Here is the latest batch of news from the medical products community. Please click the link for more.
Regulatory Approvals, Standards, and Launches
Boston Scientific, Marlborough, MA, a global medical technology leader, has received FDA approval for its SYNERGY Bioabsorbable Polymer Drug-Eluting Stent System to treat coronary artery disease.
Bayer HealthCare, Whippany, NJ, has received FDA approval of its BETACONNECT, the first and only electronic autoinjector to treat relapsing-remitting multiple sclerosis.
Bolton Medical, Sunrise, FL, a subsidiary of the WerfenLife Co., which manufactures and distributes medical diagnostic solutions and medical devices, has received the CE Mark for its Treo Abdominal Stent-Graft System used to treat abdominal aortic aneurysms.
Corindus Vascular Robotics, Inc., Waltham, MA, a leading developer of precision vascular robotics, has received FDA 510(k) clearance for its robotic-assisted CorPath System to be used during percutaneous coronary interventions performed via radial access.
Implanet, Bordeaux, France, has received expanded FDA 510(k) clearance for its Jazz spinal implant, allowing it to be used with other pedicle screw and rod systems for thoraco-lumbar posterior fixation.
UVLrx Therapeutics, Oldsmar, FL, which has developed a unique multi-wavelength therapy system, has received the CEhttp://viterbi.usc.edu/news/news/2015/brain-prosthesis-reencodes-memories.htm Mark to sell its UVLrx 1500 multi-wavelength, intravenous light therapy system in the European Union.
EBR Systems, Inc., Sunnyvale, CA, leading innovator in wireless heart stimulation, has received the CE Mark for its WiSE™ (Wireless Stimulation Endocardially) technology, the world’s only wireless endocardial pacing system for cardiac resynchronization therapy.
SpineGuard S.A., Vincennes, France, which designs, develops, and markets disposable medical devices designed to make spine surgery safer, has received CE mark approval to market its Dynamic Surgical Guidance threaded drill in Europe.
OB-Tools, Migdal Ha’Emek, Israel, a leading innovator in uterine contractions monitoring, has received FDA approval for a fetal heart rate monitoring unit to be used with its new TrueLabor maternal fetal monitor.
HeartFlow Inc., Redwood City, CA, a personalized medical technology company, announced that the U.S. Patent and Trademark Office has issued to HeartFlow its 50th patent.
Hitachi Medical Systems America, Inc., Twinsburg, OH, a provider of diagnostic imaging equipment, has received FDA clearance to market its Supria 16-slice CT system that provides lower dose patient safety capabilities.
Atlas Spine, Jupiter, FL, which focuses on designing and developing minimally invasive spine technologies, has announced the alpha launch of its True Position XL TLIF surgical implant system.
St. Jude Medical, Inc., St. Paul, MN, a global medical device company, announced that the company has received CE Mark approval for its HeartMate 3™ Left Ventricular Assist System, a cardiac support option for advanced heart failure patients who are awaiting transplantation, are not candidates for heart transplantation, or are in myocardial recovery.
Gamma Medica, Inc., Salem, NH, a breast imaging medical device company, has received the CE Mark for its LumaGEM molecular breast imaging system.
Leadership News
AdvaMed (the Advanced Medical Technology Association), Washington, DC, announced that Stephen J. Ubl, President and CEO, has resigned effective today to become president and CEO of the Pharmaceutical Research and Manufacturers of America.
CONMED Corporation, Utica, NY, which provides surgical devices and equipment for minimally invasive procedures, has appointed Nathan Folkert as Vice President and General Manager of its Orthopedics business.
The Joint Commission, Oakbrook Terrace, IL, which accredits and certifies nearly health care organizations and programs in the US, has appointed Brian H. Enochs, JD, to the position of Executive Vice President, Business Development and Marketing.
Nexxt Spine, LLC, Noblesville, IN, focused on designing, manufacturing, and distributing spinal solutions, announced that Bill Del Russo was appointed to Vice President of Sales, George Sims was named as the Central Sales Director, and Mark Medina was named Western Sales Director.
Haemonetics Corporation, Braintree, MA, a global healthcare company dedicated to providing innovative blood management solutions, announced that President, CEO, and Director Brian Concannon has resigned from his role, and Ronald Gelbman, a member of the company’s Board of Directors, has been appointed as Interim CEO.
Cardica, Inc., Redwood City, CA, which designs and manufactures proprietary stapling and anastomotic devices for cardiac and laparoscopic surgical procedures, has appointed Julian Nikolchev as President, Chief Executive Officer and a member of the Cardica Board of Directors.
Minnetronix, St. Paul, MN, a leading medical technology and innovation company, announced that Mark Wagner has joined the company’s Board of Directors.
Merit Sensor Systems, South Jordan, UT, which designs and manufactures piezoresistive pressure sensor solutions, has promoted Scott Sidwell to the position of Sales and Business Development Manager for North and South America.
Corindus Vascular Robotics, Inc., Waltham, MA, a leading developer of precision vascular robotics, has named Gary Lickovitch as Vice President of Sales and Service.
Aortica Corporation, Bellevue, WA, which is focused on the development of innovative treatments for abdominal aortic aneurysms, announced that Shannon Eubanks has joined the company as Vice President of Operations.
Expanite, Hillerød, Denmark, a pioneer in surface hardening of stainless steel, has established a new US subsidiary and treatment center in Twinsburg, OH, and named Christian Dalton as its new North American Sales Manager.
Cook Medical, Bloomington, IN, a global medical device company, regrets to announce that Bill Gibbons, Vice President of Engineering, along with his daughter Abbey, died in a private plane crash.
Expansions/Spinoffs/New Services/Moves
Smiths Medical, St. Paul, MN, a leading global manufacturer of specialty medical devices, plans to open a new corporate headquarters in Plymouth, MN.
