Here is the latest batch of news from the medical products community. Please click the link for more.
Regulatory Approvals and Launches
GE Healthcare, Wauwatosa, WI, announced FDA approval of SenoClaire*, GE’s new breast tomosynthesis solution designed with 3D imaging technology andhalf the radiation dose of all other 3D screening tech on the market. In collaboration with Massachusetts General Hospital, GE developed the SenoClaire technology, which uses a low-dose short X-ray sweep around the positioned breast with nine exposures acquired with a “step-and-shoot” method, removing potential motion from the tube to reduce blur and increase image sharpness.
Medtronic Spinal, Memphis, TN, has received FDA 510 (k) clearance for its Shilla Growth Guidance System, which can be used to treat pediatric patients with severe forms of scoliosis.
Nonin Medical, Minneapolis, MN, received FDA 510(k) clearance to market its Model 3231 finger pulse oximeter, which plugs into a telemedicine hub or kiosk via a USB cord.
CardiacAssist, Pittsburgh, PA, announced the launch of its PROTEK DuoTM veno-venous cannula, following receipt of FDA 510(k) clearance. The device is intended for use as a single cannula for draining and reinfusing blood during extracorporeal life-support procedures.
Ortho Development, Draper, UT, has received FDA 510(k) clearance and will begin the first hip replacement surgeries with its Alpine hip stem this month.
Exostar, Herndon, VA, providing cloud-based solutions that enable secure, cost-effective information sharing and collaboration among healthcare, pharmaceutical, and other industries, was approved as a Full Service Credential Service Provider by the SAFE-BioPharma Trust Framework.
Abbott Laboratories, Abbott Park, IL, has received the CE Mark for its FreeStyle® Libre Flash Glucose Monitoring System, a wearable glucose sensing technology for people with diabetes.
Esaote North America, Inc., Indianapolis, IN, has received FDA 510(k) approval for its MyLab Six ultrasound system, which can be used in applications ranging from cardiovascular and musculoskeletal to ob-gyn and general imaging.
Otoharmonics, Protland, OR, has received FDA 510(k) clearance for its Levo System to temporarily relieve symptoms of tinnitus.
CardiacAssist, Inc., Pittsburgh, PA, has received FDA 510(k) clearance for its new PROTEK Duo veno-venous cannula, intended for use as a single cannula for both venous drainage and reinfusion of blood during extracorporeal life support procedures.
Mazor Robotics Ltd., Caesaria, Israel, a developer of innovative guidance systems and complementary products, announced that the China Food and Drug Administration has approved the company's Renaissance® system, a surgical guidance system for surgeons conducting spine surgeries.
Boyd Corporation, Modesto, CA, a global provider of precision-engineered, specialty material-based energy management and sealing solutions, announced that its Modesto operation has achieved ISO 13485:2003 certification for medical devices.
Intertek, Boxborough, MA, a leading provider of quality and safety solutions, announced that it has gained approval from the American Association for Laboratory Accreditation for expanded testing and certification services.
Olympus Medical Systems Group, Center Valley PA, a global technology leader, has launched its FDA 510(k) cleared QuickClip Pro, a hemostasis clip for use during GI endoscopy procedures.
Cordis Corporation, Fremont, CA, launched its INCRAFT® AAA Stent Graft System, an ultra-low profile device for use during endovascular aneurysm repair for patients suffering from infrarenal abdominal aortic aneurysms.
Mack Molding, Arlington, VT, a leading custom plastics molder and supplier of contract manufacturing services, announced that Jeff Somple, President, Mack Molding Northern Division, has been named President of all of Mack Molding. He will be responsible for both its northern and southern divisions, including five manufacturing facilities; Mack Prototype, a prototyping and low-volume manufacturing facility in Massachusetts; and Synectic, an engineering services group in Connecticut.
Polyonics, Inc., Westmoreland, NH, recently announced the hiring of Jim Clemente to the position of Vice President Global Sales where he will be responsible for growing the company’s global label, tape, and substrate businesses.
GI Dynamics, Inc., Lexington, MA, the developer of EndoBarrier®, the first endoscopically-delivered device approved to treat type 2 diabetes/obesity, has appointed Michael D. Dale as President, CEO, and member of the Board of Directors of GI Dynamics, effective September 18, 2014.
Electromed, Inc., New Prague, MN, which manufactures, markets, and sells products that provide airway clearance therapy, announced that Lee Jones was elected to its Board of Directors.
