Here is the latest batch of news from the medical products community. Please click the link for more.

Regulatory Approvals, Standards, and Launches

LivaNova PLC, London, UK, a global medical technology company formed by the merger of Sorin S.p.A, a leader in the treatment of cardiovascular diseases, and Cyberonics Inc., a medical device company with core expertise in neuromodulation, announced that the company has received FDA approval for its Perceval Sutureless Heart Valve, the only sutureless surgical aortic valve in the US.

Medtronic plc, Dublin, Ireland, a global leader in medical technology, has received FDA 510(k) clearance for its OsteoCool RF ablation system, which uses targeted high-frequency energy to destroy cancer cells.

Imricor Medical Systems, Burnsville, MN, which specializes in developing devices and systems that are compatible with magnetic resonance imaging (MRI), has received the CE Mark for its Advantage-MR™ EP Recorder/Stimulator System, a first-of-its-kind MR Conditional recording system for MRI-guided electrophysiology procedures.

Edwards Lifesciences Corporation, Irvine, CA, a global leader in patient-focused innovations for structural heart disease and critical care monitoring, announced FDA approval for an expanded indication study of its most advanced transcatheter aortic heart valve, the Edwards SAPIEN 3 valve.

Mach7 Technologies, Burlington, VT, has been awarded a US patent for its iModality mobile application, a handheld medical imaging modality.

Minnesota Rubber and Plastics, Minneapolis, MN, announced that its River Falls,WI, facility has received certification for processing Torlon® PAI, from Solvay Specialty Polymers, the Torlon manufacturer. Torlon has one of the highest tensile strength ratings of any thermoplastic at elevated temperatures up to 525°F, and is designed for use in the most demanding applications.

Olympus, Center Valley, PA, a precision technology leader, announced that it has received FDA 510(k) clearance for its newly designed TJF-Q180V duodenoscope with modifications to the device design and labeling.

W. L. Gore & Associates, Inc., Flagstaff, AZ, which is focused on four main areas—electronics, fabrics, industrial, and medical products—has received FDA 510(k) clearance for its GORE SYNECOR biomaterial for hernia repair, which is composed of three material.

Svelte Medical Systems, New Providence, NJ, which is focused on coronary stenting products, has announced the European launch of its SLENDER sirolimus-eluting coronary stent-on-a-wire integrated delivery system.

CAE Healthcare, Montreal, Canada, a leader in simulation solutions, announced the launch of its NeuroVR™, a neurosurgery simulator that offers what it calls the world’s most realistic training environment for open cranial and endoscopic brain surgery procedures.

HealthMyne, Madison, WI, an imaging informatics company, has secured FDA 510(k) clearance for its analytics software package designed to offer radiologists information in oncology imaging studies.

Advanced Cooling Therapy, Inc., Chicago, IL, whose products work to cool or warm a patient, has received FDA 510(k) clearance to market its second product, the Esophageal Cooling Device (ECD-02), in the US. The ECD technology platform is a temperature modulation device that works through the esophagus.

K2M Group Holdings, Inc., Leesburg, VA, a global medical device company focused on designing, developing and commercializing innovative and proprietary complex spine technologies and techniques, has received a CE Mark for its RHINE Cervical Disc System.

Intuitive Surgical, Inc., Sunnyvale, CA, a global leader in robotic-assisted, minimally invasive surgery, and Trumpf Medical, which develops and produces modern medical equipment for the OR, ICU, and associated clinical areas, a division of Hill-Rom Holdings, Inc., has received FDA 510 (k) approval to offer Trumpf Medical’s Integrated Table Motion for Intuitive’s robotic-assisted da Vinci Xi Surgical System in the US.

Leadership News

InnAVasc, Inc., Durham, NC, a medical device company that designs and develops products for vascular and hemodialysis access, announced that Joseph A. Knight, PhD, MBA, has been appointed President.

Novo Precision LLC, Bristol, CT, which manufactures precision components and builds custom engineered systems for precision wire, cable, and tube processing application, has announced the addition of Richard Mason as Business Development Representative.

