Here is the latest batch of news from the medical products community. Please click the link for more.
Regulatory Approvals and Launches
Intertek, Boxborough, MA, a leading provider of quality and safety solutions, announced that its Boxborough, MA, laboratory is the first lab in North America to receive accreditation to conduct electromagnetic compatibility testing to the IEC 60601-1-2 4th Edition standard for medical products by the IECEE.
BrainScope® Company, Inc., Bethesda, MD, announced that the FDA has cleared the company’s Ahead® 100 device through the de novo classification process.
Covidien plc, Dublin, Ireland, a global health care leader, has received FDA 510(k) clearance for its Fortrex™ over-the-wire percutaneous transluminal angioplasty balloon catheter.
Graphene Frontiers LLC, Philadelphia, PA, a developer of graphene materials and device technology, has been issued U.S. Patent 8,822,308, “Methods and Apparatus for Transfer of Films among Substrates,” which covers the transfer of graphene films between surfaces using roll-to-roll manufacturing processes.
Sanmina Corporation, San Jose, CA, a leading integrated manufacturing solutions company making complex and innovative electronic, optical, and mechanical products, announced that its India Design Center has been awarded the ISO 13485:2003 and EN ISO 13485:2012 certifications for medical product design and development.
Paragonix Technologies, Inc., Braintree, MA, announced it has received ISO 13485:2003 Registration and Certification for its quality management system for the design, development, and manufacture of the Paragonix Sherpa Organ Storage and Transport Systems.
Avantis Medical Systems, Sunnyvale, CA, a medical device company that develops and manufactures catheter-based endoscopic devices, announced that the FDA has cleared its Third Eye Panoramic colonoscopy device for the US market.
COR Medical Technologies, Houston, TX, has appointed Richard N. Agee as its President and Chief Financial Officer. He will assist in the launch of CORcare™, a comprehensive instant outcome support system for rapid and accurate diagnosis, treatment, and follow-up management of patients with acute and chronic, common, and rare diseases involving the cardiovascular system.
Helius Medical Technologies, Inc., Newtown, PA, a medical technology company focused on the treatment of neurological symptoms caused by disease or trauma, announced the appointment of Edward M. Straw as a new Director.
The San Antonio, TX, City Council awarded a $1.75 million grant to the San Antonio Economic Development Corp., to help establish a new medical device company, Covalor Medical LLC, which will work with entrepreneurs to develop and manufacture Class II and Class III medical devices. TheraNova LLC, San Francisco, CA, agreed to relocate three of its startup companies—Perikinetics, Gravitas, and Mimetix Bioengineering to San Antonio and assign ownership of their intellectual property and patent rights to Covalor. In addition, Ardent Biomedical, a San Antonio-based medical device development and commercialization company, plans to transfer ownership of its intellectual property and related assets to Covalor as part of the deal. Both companies will have ownership in Covalor.
Richardson Electronics, Ltd., LaFox, IL, announced today it will be launching its newHealthcare Division. This newly formed strategic business unit will be focused on high quality replacement parts for the diagnostic imaging equipment market.
Noxilizer, Inc., Baltimore, MD, which provides nitrogen dioxide (NO2) based sterilization process for life science manufacturers, has announced an expansion of its contract sterilization operations to meet growing customer demand.
Research centers at UCLA and USC have spun off a standalone company, Carbonics, Inc., Los Angeles, CA, aiming to revolutionize traditional electronics by using carbon-based nanomaterials to lower power consumption and improve the performance of wearable devices.
Hexagon Metrology, North Kingstown, RI, announced the opening of its Fremont Solution Center in Fremont, CA, which includes offices, a training center, and showroom space.
ZOLL Medical Corporation, Chelmsford, MA, a manufacturer of medical devices and related software solutions, has signed an agreement to purchase Philips’ InnerCool™ temperature management business, which includes catheter-based endovascular and surface temperature management technologies.
Tandem Diabetes Care, Inc., San Diego, CA, a medical device company and manufacturer of the t:slim® Insulin Pump, announced a partnership with Tidepool, Palo Alto, CA, a non-profit dedicated to improving diabetes therapy management by offering an open source software platform that increases diabetes data accessibility.
Advanced Cooling Therapy, Chicago, IL, has namedMcArthur Medical Sales Inc., Ontario, Canada, as the Canadian sales distributor for the firm’s first product, the Esophageal Cooling Device.
Versatile Power, Inc., Campbell, CA, a technology leader in the design and manufacture of commercial power supplies and custom electronic subsystems, announces the addition of Sager PowerGate, Santa Clara, CA, to its authorized distributors of Versatile Power’s new family of BENCH Programmable Power Supplies.
Dassault Systèmes, Paris, France, and Waltham, MA, the 3DEXPERIENCE company, announced that its Living Heart project has reached two significant milestones: its first heart simulator has moved into beta and has surpassed 30 contributing member organizations.
Toshiba America Medical Systems, Inc., Tustin, CA, announced that its Dose Tracking System was awarded the coveted Innovative Technology designation by Novation at its Innovative Technology Expo in September.