Here is the latest batch of news from the medical products community. Please click the link for more.
Regulatory Approvals and Launches
St. Jude Medical, Inc., St. Paul, MN, a global medical device company, has secured CE Mark and FDA clearance for its new OPTISTMIntegrated System, which marks the launch of the world’s first percutaneous coronary intervention optimization system to offer optical coherence tomography and angiography co-registration.
Medtronic, Minneapolis, MN, announced FDA 510(k) clearance of its NC Euphora Noncompliant Balloon Dilatation Catheter to encourage stent apposition to the artery wall.
Breathe Technologies, Irvine, CA, a developer and manufacturer of innovative medical technologies for patients with respiratory insufficiency diseases and neuromuscular diseases, has received the CE Mark for its Non-Invasive Open Ventilation (NIOV) System.
Perkin Elmer, Inc., Waltham, MA, announced the launch of its Solaris™ quantitative optical molecular imaging system to help develop and validate molecular-guided surgical research protocols.
Covidienplc, Dublin, Ireland, announced the expansion of its Sonicision™ Cordless Ultrasonic Dissection Device portfolio, following FDA 510(k) clearance of three additional device lengths: 13 cm, 26 cm, and 48 cm.
Spineology Inc., St. Paul, MN, an innovator in anatomy conserving spine surgeryTM, announced the full release of its VIATM Spinous Process Fixation System, the first and only Spinous Process Plate with independently compressible superior and inferior plates contoured to maximize the fit between the implant and the spinous processes and associated laminae.
Siemens Healthcare, Malverne, PA, one of the world's largest suppliers to the healthcare industry, announced that the FDA has cleared its SOMATOM Scope, a new 16-slice computed tomography scanner.
AtriCure, Inc., West Chester, OH, an innovator in surgical treatments for atrial fibrillation and Left Atrial Appendage Management, has launched the AtriClip® FLEX, with a more flexible aluminum shaft that allows surgeons to better maneuver within a patient’s particular anatomy.
Medrobotics Corp., Raynham, MA, a surgical products company with core competencies in medical robotics, announced the US and European launch of its Flex Retractor® which is designed for robotic and laser microsurgery procedures.
K2M Group Holdings, Inc., Leesburg, VA, a global medical device company focused on designing, developing, and commercializing innovative and proprietary complex spine technologies, announced the launch of its EVEREST® Minimally Invasive Spinal System, a cannulated top-loading polyaxial pedicle screw system.
Specialty Seal Group, Latrobe, PA, a leader in the development of ceramic-to-metal and glass-to-metal hermetic seals, has received ISO 9001:2008 certification.
NK Technologies, San Jose, CA,a leading provider of current sensing, ground fault detection, and power monitoring products to the industrial and factory automation markets, has successfully completed an ISO-9001/ISO-14001 recertification audit of its quality assurance and environmental management systems.
Freedom Innovations, Irvine, CA, a manufacturer of advanced technology prosthetic devices, has officially launched its new Plié 3 Microprocessor Controlled Knee.
MOCON, Inc., Minneapolis, MN, a leading provider of instrumentation and consulting and laboratory services, announced that Darrell Lee will retire as Vice President, Treasurer, and CFO at the beginning of October 2014, and Elissa Lindsoe, has been appointed to those positions, effective October 6.
Sussex Wire, Inc., Easton, PA, has appointed Paul Hnat to the position of Global Account Manager, where his focus will be collaborating with strategic account engineering, sourcing, and quality control teams to identify the best design, manufacturing, and logistics solution for their miniature and micro metal component requirements.
MC10 Inc., Cambridge, MA, a leader in next-generation wearable, flexible, and stretchable electronics, has hired former Broadcom executive, Scott Pomerantzas its new Chief Executive Officer and President.
Wright Medical Group, Inc., Memphis, TN, a specialty orthopaedic company, announced that Kevin D. Cordell has been appointed President, U.S. Extremities, effective September 29, 2014.
Thermo Fisher Scientific Inc., Waltham, MA, a world leader in serving science, has appointed three new members to its Scientific Advisory Board: Dr. Andrea Califano, Dr. Arnold J. Levine, and Dr. Aviv Regev.
ADM Tronics Unlimited, Inc., Northvale, NJ, which designs and manufactures electronic medical devices, has appointed Gianluca DeNovi, PhD, to its corporate Advisory Board for business development.
Sensory Medical Inc., San Clemente, CA, which created a device for restless leg syndrome, has appointed David Baker as its President and Chief Executive Officer.
Connecticut Spring & Stamping, Farmington, CT, a manufacturer of precision parts, announced that it has expanded its capabilities to include fineblanking, ideal for economically producing highly complex, ready-to-install multifunctional parts in medical applications.
