Here is the latest batch of news from the medical products community. Please click the link for more.
Regulatory Approvals, Standards, and Launches
StimRelieve LLC, Fort Lauderdale, FL, engaged in the development, manufacture, and commercialization of wirelessly-powered, implantable neurostimulators, has received FDA Investigational Device Exemption approval to launch a clinical trial of the world’s smallest percutaneously implantable device to treat chronic migraine.
Svelte Medical Systems, Inc., New Providence, NJ, engaged in the design and development of highly deliverable balloon expandable stents, has won CE Mark certification for its SLENDER sirolimus-eluting coronary stent-on-a-wire integrated delivery system to treat coronary artery disease.
K2M Group Holdings, Inc., Leesburg, VA, a global medical device company focused on designing, developing, and commercializing complex spine technologies, techniques, and minimally invasive procedures, has received FDA 510(k) clearance to market theEVEREST®Minimally Invasive (MI) XT Spinal System, a cannulated top-loading pedicle screw system.
Life Spine, Huntley, IL, a medical device company that designs, develops, manufactures, and markets products for the surgical treatment of spinal disorders, announced that the FDA has given 510(k) marketing clearance to its GRUVE Anterior Cervical Plate System.
ZOLL Medical Corporation, Chelmsford, MA, an Asahi Kasei Group company, has received expanded FDA approval for use of its LifeVest wearable cardioverter defibrillator in some children. The device can now be used in children aged 3 to 17 who are at risk of sudden cardiac arrest but are ineligible for an implantable defibrillator.
Device Solutions Inc., Morrisville, NC, which provides wireless and mobile device consulting, has announced the successful launch by its client and partner FokusLabs, Inc., Wake Forest, NC, of the RE-vibe: The World’s First Anti-Distraction Wristwear, for kids and adults, including those with autism and ADHD.
ReWalk Robotics Ltd., Marlborough, MA, the leading global exoskeleton developer and manufacturer, announced that the U.S. Department of Veterans Affairs has issued a national policy for the evaluation, training, and procurement of ReWalk Personal exoskeleton systems for all qualifying veterans across the United States.
Bio Light Israeli Life Sciences Investments Ltd., Tel Aviv, Israel, an emerging global ophthalmic company focused on the discovery, development, and commercialization of products to address ophthalmic conditions, announced that its IOPtiMate™ system to treat glaucoma has been approved by the Canadian Medical Devices Bureau.
BIOTRONIK, Lake Oswego, OR, a leading manufacturer of cardiovascular medical technology, has received FDA approval for use of its latest family of implantable cardioverter defibrillator systems with magnetic resonance imaging scans.
Cardiac Dimensions, Kirkland, WA, a medical device company addressing functional mitral regurgitation using a minimally invasive approach, announced the appointment of Gregory D. Casciaro as President and Chief Executive Officer. He was also appointed to the company’s Board of Directors.
SurModics, Inc., Eden Prairie, MN, a leading provider of medical device technologies, particularly surface modification coating technologies, announced the addition of Shawn McCormick to its Board of Directors.
Pharm-Olam International Ltd., a multi-national, full-service clinical research solutions organization to the biopharmaceutical and medical device industries, announced the promotion of Natalie Gassen to the position of Chief Financial Officer.
COMSOL, Inc., Burlington, MA, a leading provider of multiphysics modeling, simulation, and application design software, announced the expansion of its office in Shanghai, China, to keep pace with the growing COMSOL® software user base in China and increasing demand for COMSOL Multiphysics® and COMSOL Server™ products. Services in Shanghai include sales, technical support, training sessions, and on-site workshops and customer visits.
Proxy Biomedical Ltd., Galway, Ireland, a global leader in the design, development and manufacturing of biomaterial-based product solutions for medical implants, has announced a substantial facility expansion. The company will double its cleanroom manufacturing facilities, and introduce a suite of new technologies and biomaterial conversion processes.
Phenox, Bochum, Germany, which specializes in producing products that are used to treat ischemic and hemorrhagic strokes, plans to open a new manufacturing facility in Galway, Ireland, in early 2016.
Medtronic plc, Dublin, Ireland, a global leader in medical technology, is set to open a new 20,000 square foot manufacturing facility in Galway, Ireland, to manufacture its IN.PACT Admiral drug-coated balloon to treat peripheral artery disease.
Restoration Medical Polymers LLC, Columbia City, IN, has announced it will be locating its corporate headquarters and manufacturing facility in Whitley County, IN. The company will invest up to $7.1 million for the new 36,000 square-foot facility. The facility is expected to be occupied by late 2016 with production starting in early 2017.
Medtronic plc, Dublin, Ireland, a global leader in medical technology, and Samsung Electronics America, Ridgefield Park, NJ, a global leader in consumer electronics and digital health, announced a broad-based strategic alliance to accelerate the development of digital health solutions for people suffering from chronic pain, movement disorders, incontinence, and other conditions who could benefit from neuromodulation therapy.