Husky Injection Molding Systems, Bolton, Ontario, Canada, a leading global supplier of injection molding equipment and services to the plastics industry, announced the appointment of Stefano Mirti to the position of President, Hot Runners and Controllers. He has been acting interim leader of the Hot Runners and Controllers business since June 2015.

Ivenix, Inc., Amesbury, MA, a medical technology company developing a next-generation infusion management platform, announced the appointment of Stuart A. Randle to Chief Executive Officer.

Tarsus, London, UK, a global media company, has added Chris Young as a strategy consultant for its Additive Manufacturing Shows portfolio and allied information resources.The first edition of Additive Manufacturing Europe 2016 will take place from June 28-30 at RAI Amsterdam, while Additive Manufacturing Americas 2016 will be held on December 7-9 at the Pasadena Convention Center.

Husky Injection Molding Systems, Bolton, Ontario, Canada, a major supplier of injection molding equipment and services, announced the appointment of Dr. Jack Truong as President and Chief Operating Officer, effective February 1.

NSF International, Ann Arbor, MI, a leading provider of regulatory compliance, quality systems, analytical testing, education, and consulting services for the medical device sector, has appointed Kim Trautman as Executive Vice President of International Regulatory Compliance Services for the NSF International Medical Devices group, part of the global NSF Health Sciences Division.

Expansions/Spinoffs/New Services/Moves

Dawar Technologies, Pittsburgh, PA, a manufacturer of projected capacitive (PCAP) and resistive touch screen solutions, has added capital equipment and expanded production capabilities of its manufacturing facility to produce Glass-Film-Film PCAP sensors and optical bonding of touch sensors to liquid crystal displays.

GE Healthcare, Chalfont St. Giles, UK, a global leader in medical imaging and information technologies, medical diagnostics, patient monitoring systems, and more, which moved to the U.K. in 2003, has announced that it will be moving back to the US early in 2016 to new headquarters in Chicago, IL.

Thomas Division of Gardner Denver, Sheboygan, WI, a leader in flow control products for medical, life sciences, and selected other industries, announced the opening of the Thomas Center of Applied Technology (TCAT) facility in Sheboygan, with a 65,000 square foot facility that provides OEMs with systems and value-added services as well as after-market and refurbishment services.

Virtual Incision Corp., Lincoln, NE, which is developing advanced robotically assisted surgical devices and is a spin-pout of the University of Nebraska, will move its operations to the Nebraska Innovation Campus, Lincoln, NE.

MTD Micro Molding, Charlton, MA, a long-time leader in micro-injection molding, has added ultrasonic molding capability to its molding services menu with the purchase of an Ultrasion molding machine.

Technipaq, Inc., Crystal Lake, IL, a provider of flexible and sterilizable packaging design and solutions for the medical device industries, is expanding manufacturing capabilities to offer an expanded range of laminations and coatings for solvent based, water based, as well as solventless adhesives for their unique packaging designs. Overall lamination and coating capacity will more than triple with the laminator expected to be installed Q1 2016.

Coastal Life Technologies, San Antonio, TX, a contract manufacturing outsource provider specializing in the assembly, packaging, and sterilization of single-use surgical devices, is building a new 135,000 square foot headquarters nearly doubling the company’s footprint, with an expansion of 70,000 square feet, including a 12,000 square foot ISO Class 8 clean room.

Mergers/Acquisitions/Collaborations/Licensing

KISCO Ltd., Osaka, Japan, an international supplier of high-quality materials, products, and services, has announced its acquisition of Specialty Coating Systems, Inc., Indianapolis, IN, a global leader in Parylene coating services and technologies. Over the coming year, the merged organization will begin to operate globally as Specialty Coating Systems, a KISCO company.

Molded Devices Inc., Tempe, AZ, a full service molder, has acquired Compass Product Design Inc., Pleasanton, CA, a full service product design and engineering firm offering industrial design, product engineering, prototyping, and production services.

NuVasive, Inc., San Diego, CA, a leading medical device company focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, and Ellipse Technologies, Inc., Aliso Viejo, CA, a medical technology company focused on revolutionizing procedural solutions for complex skeletal deformity, announced that NuVasive will acquire Ellipse.