Intertek, Allentown, PA, a leading quality solutions provider to industries worldwide, announced the expansion of its analysis services (polymer degradation) for the medical device industry and its suppliers.
Sterigenics International LLC, Oak Brook, IL, the leading global provider of contract sterilization, gamma technologies, and medical isotopes, announced a $15 million expansion at its West Memphis, AR, facility that will triple gamma sterilization capacity to 7.5 million cubic feet. Completion is expected in early 2017.
Para Tech Coating, Inc., Aliso Viejo, CA, a leading provider of vacuum-deposited Parylene technology for nearly 50 years, has opened a new coating center in Neenah, WI, expanding the company’s regional capabilities beyond its California and Connecticut operations.
Mergers/Acquisitions/Collaborations/Licensing
Medtronic plc, Dublin, Ireland, one of the world’s he world's largest medical technology companies, has acquired Lazarus Effect, Campbell, CA, a medical device company focused on acute ischemic stroke products that facilitate the capture and removal of clots. In addition, Medtronic has completed its earlier-declared acquisition of Twelve, Inc., Redwood City, CA, hich is focused on the development of a transcatheter mitral valve replacement device.
St. Jude Medical, St. Paul, MN,a global medical device company, has completed its previously announced acquisition of Thoratec Corporation, Pleasanton, CA, a worldwide leader in mechanical circulatory support technology to treat advanced heart failure.
HTI Technology, Inc., Nashville, TN, has acquired American Control Electronics, LLC, South Beloit, IL. This acquisition will combine HTI Technology’s expertise in AC and DC motor technology and powered mechanism capabilities with American Control Electronics’ technology and market leadership in DC and AC electronic motor drives and controls.
NICO Corporation, Indianapolis, IN, a neurosurgical device manufacturer, has partnered with Hitachi Aloka Medical America, Wallingford, CT, which provides advanced diagnostic ultrasound systems, to provide neurosurgeons real-time, intraoperative imaging to assist with resection when accessing brain tumors using the NICO BrainPath.
Lima Corporate S.p.a., Udilla, Italy, which designs, develops, and manufactures joint replacement/repair solutions, has reached an agreement with Zimmer Biomet Holdings, Warsaw, IN, which designs, manufactures, and markets orthopaedic reconstructive products, to acquire the rights to the Zimmer unicompartmental high flex knee and the Discovery elbow system for the Japanese market.
AtriCure, Inc., West Chester, OH, a leading innovator in treatments for atrial fibrillation, has entered into a definitive agreement to acquire nContact, Inc., Morrisville, NC, a developer of innovative cardiac ablation solutions.
Cardinal Health, Dublin, OH, a leading manufacturer of medical and surgical products, has completed its acquisition of Cordis Corporation, Fremont, CA, the endovascular and cardiology business of Johnson & Johnson.
Averna, Montreal, Canada, an industry-leading developer of test solutions and services for electronics device-makers worldwide, announced that Intel, Santa Clara, CA, one of the world’s largest semiconductor chip makers, has selected Averna’s DP-1000 DOCSIS® Protocol Analyzer to test its DOCSIS 3.1 chipset prior to final certification.
Cardiac Insight, Seattle WA, which develops advanced body worn sensing and computing technologies for applications in the cardiology and respiratory markets, has completed its acquisition of Cardea Associates, Inc., Seattle, WA, a company dedicated to cardiovascular research and product innovation.
ICU Medical, Inc., San Clemente, CA, a leader in the development, manufacture and sale of innovative medical devices used in infusion therapy, oncology and critical care applications, has signed a definitive agreement to acquire Excelsior Medical Corporation, Neptune, NJ, a manufacturer of healthcare devices used to disinfect and protect access into a patient's bloodstream.
Bruker Corporation, Billerica, MA, which supplies high-performance scientific research instruments and high-value analytical solutions, announced has agreed to acquire Jordan Valley Semiconductors Ltd., Migdal Ha’Emek, Israel, which provides a comprehensive portfolio of advanced metrology and defect inspection tools based on X-ray technologies.
ResMed, San Diego, CA, a leader in pioneering devices and treatments for sleep-disordered breathing, chronic obstructive pulmonary disease, and other chronic diseases, has completed its acquisition of Curative Medical, Suzhou, China, a provider of non-invasive ventilation and sleep-disordered breathing medical devices.
Miscellaneous
iWalk (also known as BiOM®), Bedford, MA, a leader in the field of bionic prosthetic devices, announced that the company has relaunched itself as BionX™ Medical Technologies, Inc. to better reflect its commitment to delivering bionic solutions to address critical unmet needs in the market.
Hexagon Metrology, North Kingstown, RI, which offers a range of products and services for all industrial metrology applications, will host an HxGN LIVE Local event from 8:30am to 3:00pm on October 21 at its headquarters location. This open house will highlight innovative technologies in the industrial measurement marketplace. To register, visit www.HexMet.us/LIVELocal/QP15 .
Technoflex, Bois-des-Filion, Canada, a leader in the design and production of flexible containers for injectable solutions, is launching its new website available in French, English, and Spanish, which can now be accessed via tablets and smartphones. Visit www.technoflex.net .
marcus evans, Chicago, IL, the world’s largest event management group, will host the 4th Annual Medical Device Safety Monitoring & Reporting Conference in Las Vegas, NV on January 27-28, 2016. This event will focus on key updates and advancements in medical device safety, medical device reporting, eMDR, post market-surveillance, complaint handling, audit handling and national and international standards.For more information on this conference or to get a complete list of speakers, sessions or past attendees, visit the conference website .
Spine Pain Management, Inc., Houston, TX, a medical device and healthcare solution company servicing the spine injury sector, has changed its name to Spine Injury Solutions, Inc.
