Here is the latest batch of news from the medical products community. Please click the link for more.
Regulatory Approval
GE Healthcare, Salt Lake City, UT, announced FDA 510(k) clearance of its latest Brivo Plus C-arm, now available in the US. With legacy OEC image quality and ease-of-use, the new Brivo C-arm will offer a high quality, affordable option for basic surgical imaging.
Medtronic, Inc., Minneapolis, MN, announced that its Pacific Plus percutaneous transluminal angioplasty catheter has received both FDA clearance and the CE Mark and is launching the new peripheral balloon catheter in the US and internationally.
ArtVentive Medical Group, Inc., Carldsbad, CA, has received its CE Mark certification for the ArtVentive EOS™ Peripheral Vascular Endoluminal Occlusion system.
Integrity Applications, Inc., Ashkelon, Israel, has received CE Mark approval for its GlucoTrack® DF-F non-invasive blood glucose measurement device.
St. Jude Medical, Inc., St. Paul, MN, a global medical device company, announced FDA approval of its next-generation Ellipse™ and SJM Assura™ portfolio of implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators, designed to lower the risk of lead abrasion and to ensure high-voltage therapy delivery.
Blue Belt Technologies, Inc., Pittsburgh, PA, specializing in robotic-assisted solutions for orthopedic surgery, announced that it has received 510(k) clearance from the FDA to market its STRIDE™ Unicondylar Knee implant system.
Providence Medical Technology, Inc., San Francisco, CA, has received 510(k) clearance from the FDA for its PMT Cervical Cage, a novel minimally invasive implant and delivery system for cervical fusion procedures.
CAS Medical Systems, Inc., Branford, CT, a leader in medical devices for non-invasive patient monitoring, has received FDA 510(k) clearance for its next-generation 740 SELECTTM vital signs monitor and its MAX IQ™ non-invasive blood pressure technology.
Flambeau, Phoenix, AZ, a member of Nordic Group of Companies, Ltd., successfully secured ISO13485:2008 expanded scope certification for Class 7 and Class 8 clean room manufacturing, assembling, and packaging of medical device components.
Cook Medical, Bloomington, IN, has received FDA 510(k) clearance for the Evolution® Biliary Controlled-Release Uncovered Stent for the gastrointestinal tract, which allows the stent to be deployed or recaptured as needed.
EBS Technologies GmbH, Berlin, Germany, an emerging medical device company, has received CE Mark approval for its NEXT WAVE™ brain stimulation platform to treat neurological disorders caused by stroke and brain injury and expects to begin commercialization in Europe immediately.
CryoLife, Inc., Kennesaw, GA, a leading tissue processing and medical device company focused on cardiac and vascular surgery, announced achievement of a CE Mark for its HeRO (Hemodialysis Reliable Outflow) Graft system, a graft-based solution for end-stage renal disease patients, produced at the company's new manufacturing facility in Atlanta.
Teleflex Incorporated
Codman Neuro, part of the DePuy Synthes Companies of Johnson & Johnson, Warsaw, IN, has obtained the CE Mark for its REVIVE SE, a next-generation self-expanding clot removal device made of nitinol for use in treating acute ischemic stroke.
Leadership News
Freedom Innovations, Irvine, CA, a manufacturer of advanced technology prosthetic devices, has named Claudia Gehrmann as its General Manager for Europe.
Precision Engineered Products LLC, Attleboro, MA, has appointed Don Williams to the position of Vice President and General Manager of its Wauconda business unit, which specializes in intricate metal stampings for critical applications in the medical market.
LabStyle Innovations Corp., Ramat Gan, Israel, an emerging leader in the mobile health sector and developer of the Dario™ smartphone-based diabetes management system, has appointed medical device and internet sales veteran Mikael Salo as Managing Director of Sales for Scandinavia.
Ximedica, Providence, RI, a provider of product development services to medical device makers, announced the addition of three new members to its Human Factors Team. Paul Cassidy joins as Principal Human Factors Scientist and Rebecca Huebner joins as a Human Factors Engineer, both in the company’s Minneapolis office. Tatyana Budantsev joins as a Human Factors Engineer in the Providence office.