Orchid Orthopedic Solutions, Holt, MI, a worldwide leader in design and manufacturing for the orthopedic and medical device industry, has completed its acquisition of the Cam Bioceramics coating facility and operations in Suzhou, China. This acquisition will allow Orchid to offer world-class coating capabilities in the US, Europe, and Asia to its customers, and creates a base for the company to further expand its capabilities in China to serve the growing demands in the market.
Senseonics Holdings, Inc., Germantown, MD, a medical technology company focused on the development and commercialization of long-term, implantable continuous glucose monitoring system, announced the completion of its merger with ASN Technologies, Inc., which develops mobile applications and has changed its name to Senseonics Holdings, Inc.
Cemtrex, Farmingdale, NY, a diversified industrial and manufacturing leader, announced has completed its previously announced acquisition of leading industrial services company, Advanced Industrial Services Inc., and its affiliate subsidiary companies based in York, PA.
Minnesota Medical, Stewartville, MN, and Mayo Clinic, Rochester, MN, will collaborate to refine, clinically test, and bring to market the company's new Advanced Device Technology designed to control and help manage fecal incontinence.
ALPHAEON Corporation, Irvine, CA, a social commerce company and subsidiary to Strathspey Crown Holdings LLC, announced its acquisition of Rocol SA, Barranquilla, Colombia, a leader in the commercialization of medical equipment across Latin America. In addition, ALPHAEON closed on its acquisition of LENSAR, Inc., Orlando, FL, through a wholly owned subsidiary. LENSAR is a commercial stage medical device company providing Femtosecond Laser technology for cataract treatment.
JADAK LLC, Syracuse, NY, part of GSI Group Inc., a global leader and supplier of HF RFID, optical data collection, and machine vision technologies to OEMs in medical, security, gaming and kiosk industries, has acquired the assets of SkyeTek, Denver, CO, a provider of embedded and standalone UHF RFID Solutions for OEM equipment suppliers.
A&D Company, San Jose, CA, a global, multi-industry company engaged in the development, manufacture and sale of precision measurement solutions, has entered into a definitive agreement to acquire the necessary business assets of Auto Control Medical, Toronto, Canada, a distributor of hypertension, diabetes, and respiratory products, which will initially operate as a division of A&D Canada, Inc.
CryoLife Inc., Atlanta, GA, a leading medical device and tissue processing company focused on cardiac and vascular surgery, has entered into an agreement to acquire On-X Life Technologies Holdings, Inc., Austin, TX, a mechanical heart valve company.
FDA has announced the following public workshop titled “Moving Forward: Collaborative Approaches to Medical Device Cybersecurity,” to be held January 20-21, 2016, at the FDA White Oak Campus in Silver Spring, MD. For more information, visit http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm474752.htm
Vallorbs, Bird-In-Hand, PA, a custom precision machining company, has announced a new Eliminating Galling Tip Sheet to help product designers and engineers prevent galling, a form of wear that causes threaded parts to loosen, seize, or prematurely fail. To view the tip sheet, visit http://www.vallorbs.com/wp-content/uploads/2015/12/Eliminating-Galling_Rolled-vs-Cut-Threads.pdf
The IPC APEX EXPO® 2016 technical conference and professional development courses, will take place March 13–17 at the Las Vegas Convention Center in Las Vegas, Nevada. Registration is now open at www.IPCAPEXEXPO.org.
Velmex, Inc., Bloomfield, NY, a manufacturer of linear and rotary motion‐control and positioning equipment for scientific, research, machining, instrumentation, and industrial applications, announces the launch of its new, redesigned website at www.velmex.com, featuring improved navigation and functionality, as well as a consistent presentation of product information across all the Velmex brands.
International TechneGroup Inc. (ITI), Milford, OH, a global leader providing reliable interoperability, validation, and migration solutions to help solve engineering and manufacturing technology problems, introduces a new brand identity and website, unifying the CAD/CAM/CAE Interoperability (C3I) and PLM Integration teams to leverage the strengths of both. In addition, TranscenData Europe Ltd. will change its name to International TechneGroup Ltd.
Stealth.com, Toronto, Canada, a Sparton company, and a leading ISO 9001 manufacturer of industrial rugged computers and peripherals, has launched a new interactive, ecommerce website. Features on the site include enhanced security and optimization for mobile and tablet devices.
Husky Injection Molding Systems, Bolton, Ontario, Canada, a leading global supplier of injection molding equipment and services to the plastics industry, has been recognized with the Ringier 2015 Technology Innovation Award for the development of its Ultra Helix™ valve gate technology and its contribution to production efficiency and cost effectiveness.The award was presented by Ringier Trade Media Ltd.’s International Packaging News for China.