Cure Care Inc., San Diego, C A, a medical device company that delivers advanced solutions for healing chronic wounds using Vaporous Hyperoxia Therapy, has appointed Dr. Joseph Kurt Bivens as its new Medical Director.
BIOLASE, Inc., Irvine, CA, a leading manufacturer and distributor of dental lasers, announced that Dr. Alexander K. Arrow has been named to the newly-created position of Chief Medical Officer.
Aerodyne Alloys, LLC, South Windsor, CT, announced that Mike Mills has joined in the position of Territory Manager for the company’s Southeastern Region, based in Greenville, SC.
Varian Medical Systems, Palo Alto, CA, broke ground on new construction that will expand its current Salt Lake City, UT, manufacturing facility and allow it to consolidate operations outside of Utah to create 1,000 new jobs over the next 20 years.
A&D Medical, San Jose, CA, a leader in connected health and biometric measurement devices and services, has partnered with Salutron, Fremont, CA, an industry leader in wearable heart rate, activity, and automatic sleep monitoring technology. Through the partnership, A&D Medical is offering Salutron’s LifeTrak family of Bluetooth Smart® activity trackers as a core component of its platform and connected devices.
DuPont Protection Technologies, Wilmington, DE, a global leader in innovative products, materials, and services, announced completion of the sale of its DuPont™ Sontara® business to Jacob Holm & Sønner Holding A/S, Basel, Switzerland, a leading company for spunlaced nonwoven fabrics.
Averna, Montreal, Canada, an industry-leading developer of test solutions and services for communications and electronics device-makers worldwide, has acquired Cal-Bay Systems, San Rafael, CA, a provider of test systems, test and measurement solutions, automated testing, and vibration monitoring tools.
Technipaq Inc., Crystal Lake, IL, ISO 9001/13485 certified, and one of the leading manufacturers of flexible and sterilizable packaging solutions for the medical device industry, is celebrating its 30th anniversary.
S and Y Industries, Inc., Winfield, KS, which provides electronics contract manufacturing services, including thru-hole, SMT and BGA assembly, wire harnesses, box-builds, and engineering design services, is also celebrating its 30th anniversary.
IPC—Association Connecting Electronics Industries®, Bannockburn, IL, has released revisions of two widely used standards, IPC J-STD-001, Requirements for Soldered Electrical and Electronic Assemblies, and IPC-A-610, Acceptability of Electronic Assemblies. The documents have been updated to include technical advances in solder on plastic surface mount components, new criteria for P-style and solder-charged Butt/I SMT terminations, a change to void criteria for BGAs, and enhancements to the language within the documents.
DfR Solutions, Beltsville, MD, a leader in quality, reliability, and durability research and consulting for the electronics industry, announced that Sherlock Automated Design Analysis™ software package library now recognizes the IPC-7351B naming convention for standard SMT land patterns and the working draft of IPC-7251 for thru-hole land patterns.
GW Plastics, Bethel, VT, a top contract manufacturer specializing in complex injection molded thermoplastic and silicone solutions, announced the graduation of its first summer internship class: five students all pursuing degrees in mechanical or electromechanical engineering.
The T (Trillion) Sensors Summit Munich 2014, the first in Europe, to be held September 15-17, has announced its final agenda, which will feature more than 40 presentations. Additional Summits are scheduled in San Diego (November 12-13, 2014) and Tokyo (December 8-9, 2014) with plans for 2015 Summits in Abu Dhabi, China, and US. For more information, visit www.Tsensorssummit-munich.org/ .
SME’s Advanced Manufacturing Expo (AMExpo) will be held at the Toronto International Centre, Toronto, Canada, from September 23-24. AMExpo, which features RAPID Canada Conference & Exposition and Medical Manufacturing Innovations, will showcase revolutionary 3D printing, additive and medical manufacturing technologies and applications, some being introduced in Canada for the first time. For more information, and to register, visit amexpo.ca or call 1-888-322-7333.
Keysight Technologies is hosting a seminar on “The Latest Developments in Semiconductor Device Characterization and SPICE Modeling for Advanced Silicon and III-V Technologies”, to be held September 30 in Albany, NY. For more information, visit http://keysightevents.distributech.ca/registration.asp?seminarid=582 .
SOLIDWORKS is sponsoring a one-day training event in NJ, Concept2Design, on October 2, featuring 16 training sessions. Events will be held throughout October in other venues. Or more information, visit http://www.caddedge.com/register-to-attend-a-solidworks-2015-launch-event?utm_campaign=EMAIL-SW%202015-Whats%20NEW&utm_source=email