Katena Products, Denville, NJ, a global provider of precision ophthalmic instruments, biologics, and devices, announces the acquisition of Sensor Medical Technology, Maple Valley, WA, which specializes in the development and manufacture of high quality single-use and reusable procedure lenses used by ophthalmologists and optometrists.

EOS Imaging, Paris, France, a pioneer in 2D/3D orthopedic medical imaging, announced a new partnership with Spinologics, Montreal, Canada, which provides novel medical products that answer unmet clinical needs, to develop a biomechanical simulation software dedicated to spine surgery planning that will be integrated into EOS imaging’s cloud-based, 3D planning software.

CryoLife, Inc., Atlanta, GA, a leader in the manufacturing, processing, and distribution of implantable living tissues and medical devices used in cardiac and vascular surgical procedures, has completed its purchase of On-X Life Technologies Holdings, Austin, TX, a mechanical heart valve company.

The University of Michigan Center for Integrative Research in Critical Care and the U.S. Department of Defense are looking to improve the diagnosis and treatment of severe traumatic brain injury (TBI), and are working together to host The Massey Foundation TBI Grand Challenge, which will allow experts in the field to submit project proposals for funding to address patient needs during the critical 24 to 48 hours of care following a severe TBI. For more information, visit http://www.micircc.org/events/grand-challenge-tbi.

Miscellaneous

NewAge Industries, Southampton, PA, which manufactures plastic and rubber tubing in both reinforced and unreinforced styles, is celebrating ten years as an employee-owned company.

Thomson Industries, Inc., Wood Dale, IL, a leading manufacturer of mechanical motion control solutions, has launched a new, multilingual website that improves access to its extensive library of mechanical motion product and application solutions. For more information, visit www.thomsonlinear.com.

Biologics Consulting, Alexandria, VA, a full-service regulatory and product development consulting firm, has launched a rebranding effort, and is launching its Expert Edge Webinar Series, an interactive, web-based workshop series hosted by its regulatory and product development consultants. For more information, visit www.biologicsconsulting.com.

Mack Molding, Arlington, VT, a leading custom plastics molder and supplier of contract manufacturing services, recently invited local students from the Long Trail School to its plant for an inside look at how business operates as part of the school’s Made in Vermont program.

Custom Sensors & Technologies, Thousand Oaks, CA, is reorganizing following the sale of some of the activities of its portfolio. A new company InnoVista Sensors has been created with the Crouzet Aerospace, Crouzet Automation, Crouzet Control, Crouzet Motors, Crouzet Switches and Systron Donner Inertial commercial brands.

Rogers Corporation, Rogers, CT, announced that its Power Electronics Solutions group, which provides high-power and thermal management materials solutions, is hosting a Design Support Hub available 24 hours a day, 7 days a week, at http://www.rogerscorp.com/designhub.

In response to a growing regional and national skilled labor shortage, GW Plastics, Bethel, VT, a leader in precision injection molding and contract manufacturing, celebrated the graduation of its second “School of Tech” class, which the company began in 2015 after two years of planning with local state and school officials. The semester-long program focuses on raising awareness among local youths about careers in advanced manufacturing. GW Plastics already has plans to expand the program, with the next semester of students starting at the end of this month. The company has also broken ground on its Royalton, VT, site expansion, which will allow for extra classrooms and enhanced training facilities for the students to use.

ndd Medical Technologies, Inc., Andover, MA, a spirometry leader developing pulmonary function testing instruments, is the sole pulmonary function testing sponsor of a new documentary about Leonard Nimoy’s struggle with Chronic Obstructive Pulmonary Disease, called COPD: Highly Illogical–A Special Tribute to Leonard Nimoy. The documentary will be released later this year.

International TechneGroup Incorporated, Milford, OH, announces a one-hour online workshop “Recommendations for Planning, Designing and Implementing Model-Based Design (MBD) / Model-Based Manufacturing (MBM).” This one-hour session will be held February 9. Register for the free online workshop at http://info.iti-global.com/mbd-mbm-webinar-reg?utm_campaign=MBD-MBM%20Webinar%20Feb%202016&utm_source=Press%20Release.