Here is the latest batch of news from the medical products community. Please click the link for more.
Regulatory Approvals and Launches
Biotronik, Inc., Lake Oswego, OR, a leading manufacturer of cardiovascular medical technology, has received FDA approval for its Ilesto family of implantable cardioverter-defibrillator/cardiac resynchronization therapy defibrillators, and has launched its next generation unique technology platform Ilesto DX in a thinner, smaller device. In addition, the company announced the launch of the new Idova 7 series of implantable cardioverter-defibrillators and ardiac resynchronization therapy defibrillators, which offer ultra-high-energy therapy and longevity of more than 11 years.
Binder Biomedical Inc., Miami, FL, received clearance from the FDA for its LOGIC™, a new stand-alone device composed of a complete anterior lumbar fixation system with a simple, one-step locking mechanism. Alpha release is expected in the first quarter of 2014 with a nationwide launch by the fourth quarter of 2014.
GlobTek, Northvale, NJ, a world-class provider of power supplies and power electronic solutions, now has updated Korean KC Certificates and reports for 24V members of the GT-41080 Series to the latest published standard K 60950-1(2.0)(2011-12), which is required for power supplies to be sold in Korea on their own or as part of a system.
The Verigenics division of NewAge Industries, Southampton, PA, announced that its GammaTagÒ RFID (radio frequency identification) technology has been awarded a US patent (number 8,519,846) to track and identify bags, liners for vessels, filters, medical devices, and pharmaceutical, chemical, and biological processing devices that require gamma irradiation for sterilization purposes.
SuperSonic Imagine, Aix en Provence, France, announced that the Aixplorer® MultiWave™ Ultrasound system, first cleared by the FDA in 2009, has now received FDA clearance for the quantification capabilities of its Real-Time ShearWave™ Elastography.
Globus Medical, Inc., Audubon, PA, a leading musculoskeletalimplant manufacturer, is launching CREO™, its next-generation pedicle screw platform, which provides intuitively designed instrumentation and intraoperative versatility with a complete array of implant options to treat complex spinal pathologies.
Freedom Innovations, Irvine, CA, a manufacturer of advanced technology prosthetic devices, has announced that, through an exclusive worldwide licensing arrangement with Vanderbilt University, it will commercialize and help finalize development of the world’s first fully powered prosthetic leg technology with the potential for the human mind to control its movements.
Nucletron, an Elekta company, Atlanta, GA, received FDA clearance for its Esteya electronic brachytherapy system to treat patients with skin cancer.
Advanced Catheter Therapies, Inc., Chattanooga, TN, an early stage R&D medical device company focused on innovative catheter technologies, announced that its Occlusion Perfusion Catheter™ has received FDA 510(k) clearance.
Olympus, Center Valley, PA, a precision technology leader in innovative diagnostic and therapeutic endoscopy, announced FDA 510(k) clearance and the launch of the world’s only forward-viewing curvilinear ultrasound gastrovideoscope.
Zilico Ltd., Manchester, UK, has received EC certification for ZedScan I, a cervical cancer diagnostics device that uses electrical impedance spectroscopy technology.
Plastics Color Corp., Calumet City, IL, introduced its Mi Batch™ line of particle taggants to combat counterfeit materials and products and impart an extremely high level of security and verification to medical products.
K2M, Inc., Leesburg, VA, the largest privately held spinal device company in the world, announced the launch of the SANTORINI® Small Corpectomy Cage System, designed to address collapsed, damaged, or unstable vertebral bodies resulting from trauma or tumor indications.
Covidien, Mansfield, MA, a leading global provider of healthcare products, launched two advanced energy devices, the LigaSure Impact™ curved large jaw open sealer/divider LF4318 and LigaSure™ blunt tip laparoscopic sealer/divider LF1637. Both devices received FDA 510(k) clearance earlier this year and are suited for colorectal, general, gynecologic, urologic, and thoracic surgery.
DePuy Synthes CMF (Craniomaxillofacial), a leader in skeletal and soft tissue repair and reconstruction and part of the DePuy Synthes Companies of Johnson & Johnson, announced the launch of TRUMATCH® CMF Solutions for facial reconstruction, orthognathic surgery, distraction and cranial reconstruction.
Brainlab, Munich Germany, a leading software technology company, announced FDA 510(k) clearance to market Airo® Mobile Intraoperative CT in the US. The FDA clearance was received by Mobius Imaging®, LLC, the developer and manufacturer of Airo Mobile Intraoperative CT on September 26, 2013.
Sotera Wireless, Inc., San Diego, CA, announced that the FDA has cleared its patented continuous non-invasive blood pressure technology, a new feature of the ViSi Mobile® wireless patient monitoring system to monitor all patient vital signs without the use of a catheter or blood pressure cuff.