Royal Philips, Amsterdam, The Netherlands, announced that it is planning to split the company into two units, separating its healthcare and lighting divisions. The healthcare and consumer lifestyle businesses will combine to form one company, which will be called HealthTech.
Kimberly-Clark Corporation, New York, NY, will launch a spin-off of its healthcare division on November 1. The healthcare business has been named Halyard Health and will be headquartered in Alpharetta, GA.
ADM Tronics Unlimited, Inc., Northvale, NJ, which specializes in electronic medical device design, development, and manufacturing, is expanding its medical device design and engineering capabilities by increasing its staff of engineers and the acquisition of additional rapid 3D prototyping and other equipment.
Victrex plc, Lancashire, UK, and West Conshohocken, PA, a world leader in polyketone manufacturing, has launched a new website that enables visitors to quickly access detailed information about high-performance polymers, save documents to their personal library, and share data with colleagues. Visit www.victrex.com .
Allied Vision Technologies, Stadtroda, Germany, announced its intention to expand its headquarters’ facilities to meet demand for its machine vision cameras. The expansion is expected to be completed in 2015.
Greiner Bio-One GmbH, Frickenhausen, Germany, a technology partner for the diagnostic and pharmaceutical industries and the medical sector, has added a dedicated global sales organization for OEM development and production to its BioScience, Preanalytics, and Diagnostics divisions.
Foster Delivery Science, Putnam, CT, a leader in hot melt extrusion (HME) for pharmaceutical and medical device applications, has broken ground on a new facility to support increased demand for manufacturing drug delivery and implant polymer blends. The new 32,000 square foot facility will be dedicated to HME processing of highly regulated materials and will include an ISO Class 7 cleanroom.
Google Inc., Mountain View, CA, has acquired Lift Labs, San Francisco, CA, a medical technology and device company that manufactures vibrating eating utensils for individuals with tremors.
Integra LifeSciences Holdings Corporation, Plainsboro, NJ, and Medtronic, Inc., Minneapolis, MN, announced an agreement in which Integra will acquire Medtronic's MicroFrance and Xomed manual ENT and laparoscopy instrumentation lines, expected to close in the fourth quarter of 2014. Under the terms of the agreement, Integra will acquire a portfolio of approximately 4,000 MicroFrance and Xomed manual ENT and laparoscopic surgical instruments, as well as the St. Aubin le Monial, France manufacturing facility.
Argon Medical Devices, Inc., Plano, TX, which manufactures medical products and devices for interventional radiology, vascular surgery, interventional cardiology, critical care, and oncology procedures, has acquired Promex Technologies, LLC (d/b/a US Biopsy), Franklin, IN, a manufacturer of soft-tissue biopsy products.
AdvancedCath, Watertown, MA, which develops and manufactures advanced catheter technologies, has acquired LSA Laser, Plymouth, MN, which specializes in laser cutting, laser welding, laser ablation and laser marking and provides precision medical device manufacturing and assembly services to medical device OEMs.
IBA (Ion Beam Applications SA), Louvain-la-Neuve, Belgium, the world's leading provider of proton therapy solutions to treat cancer, announced that it has signed a research collaboration agreement and a technology license agreement to develop ultra-high precision Intensity Modulated Proton Therapy with the University of Iowa, Iowa City, IA. This agreement includes an exclusive license on the Dynamic Collimation System recently developed by the University of Iowa.
Blue Belt Technologies, Plymouth, MN, a medical technology company specializing in robotic solutions for orthopedic surgery, announced a world-wide commercial agreement with DePuy Synthes, Warsaw, IN, the world’s largest provider of orthopaedic and neurologic solutions, to support their SIGMA® HP Partial Knee System on Blue Belt’s Navio® Surgical System, marking the sixth implant system supported on Navio’s open platform software.
Ziehm Imaging, Inc., Orlando, FL, a leading developer, manufacturer, and marketer of mobile C-arm X-ray imaging solutions, has partnered with Christie InnoMed, Inc., Quebec, Canada, a total solutions provider and systems integrator for diagnostic imaging equipment. The exclusive agreement provides Christie InnoMed complete access to Ziehm's array of mobile C-arms.
Connecticut Spring & Stamping, Farmington, CT, a manufacturer of precision parts for the medical, aerospace, firearms, and defense industries worldwide, has launched a “5S” workplace organization process at its manufacturing facilities. The 5S program refers to steps taken to sort, set in order, shine, standardize, and sustain, as part of the company’s lean manufacturing initiatives.
Nordson ASYMTEK, Carlsbad, CA, a leader in fluid dispensing, jetting, and conformal coating technologies, is hosting the “Conformal Coating and Precise Fluid Dispensing Process Technologies Workshop” in Indianapolis, IN, from October 22-23, 2014. For more information, visit www.nordsonasymtek.com/indy .