Here is the latest batch of news from the medical products community. Please click the link for more.
Regulatory Approvals, Standards, and Launches
EOS imaging, Paris, France, a pioneer in 2D/3D orthopedic medical imaging and associated solutions, announced a new online service offering that allows hospitals to outsource 3D modelling from EOS stereo-radiographic images. In addition, the company has received the CE Mark for its kneeEOS, the first 3D planning software for total knee arthroplasty based on EOS bi-planar imaging.
St. Jude Medical, Inc., St. Paul, MN, a global medical device company, announced CE Mark approval and the European launch of the St. Jude Medical Invisible Trial System, an app-based and wireless neuromodulation programming system leveraging Apple™ iPod touch™ and iPad mini™ technology.
Cohero Health, New York, NY, has received FDA 510(k) clearance for its Bluetooth-connected spirometer, which measures lung function comparable to clinical-grade spirometers and sends the data to a smartphone or tablet.
InvisionHeart, Nashville, TN, a leading developer of a disruptive ECG technology with a secure cloud-based, healthcare IT platform, announced that its InvisionECG technology has received FDA 510(k) clearance.
VertiFlex, Inc., San Clemente, CA, a leading innovator of advanced minimally invasive interventions for spinal stenosis, announced that the FDA has issued a PMA Approval Order for its Superion® Interspinous Spacer System, clearing the way for commercialization in the US.
Zecotek Photonics Inc., Richmond, BC, Canada, a developer of leading-edge photonics technologies, announced that the U.S. Patent office has granted a patent for technology related to the company’s switchable 3D/2D optical imaging system.
Rivanna Medical, Charlottesville, VA, has received FDA 510(k) clearance for Accuro, a handheld and untethered device designed to guide a clinician using a needle or probe to a target within the human anatomy.
Medical Informatics Corp., Houston, TX, whch provides data for alarm management and safety, has received FDA 510(k) approval for the company’s Sickbay Clinical Platform™ and three applications: Patient Monitor, Patient Alarm Data, and Alarm Analytics Dashboard.
Carestream Health, Rochester, NY, announced that its Touch Prime ultrasound system and Touch Prime XE ultrasound system, both designed for general diagnostic imaging use in radiology, have received FDA 510(k) clearance.
Cyberonics, Inc., Houston, TX, a medical technology company specializing in neuromodulation, announced that it has received FDA approval for its AspireSR generator designed for vagus nerve stimulation to treat drug-resistant epilepsy.
Benchmark Electronics, Inc., Angleton, TX, a leading integrated contract manufacturing provider, announced that its Nashua, NH, facility was awarded ISO 13485:2003 certification for medical device manufacturing throughout the full product lifecycle.
BioMedical Enterprises, San Antonio, TX, a leader in orthopedic shape memory implant technology, announced the launch of its Speed Triad™ Nitinol Bone Fixation Implant, the world’s first superelastic shape memory bone fixation system with three legs for stable, six-point fixation.
Arch Therapeutics, Inc., Framingham, MA, a medical device company developing a novel approach to stop bleeding and control leaking during surgery and trauma care, obtained data from a preclinical toxicity test for its AC5 Surgical Hemostatic Device™ showing the device was well-tolerated and classified as "not toxic" in a standardized test of systemic toxicity.
Leadership News
Omron Corporation, Kyoto, Japan, announced that Robert (Robb) M. Black has been appointed President and Chief Operating Officer of its Pan-American Automation and Safety business, Hoffman Estates, IL, which provides automation solutions for industrial applications.
NuVasive Inc., San Diego, CA, a leading medical device company focused on spinal surgery solutions, announced that Gregory T. Lucier has been appointed Chief Executive Officer.
JenaValve Technology, Inc., Munich, Germany, and Irvine, CA, a developer, manufacturer, and marketer of next-generation transcatheter aortic valve repair systems, announced the appointment of Victoria E. Carr-Brendel, PhD, as Chief Executive Officer.
TÜV Rheinland, Boxborough, MA, a full-service inspection, testing, and certification company, has appointed Raymond Chlebicki its Medical Sales Manager for North America to expand the group’s market share in the US, Mexico, and Canada.
Solekai Systems, San Diego, CA, a leading provider of custom software development, has appointed Fred Mindermann as Vice President and General Manager of its Connected Health practice.
Coaxial Components Corp., Stuart, FL, which specializes in the manufacture of RF connectors, attenuators, terminations, adapters, torque wrenches, phase adjusters, and cable assemblies, announced that Tana Perry was appointedas the company’s new Marketing Director.