Crospon, Galway, Ireland, has received FDA clearance for its EsoFLIP® balloon dilation catheter. This is the first product in what will be a suite of dilation catheter products to be used for dilation procedures in the esophagus and colon.
Invuity®, San Francisco, CA, a developer of advanced visualization devices to transform minimally invasive and minimal access surgeries, announced the full commercial launch of the Eigr™ Saber Waveguide with Yankauer, a handheld illuminator that projects thermally cool, brilliant, white light uniformly throughout the surgical cavity, with the added benefit of a traditional Yankauer suction platform.
Neuros Medical, Inc., Cleveland, OH, a medical device company, has received an Investigational Device Exemption approval from the FDA allowing it to commence a pivotal clinical trial to evaluate the Company’s patented Altius™ System High Frequency Nerve Block technology to manage intractable limb pain of amputees.
MAQUET Medical Systems USA, Wayne, NJ, announced that the FDA granted 510(k) clearance for its VOLISTA Surgical Lighting System, which the configuration of equipment to meet the needs of the procedure.
X-spine Systems, Inc., Miamisburg, OH, a leader in the design and manufacture of devices to treat spinal disease, announced the market launch of three recently FDA-cleared spinal implant systems: the IRIX-C™ cervical integrated interbody fusion system, the AXLE-X™ extended angle interspinous fixation system, and the SILEX™ sacroiliac joint fusion system.
Leadership News
Pulse Systems, Concord, CA, a provider of precision laser machining of tubular metal components for the medical device industry, announced the addition of two key personnel: Brett Poole as Director of Operations, and Wen Ho, PhD, as Senior Manufacturing Engineer for Laser Processing.
Fine Tubes, Plymouth, UK, a leading manufacturer and global distributor of precision tubes for critical applications, is delighted to announce the appointment of Graham Maxa as the company’s new Finance Director.
Secant Medical, Inc., Perkasie, PA, appointed Jeff Robertson as president. He most recently served as vice president, strategic business development.
Rick Valencia, vice president and general manager of Qualcomm Life, Inc., San Diego, CA, a subsidiary of Qualcomm Incorporated is the keynote speaker for INNO-VENTION 2013—a Medical Main Street Conference, to be held November 6-8 at the Troy Marriott Hotel. The conference focuses on how information technology is fueling changes in health care and its impact on the next generation of medical devices. See http://www.MedicalMainStreet.org .
Expansions/Moves
Minnetronix, St. Paul, MN, a leading medical devicedesign,manufacturing,andIPinnovation services firm, announced the expansion of its corporate headquarters, bringing the firm’s total space to just over 120,000 sq. ft. The addition of a 65,000 sq. ft. facility represents the third expansion within seven years to accommodate the company’sgrowth.
NuSil Technology LLC, Carpinteria, CA, introduced a new stocking warehouse in Rotterdam, Holland, and shipments of NuSil silicone have already commenced from the facility.
FATHOM™, Oakland, CA, the area’s largest 3D printing and rapid prototype production center and top performing Stratasys 3D printer distributor of Northern California and Pacific Northwest, announced that its Washington-based offices are moving to a new Seattle location and will include a robust 3D printing production center.
MSC Industrial Supply Co., Melville, NY, a leading distributor of metalworking and maintenance, repair and operations solutions, services, and supplies to industrial customers throughout the US and Canada, announced the grand opening of its co-headquarters in Davidson, NC.
Mergers/Acquisitions/Collaborations
St. Jude Medical, Inc., St. Paul, MN, a global medical device company, announced the completion of its acquisition of Nanostim, Inc., Sunnyvale, CA, a developer of miniaturized, leadless pacemakers, and culminates a two-year partnership between the two companies during which St. Jude Medical invested in and collaborated with Nanostim throughout its product development and commercialization initiatives.
Integra Technologies, Wichita, KS, a leader in integrated circuit test and related services, has acquired Analytical Solutions Incorporated, Albuquerque, NM, which provides product evaluation services through destructive physical analysis, construction analysis, failure analysis, non-destructive testing and counterfeit device investigation of semiconductor devices.
Analogic Corporation, Peabody, MA, enabling the world's medical imaging technology, has acquired the remaining ownership stake in PocketSonics, Inc., Charlottesville, VA, a privately held ultrasound technology firm. Analogic has held a minority equity position in PocketSonics since 2010.
Merit Medical Systems, Inc., South Jordan, UT, a manufacturer and marketer of proprietary disposable devices, has acquired the assets of Radial Assist, Roswell, GA, as well as two products—the SAFEGUARD® Pressure Assisted Device and the AIR-BAND™ Radial Compression Device—from Datascope Corp., Mahwah, NJ.
Biomet, Inc., Warsaw, IN, a global leader in the manufacture of musculoskeletal and biotechnology products, announced today that it has reached a definitive agreement to acquire Lanx, Inc., Broomfield, CO, a full service spine company and a leader in minimally invasive techniques and technologies.
