Here is the latest batch of news from the medical products community. Please click the link for more.
Regulatory Approvals, Standards, and Launches
Merit Medical Systems, Inc., South Jordan, UT, a leading manufacturer and marketer of proprietary disposable devices used primarily in cardiology, radiology, and endoscopy, has received notification of substantial equivalence from the FDA for its Corvocet™ Biopsy System, intended for obtaining core biopsy samples from organs and other soft tissue tumors.
CardiacAssist, Inc., Pittsburgh, PA, which develops, manufactures, and markets novel medical devices, has received FDA 510(k) clearance for its new TandemLung® oxygenator, which acts as an artificial lung to infuse oxygen and remove carbon dioxide from the blood.
Nemaura Medical Ltd., Loughborough, UK, a biomedical diagnostic company, has received a CE mark for its sugarBEAT continuous glucose monitoring system.
Opsens Inc., Quebec City, Canada, which develops, manufactures, and installs fiber optic sensing solutions, announced it has received FDA 510(k) clearance for its OptoWire II, an optical guidewire developed to measure Fractional Flow Reserve used to diagnose the severity of coronary stenosis.
Corindus Vascular Robotics, Waltham, MA, a global technology leader in robotic-assisted percutaneous coronary interventions, has received FDA 510(k) clearance for its CorPath Robotic System for use in peripheral vascular interventions. Previously, the system was cleared for percutaneous coronary intervention and radial PCI.
EOS Imaging, Paris, France, a pioneer in 2D/3D orthopedic medical imaging, announced that the company has received approval from the China Food and Drug Administration to market the EOS system in China; the EOS system can now be marketed in 51 countries.
Varian Medical Systems, Palo Alto, CA, one of the world's leading manufacturer of medical devices and software to treat cancer and other conditions with radiation, has launched its Calypso 17G soft tissue Beacon transponder, which is half the size of its predecessor, and has received both FDA clearance and the CE Mark.
John Evans’ Sons, Lansdale, PA, a manufacturer of industrial springs and mechanical assemblies, has been awarded AS9100C Certification. The company’s other certifications include ISO 9001:2008 and ISO 13485:2003.
TissueGen® Inc., Dallas, TX, the developer of a bioresorbable fiber format for advanced drug delivery, nerve regeneration, and tissue engineering, was awarded ISO 13485:2003 certification following significant investment in its quality management system and upgrades to its research, development, and production infrastructure.
TSO3 Inc., Quebec City, Canada, an innovator in sterilization technology for medical devices in healthcare settings, has received FDA 510(k) clearance for a universal design of its STERIZONE® VP4 Sterilizer.
St. Jude Medical, Inc., St. Paul, MN, a global medical device company, announced CE Mark approval and launch of three new Quartet™ left ventricular leads, offering additional electrode spacing options and one new lead shape.
Direct Flow Medical, Inc., Santa Rosa, CA, a medical device company developing and commercializing transcatheter heart valve therapy products to treat structural heart disease, announced the European commercial market launch of its DirecTrack™ Delivery System, a next-generation delivery system for the Direct Flow Medical Transcatheter Aortic Valve System.
Healionics Corporation, Seattle, WA, which develops and manufactures synthetic biomaterials and implantable medical devices, announced the appointment of Mike Connolly as Chief Executive Officer.
Tandem Diabetes Care, Inc., San Diego, CA, which is involved in the design, development and commercialization of products for people with diabetes who use insulin, announced the appointment of Henry Anhalt, DO, FACOP, FACE, as an independent member of its Board of Directors.
International TechneGroup Incorporated (ITI), Milford, OH, a global leader providing interoperability, validation and migrationsolutions for product data and related systems, announced that Tony Provencal has taken on the newly created position of Technical Sales Director.
Allied Motion Technologies Inc., Amherst, NY, a global designer and manufacturer of motion control products, announced that Kevin McNicholas has joined the company as Vice President of Sales.
