Here is the latest batch of news from the medical products community. Please click the link for more.
Regulatory Approvals
MAQUET Cardiovascular LLC, Wayne, NJ, a leading provider of cardiovascular technologies, has received 510(k) clearance from the FDA and European CE mark approval for its new AIR-BAND™ Radial Compression Device. Indicated to assist hemostasis of the radial artery after a transradial procedure, the device is designed to compress the radial artery puncture site while maintaining site visibility and a secure fit around the wrist.
Elekta AB, Stockholm, Sweden, recently received 510(k) clearance from the FDA, allowing the company to begin shipping and installing all components of the Versa HD™ system within the United States. The system features high precision beam shaping and tumor targeting, and is capable of delivering radiation doses three times faster than previous Elekta linear accelerators.
CAS Medical Systems, Inc., Branford, CT, a leader in medical devices for non-invasive patient monitoring, today reported receipt of U.S. Food and Drug Administration (FDA) 510(k) clearance for its next-generation FORE-SIGHT ELITE™ Absolute Tissue Oximeter, developed to provide absolute cerebral oxygenation levels in adult and transitional adolescent patients weighing 40 kilograms or more.
Microline Surgical, Inc., Beverly, MA, a leading manufacturer of reposable instruments for minimally invasive surgery, has received 510(k) clearance from the FDA for its Flexible Ligating Shears, enabling surgeons to effectively cut and seal soft tissue.
Aspect Imaging, Toronto, Ontario, Canada, a leading developer of compact high-performance magnets, announced that the FDA has cleared the company's M2 compact MRI system for diagnostic imaging of the wrist. The system is a novel compact, high-performance MRI instrument for rapid, just-in-place imaging of the wrist.
MedShape, Inc., Atlanta, GA, an industry leader in innovative shape memory orthopedic devices, announced that the company has received FDA 510(k) clearance for its Eclipse™ Soft Tissue Anchor, a new shape memory fixation device designed to attach a tendon, ligament, or soft tissue to bone.
Life Care Medical Devices Ltd., New York, NY, has received the CE mark for its Keyhole Cup Laparoscopic Access Device, which is used to separate the abdominal wall from underlying organs before inflating the abdomen in laparoscopic surgery.
Express Logic, Inc., a worldwide leader in royalty-free, real-time operating systems (RTOS), announced that its popular ThreadX® RTOS, deployed in over 1.5 billion electronic products worldwide, has been certified by SGS-TÜV Saar for use in safety-critical systems. The certification confirms that ThreadX can be used in the development of safety-related software for the highest safety integrity levels of the International Electrotechnical Commission (IEC) 61508 and IEC 62304, for the “Functional Safety of electrical, electronic, and programmable electronic safety-related systems.”
Leadership News
InspireMD, Inc., Tel Aviv, Israel, announced that Gwen K. Bame has joined the company as Vice President of Corporate Development. InspireMD is a medical device company focusing on the development and commercialization of its proprietary stent system technology, MGuard™.
OHK Medical Devices Ltd., Haifa, Israel, manufacturer of the HemaClear single-use, sterile exsanguinating tourniquet device, has appointed Omer Inbar as Chief Executive Officer.
OMAX Corporation, Kent, WA, a leader in abrasive jet machining, has named Lorant Keseru as regional sales manager for Southeast Europe and the Middle East.
NSF Becker & Associates Consulting, Inc., has launched a new program to assist companies in achieving 360 operational compliance to the commercial practices of the life science industry. Industry veteran Francisco (Frank) T. Rivas, who has more than 25 years’ experience in all aspects of the pharmaceutical, diagnostics, and medical device industry, has been appointed to lead the NSF Becker Corporate Compliance Practice Group.
Crane Co., Stamford, CT, a diversified manufacturer of highly engineered industrial products, today announced that Eric C. Fast, Chief Executive Officer, will retire from Crane in January 2014. He will be succeeded by Max H. Mitchell, currently President and Chief Operating Officer, who was appointed president of the company in January 2013.
MC Machinery Systems Inc., Wood Dale, IL, announced that Justin Kellerson has been appointed as Sales Manager for Mitsubishi waterjet and milling in the state of Connecticut.
Pro-Dex, Inc., Irvine, CA, announced the appointment of Richard Van Kirk to the position of Chief Operating Officer. In addition to his new responsibilities overseeing all non-administrative operations of the Company, he will retain direct responsibility for the company's manufacturing functions.
Haselmeier, Zurich, Switzerland, a designer and manufacturer of pen and auto-injection systems, has established a new company in the United States, Haselmeier, Inc., that will be headed by Robert J. Kilgore. The new location will be in Severna Park, MD.
Moore Industries-International, Inc., North Hills, CA, which designs and manufactures electronic measurement and interface instruments for various process industries, has hired Tom Watson as its new Corporate Marketing Manager.
Expansions/Moves
Fixes 4 Kids, Inc., Salt Lake City, UT, has relocated its manufacturing operations to North Dakota. Working with Wahpeton-based ComDel Innovation, the company is focused on developing a range of products to address complex pediatric orthopedic fractures.
MIDI, Ronkonkoma, NY, a global leader in medical product development, announced today the formation of a Medical Center of Excellence, centrally located on Long Island, within Smithtown’s Village of the Branch. The 15,100 square foot facility will significantly assist in facilitating MIDI’s rapid growth and presence in the medical/healthcare product development industry.