MAKO Surgical Corp., Ft. Lauderdale, FL, has completed the acquisition of the Pipeline Biomedical Holdings, Inc., Cedar Knolls, NJ, business dedicated to the design, development, manufacture, and commercialization of orthopedic devices and instruments for use with both robotic devices and manual medical procedures.
MedPlast Inc., Tempe, AZ, a technology and innovative process leader in manufacturing support for healthcare markets, has acquired Orthoplastics, Ltd., Lancashire, UK, a custom manufacturer of ultra-high molecular weight polyethylene products and components for the orthopedic device implant market.
AngioDynamics, Latham, NY, a leading provider of innovative, minimally invasive medical devices for vascular access, surgery, peripheral vascular disease, and oncology, has signed a sole-source, three-year port product agreement with the Large Integrated Delivery Network Group—formed by eight IDNs from large Premier, Inc. member healthcare systems, in order to transform supply chain services.
Miscellaneous
Phillips-Medisize announced that its Design Development Center in Hudson, WI, has been recognized by the Wisconsin Department of Natural Resources (DNR) for its environmental excellence, making that facility part of its Green Tier Program. Now, all of the Phillips-Medisize facilities located in Wisconsin hold this distinction. Under the Green Tier program, companies work with the DNR and voluntarily commit to environmental performance standards that go beyond regulatory compliance to the highest standards of sustainability, while continuing to achieve specific waste and energy reduction goals, as well as, recycling and technological innovations for environmental protection.
Seco Tools, Troy, MI, a leading provider of metalcutting solutions, has been named as one of “Michigan’s Best and Brightest in Wellness” for 2013, an award presented annually to organizations that are making their workplaces, their employees, and the community a healthier place to live and work. The award was presented by the Michigan Business and Professional Association, Wellco, Corp! magazine, and the Michigan Food and Beverage Association.
Gordon Brush Mfg. Co., Inc., Commerce, CA, an ISO 9001:2008 certified and leading manufacturer of specialty, custom, and standard brushes,has received a Certificate of Appreciation from the California State Assembly for providing quality American-made products.
The FDA’s Office of Orphan Products Development has awarded a grant of up to $1.5 million over five years to the Southern California Center of Technology and Innovation in Pediatrics, a consortium established byChildren’s Hospital Los Angelesand the University of Southern California, to develop pediatric medical devices.
Nanobiosym Health RADAR, a Boston-based research incubator institute led by Dr. Anita Goel, was awarded the $525,000 Grand Prize in the first competition of the Nokia Sensing XCHALLENGE for their Gene-RADAR® sensing technology, which analyzes a drop of blood, saliva, or other body fluid placed on a nanochip and inserted into a mobile device detecting the presence or absence of a disease’s pathogen in less than an hour.
For the ninth season, igus, East Providence, RI, is serving as a nationwide product sponsor for the 21st annual BEST™ Robotics competition. Regional semi-finals will begin in November. BEST (Boosting Engineering Science and Technology) Inc., is a non-profit, volunteer organization that aims to inspire middle and high school students to pursue careers in engineering, science, and technology. For more information about the BEST Robotics competition, visit www.bestinc.org .
InfinityQS International, Inc., Fairfax, VA, an authority on manufacturing intelligence and enterprise quality, has released an eBook, the “Zen Guide to Manufacturing Intelligence,” which provides insight into how to use reporting, statistical analysis, visual summaries, and manufacturing intelligence to attain more value from operational data. To download the eBook, visit: http://www.infinityqs.com/ZenGuide/PR .
Digicom Electronics, Inc., Oakland, CA, a technology and quality driven electronics manufacturing services company, will be hosting a special Sustainable Business Alliance "Green Electronics" event on October 29. To register, visit www.digicom.org/events-mixer-SBA.html.
RPMC Lasers, Inc., Ofallon, MO, is celebrating its tenth year in business, and now offers more than 1,500 lasers and laser diode products.
Applied Silicone Corporation, Santa Paula, CA,a global supplier of implantable silicone material, rolls out a new tagline “Where Science Meets Silicone,” website, and improved e-commerce store. To learn more, visit www.appliedsilicone.com .
Benvenue Medical, Inc., Santa Clara, CA, a developer of minimally invasive solutions for spine repair, won the 2013 Spine Technology Award, presented by Orthopedics This Week, in the minimally invasive spine care category for its Kiva VCF Treatment System
C&A Tool, Churubusco, IN, and WITHIN, New York, NY, have launched a patient-specific, metal-implant design and manufacturing program called WITHIN Medical. The service combines free downloadable software at www.withinlab.com/medical/register.php , developed by WITHIN, and additive manufacturing technology via Direct Metal Laser Sintering from EOS .
