria SPA located in Algiers.
Infinity LTL Engineered Compounds, Morrisville, PA, a global manufacturer of custom compounded engineered thermoplastics, has constructed a clean compounding site at its Swedesboro, NJ, plant to assist customers in the medical device industry. The 5,000-square-foot site includes an extruder and auxiliary equipment with a capacity of 1.5 million pounds per year.
Clariant International Ltd., Muttenz, Switzerland, a world leader in specialty chemicals, has inaugurated a new manufacturing facility, acquired through its recent acquisition of healthcare packaging company VitaPac. The Dongguan plant, in southeast China, will enhance Clariant’s existing portfolio of controlled atmosphere packaging solutions.
Mergers/Acquisitions/Collaborations/Licensing
Heraeus Medical Components, St. Paul, MN, a leader in precious metals, materials and technologies, sensors, biomaterials and medical products, has acquired NeoMetrics, Plymouth, MN, which specializes in designing and manufacturing guide wires and components for medical devices.
3M, St. Paul, MN, a global innovation company, has completed its acquisition of Ivera Medical Corp., San Diego, CA, a manufacturer of health care products that disinfect and protect devices used for access into a patient’s bloodstream.
Sparton Corporation, Schaumburg, IL, a provider of complex and sophisticated electromechanical devices with capabilities that include concept development, industrial design, design and manufacturing engineering, production, announced that its wholly owned subsidiary, Sparton of Canada, Ltd. Has completed the acquisition of Stealth.com Inc., Woodbridge, Ontario, Canada, a build-to-order, specialty configurator of high performance ruggedized industrial grade computers systems and peripherals.
Whole You, Inc., San Jose, CA, a Mitsui Chemicals company dedicated to providing innovative solutions that allow those with sensory and physical mobility challenges to live life to the fullest, has acquired oral appliance company Respire Medical, Brooklyn, NY.
The Society of Plastics Engineers, the Plastics Innovation and Resource Center of Penn College of Technology, and Paulson Training Programs, Inc., Chester, CT, have entered into an alliance to offer plastics professionals and companies a resource for educational information, training programs and certifications. Paulson will be supplying training in several formats including online, CD-based and seminars through the Paulson Plastics Academy and ProMolder Certification.
Versatile Power, Inc., Campbell, CA, a technology leader in the design and manufacture of commercial power supplies and custom electronic subsystems, has added Instrument Engineers, San Diego, CA, to its authorized distributors of Versatile Power’s new family of BENCH Programmable Power Supplies.
ICON plc, Dublin, Ireland, a global provider of solutions and services to the pharmaceutical, biotechnology, and medical device industries, is sponsoring a series of research projects at Carnegie Mellon University, Pittsburgh, PA, to find new ways to improve information comprehension and retention by clinical trial participants.
Sorin S.p.A., Milan, Italy, a global medical device company and a leader in the treatment of cardiovascular diseases, has signed a merger agreement with Cyberonics, Inc., Houston, TX, a medical technology company focused on neuromodulation.
Miscellaneous
Mack Molding, Arlington, VT, announced that its Southern Division, with plants in Inman, SC, and Statesville, NC, has been chosen as one of four recipients of the 2015 South Carolina Manufacturing Excellence Awards to be presented in April.
IlluminOss Medical, East Providence, RI, a commercial stage medical device company focused on minimally invasive orthopedic fracture repair, announced that the first patient has been enrolled at Albert Schweitzer Hospital in the Netherlands as part of its EU Light Fix Proximal Humerus Fracture Repair Trial to treat osteoporotic and fragility fractures.