Jenoptik, Jena, Germany, a global leader in laser technology, announced that the company has appointed Klaus Büsselmann as Head of Sales for its Lasers & Material Processing division.
Mazor Robotics Ltd., Caesarea, Israel, a developer of innovative guidance systems and complementary products, has expanded its sales leadership team in the US with the addition of Chad Zaring as Vice President of National Accounts & Strategic Alliances.
Interlink Electronics, Inc., Westlake Village, CA, a global technology leader in Human Machine Interface solutions, announced that Tracy Kern has been appointed Chief Financial Officer.
Expansions/Spinoffs/New Services/Moves
Mouser Electronics, Inc., the global authorized distributor with the newest semiconductors and electronic components, has opened a Japan Customer Service Center, located in Tokyo. Mouser now has 21 offices worldwide, with 8 locations in the Asia Pacific region.
Amada Miyachi America, Inc., Monrovia, CA, a leading manufacturer of welding, marking, cutting, and micro machining equipment and systems, announces that effective July 1, it will take over the management, sales, and service of Amada Miyachi do Brasil Ltda. in all South American markets.
Coastal Life Technologies, Inc., San Antonio, TX, a medical device contract manufacturer specializing in the assembly, packaging, and sterilization of single-use surgical devices, is adding a second ISO Class 8 cleanroom.
MicroVention, Inc., Tustin, CA, a wholly owned subsidiary of Terumo Corporation and a global neurovascular technology company, plans to build a new 205,000 square-foot worldwide headquarters in Aliso Viejo, CA, where the company was originally founded.
Phillips-Medisize Corporation, Hudson, WI, announced the opening of its new design and development center in Suzhou, China, to support its customers’ needs for patient-administered biologics and pharmaceutical drug delivery and diagnostics device design and development services.
Mergers/Acquisitions/Collaborations/Licensing
UL LLC, Northbrook, IL, a global safety science organization, and MasterControl Inc., Salt Lake City, UT, a leading global provider of electronic quality management systems (EQMS) and consulting services, announce a collaborative agreement to support the medical industry with both quality system implementation and comprehensive advice and guidance for successful global regulatory submissions.
Medtronic plc, Dublin, Ireland, a global leader in medical technology, and Samsung Electronics, Ridgefield Park, NJ, a world leader in consumer electronics focusing on transformative mobile health and wellness solutions, announced a new strategic partnership to develop diabetes management products. Their first project focuses on developing mobile applications optimized for Samsung mobile devices that will enable the viewing of insulin pump and continuous glucose monitoring information from Medtronic's MiniMed Connect product.
Cardinal Health, Dublin, OH,a leading manufacturer of medical and surgical products, has purchased Johnson & Johnson’s business Cordis Corporation, Fremont, CA, a global leader in interventional medical devices.
Leica Microsystems, Wetzlar, Germany, a global leader in microscopy and imaging systems, has signed a definitive agreement to acquire Bioptigen, Inc., Morrisville, NC, a technology leader in tomography equipment and software.
Miscellaneous
Amada Miyachi America, Inc., Monrovia, CA, a leading manufacturer of welding, marking, cutting, and micro machining equipment and systems, will be presenting a free symposium, Medical Device Manufacturing—Enable Part Functionality with High Yield, focusing on medical device manufacturing using laser and resistance spot welding. The event will be held in San Jose, Costa Rica, August 11 (in Spanish) and August 12 (in English). For more information, visit http://offers.amadamiyachi.com/medical-device-symposium-rsvp815 .
Proto Labs, Inc., Maple Plain, MN, the world's fastest digital manufacturing source for custom prototypes and low-volume production parts, was named Manufacturer of the Year, Small Enterprise, by Frost & Sullivan’s Manufacturing Leadership Council at the recent Manufacturing Leadership Awards ceremony held in Carlsbad, CA.
TÜV Rheinland, Newtown, CT, a global leader in independent testing, inspection, and certification services, has received the Frost & Sullivan 2015 Customer Value Leadership Award in the category of Electromagnetic Compatibility Testing for North America.
ASCO Sintering Co., Commerce, CA, announced that its sinter-hardened steel planetary gear system, featuring a carrier with an integrated sun gear and three planetary gears, earned the Grand Prize in the Medical/Dental Category at the 2015 Powder Metallurgy Design Excellence Awards Competition, sponsored by the Metal Powder Industries Federation.
The University of Massachusetts at Lowellhas opened a business incubator program aimed at growing startups in the fields of medical devices and technology. The UMass Lowell Innovation Hub and the Massachusetts Medical Device Development Center (M2D2) business incubators opened June 1.