International TechneGroup Incorporated (ITI), Milford, OH, and Cambridge, UK, a global leader in interoperability, validation, and migration solutions for product data and related systems, announces the following promotions within the company’s European team: Andy Chinn has been promoted to Commercial Director for the ITI Cambridge UK office; Mark Gammon has been promoted to Technical Director and CADfix Product Manager; and Tina McEwan has been appointed Finance Director.
Halt Medical, Brentwood, CA, which is developing product solutions for women who suffer from symptomatic fibroids, announced that Kim Bridges has been appointed Chief Executive Officer and member of the Board of Directors.
Glebar Company, Ramsey, NJ, a vertically integrated manufacturing company that designs and configures modular machine systemsand precision grinding machines, has opened a new parts distribution facility in Dublin, Ireland, providing 24-hour turnaround for critical machine components for European customers. Glebar plans to open another distribution facility in Costa Rica to service its many medical customers in the region.
LaVezzi Precision, Glendale Heights, IL, a contract manufacturer of high-precision medical, surgical, and dental implants, and instrument components, announced the move of its manufacturingoperations to a brand new, custom-built 90,000 sq. ft. facility in Bloomingdale, IL.
Gordon Brush Mfg. Co., Inc., anISO 9001:2008 certified leading manufacturer of specialty, custom, and standard brushes for industrial and consumer purposes, has moved into its new 183,000 square foot facility in City of Industry, CA.
Baylis Medical, Montreal, Canada, which designs, manufactures, and distributes a diverse range of products with applications in interventional cardiology, electrophysiology and interventional radiology, has announced plans to invest $32.5 million in a new research and development facility in Mississauga, Ontario, Canada.
Canon Inc., Tokyo, Japan, which makes X-ray machines and eye examination devices, is awaiting regulatory approval for its planned acquisition of Toshiba Medical Systems Corp. (TMSC), Tokyo, Japan, the 21st largest medtech business in the world by revenue and the world’s second-largest manufacturer of CT scan machines. TMSC will be spun out into a holding company until the deal is approved.
Boston Scientific Corp., Marlborough, MA, a worldwide developer, manufacturer, and marketer of medical devices, and the Mayo Clinic, Rochester, MN, a nonprofit organization committed to medical research and education, announced a continuing collaboration where the two organizations share intellectual property to stimulate the rapid development of medical devices to address unmet clinical needs.
Advanced Thermal Solutions, Inc. (ATS), Norwood, MA, an innovator and solutions provider for the thermal management of electronics, is now represented by Ismosys (Integrated Sales Marketing and Operations System), Bicester, UK, a European sales resource for leading edge semiconductors and technologies that will represent all ATS products across Continental Europe.
Hexagon AB, Stockholm, Sweden, a leading global provider of information technologies to drive productivity and quality across geospatial and industrial enterprise applications, announced the acquisition of Forming Technology Inc. (FTI), Burlington, Ontario, Canada, a provider of manufacturing software solutions designed to reduce the development time and material costs of sheet metal components.
B. Braun, Melsungen, Germany, one of the world´s leading healthcare suppliers, has reached a long-term distribution agreement with ICU Medical, Inc., San Clemente, CA, which designs, manufactures, and markets proprietary disposablemedicaldevices to contain body fluids, through which B. Braun will market ICU’s SwabCap disinfecting cap for needleless connectors. Under the agreement, B. Braun will gain distribution rights to promote SwabCap in more than 30 countries outside the US.
Fluid Metering, Inc., Syosset, NY, which provides valveless, ceramic piston pumps for precision fluid control, announces that its new2016 Catalog is available on its web site www.fmipump.com in PDF format for immediate download.
SCHURTER Inc., Santa Rosa, CA, a manufacturer of circuit protection, connectors, switches, and EMC products to the electronic and electrical industries worldwide, has upgraded its fuseholder portfolio to meet the new IEC/EN 60127-6 standard, which becomes effective in October 2017.