Flextronics, Singapore and San Jose, CA, announced the opening of its new medical design center located in Milan, Italy. This Design and Industrialization Center, which provides services to customers in the medical industry, is ISO 13485 certified and provides world-class expertise for FDA class II and III medical devices, drug delivery devices, medical equipment, and disposables.
East West Manufacturing, Atlanta, GA, a global contract manufacturer, announced the addition of two divisions that will expand its Vietnam operations. East West’s Vietnam facility’s ISO 9001:2008 and ISO13485:2003 certifications support the new Medical Device Contract Manufacturing and Electronic Manufacturing Services divisions that will be located in the Binh Duong province of Vietnam.
Mergers/Acquisitions/Collaborations
Curie-Cancer, Paris, France, the body responsible for developing Institut Curie’s industry partnership activities and Vygon, Ecouen, France, a French family-run business that develops, produces, and markets medical devices, including catheters and implantable ports for administering chemotherapy treatments, have partnered to develop a new generation of innovative medical devices, mainly for use in chemotherapy. The partnership aims to introduce them to European, the US and Asian markets.
Plasmatreat US, Elgin,IL, has acquired the low-pressure plasma company 4th State, Inc., Belmont, CA. The Plasmatreat Group (headquartered in Germany) is the international market leader in atmospheric plasma-jet technology. 4th State, Inc. is a specialist for plasma modification of rolled goods including plastic films, foils, membranes, wovens and non-wovens, for the medical, aerospace, and electronic industries.
Smiths Medical, Dublin, OH, a global medical device manufacturer, announced an agreement with Epic, Verona, WI, to develop connectivity between the company’s infusion systems and Epic’s Electronic Medical Records system that will allow for the transfer of infusion data to the Epic electronic medical record system.
ZOLL Medical Corporation ruggedized version of the Mobile CareGuide™ sensor for detecting the onset of shock in patients during air and ground military, and EMS patient transports, as well as hospitalizations.
Abyrx, Inc., Irvington, NY, has acquired substantially all of the assets of Orthocon and DRG. The company's portfolio of products includes three FDA-cleared putties that stop bone bleeding and two applicator devices. Its advanced technology platforms are being developed to create products that support bone healing, enable re-approximation of bone surfaces, and deliver drugs to bone.
Miscellaneous
PRISYM ID, Wokingham, UK, was awarded the Queen’s Award for Enterprise in Innovation 2013, the highest official UK award for British businesses. PRISYM ID was selected for its innovative web-based labeling solutions for the medical device market, enabling increased efficiency, consistent branding, and robust compliance with regulations regarding electronic records and signatures for global manufacturers leading to improved patient safety.
Integra Technologies LLC, Wichita, KS, is celebrating its 30th year as a leading supplier of integrated circuit test and evaluation services in the US and Europe. Begun in 1983 as part of NCR Corporation with a small test floor, today, Integra's test facility in Wichita has more than 41,000 square feet of state-of-the-art test equipment and engineering development offices.
Boothroyd Dewhurst, Inc., Wakefield, RI, will host the twenty-eighth annual International Forum on Design for Manufacture and Assembly (DFMA) on June 12-14, 2013. This year’s Forum, “Engineering Value with DFMA—Unlocking Profits in Product Design,” will take place at the Crowne Plaza Hotel, Providence-Warwick, RI.
Nordson EFD won the Design News Golden Mousetrap Award for its Square Wave™ 745NC high speed, non-contact dispense valve for the photovoltaic industry, presented at the Pacific Design & Manufacturing Show in Anaheim, CA. The company also won Circuits Assembly's Service Excellence Award for customer service excellence, presented at IPC APEX 2013, held in San Diego, CA.
Norman Noble, Inc., Highland Heights, OH, a leading contract manufacturer of medical devices and implants, has launched a new virtual tour of its manufacturing facilities on its web site, www.nnoble.com .
Defibtech, Guilford, CT, which creates and manufactures automated external defibrillators, received the 2013 “Exporter of the Year” Award on Capitol Hill from ThinkGlobal Inc., publisher of Commercial News USA, the official export promotion magazine of the U.S. Department of Commerce.
Carl Zeiss Microscopy, Thornwood, NY, has donated a Stemi 2000C stereo microscope with an AxioCam ERc 5s camera, which can also work as a stand-alone imaging station, for an innovative biomedical summer research and college preparatory internship program for minority senior high school students at Children’s Hospital Los Angeles..
A recent study funded by Centers for Disease Control and Prevention (CDC) Epicenters Program and published in Infection Control and Hospital Epidemiology, supports and expands on previously published studies confirming the effectiveness of an automated UV-C-emitting device to combat pathogens in hospital settings. The TRU-D SmartUVC™, a portable UV disinfection system unique to the market with Sensor360™ technology, which analyzes the unique contents, shape and size of the room to calculate the precise pathogen-lethal dose of UV-C light needed to properly disinfect the environment was the device tested.
The Swedish company Inerventions and their product Elektrodress won the Robotdalen Innovation Award 2013. Elektrodress is based on electrical muscle stimulation therapy integrated into a wash and wear bodysuit that relaxes spastic muscles and thus improves function and mobility for people with spastic muscles, due to neurological disorders.