Resonetics, Nashua, NH, a leading supplier of laser micromachining solutions for polymers and glass, announced the expansion of its account management team serving the life sciences industry. In response to growing global demand for highly-precise medical devices and diagnostics, the company has trained technical representatives to serve local clients in the European Union, Japan, China, and Israel. The company has also added two more resources in the United States to focus on the Central and Northeast medical device and diagnostic clusters.
Innomech, Cambridge, UK, has appointed Dr. Peter Woods, an expert in pharmaceutical automation and currently program manager, to take charge of developing automated manufacturing systems for the assembly and test of medical devices, such as drug delivery pens, contact lenses, diagnostic kits and surgical instrumentation.
Expansions/Moves
Riverdale Global, Perth Amboy, NJ, a new company formed to provide plastics processors in the US and overseas with highly localized service for liquid colors, promises to completely eliminate the handling problems associated with liquids, supplying high-quality, consistent colors regardless of location and providing full access to the cost advantages of liquids over pellet concentrate or masterbatch The company is establishing a network of satellite operations in the U.S. and abroad to make readily available its technologies for producing, delivering, metering, and replenishing liquid colors.
Syneo, West Palm Beach, FL, a leader in automation for medical device manufacturing, has moved to a larger 20,000 sq. ft. location, which includes a laser development lab, a product demonstration room, and 10,000 sq. ft. of assembly area.
ECA Medical Instruments, Thousand Oaks, CA, a leading designer and manufacturer of single-procedure torque-limiting and fixed-driver surgical instruments and procedural kits, has moved into a new 24,000 sq. ft. corporate headquarters, which includes a design center of excellence and product development laboratory.
The University of Minnesota opened an 8,000-square-foot state-of-the-art Medical Devices Center in Minneapolis. The $2.3 million facility features a 3D virtual design lab, a fully equipped X-ray and imaging lab, an anatomy lab and a mechanical lab complete with drills, punch press, jigsaw and will have a 3-D printer from Stratasys Ltd.
Seco Tools, a leading provider of metalcutting solutions, is relocating its US distribution center from Troy, MI, to Hebron, KY, a move that it says will streamline shipping operations and better serve customers.
Merit Medical's new hypotube Center of Excellence, located in Galway, Ireland, includes best-in-class technologies for producing customized hypotubes for PTCA and PTA balloon catheters and functional guide wires.
Blackrock Microsystems, Salt Lake City, UT, announced the grand opening of its new 60,000-square-foot headquarters in the heart of the University of Utah’s Research Park, created to accelerate Blackrock’s world-class innovation in creating advanced technology tools and systems. The new facility features a built-in, leading-edge clean room facility to service the fabrication needs of the company’s clean-tech implantable systems.
Mergers/Acquisitions/Collaborations
TranS1 Inc., Raleigh, NC, a medical device company focused on designing, developing, and marketing products to treat degenerative conditions of the spine affecting the lumbar region, has completed its acquisition of Baxano, Inc. a privately-held medical device company that manufactures a system utilized in standard spinal decompression surgery.
Kollmorgen, Radford, VA, has acquired MCS Engenharia Ltda., a leading Brazilian-based manufacturer and system integrator of standard and customized high performance motion controllers and complementary motion control components. Established in 1983 and headquartered in Tamboré, São Paulo, Brazil, MCS is Brazil’s largest domestic supplier of precision motion controllers.
Teleflex Incorporated, Limerick, PA, a leading global provider of medical devices for critical care and surgery, has acquired Eon Surgical, Ltd., Tel Aviv, Israel, a late stage development company providing a minimally invasive microlaparoscopy surgical platform technology.
RTI Biologics, Inc., Alachua, FL, a leading provider of orthopedic and biologic implants, announced its agreement to acquire privately held Pioneer Surgical Technology , Marquette, MI, a leading company that manufactures and distributes metal and synthetic products in the orthopedics, biologics, spine, trauma, and cardiothoracic markets.
Leonhardt Ventures, Santa Monica, CA, has partnered with CORE Manufacturing, LLC, Valencia, CA, to manufacture and bring to market a lineup of breakthrough medical technologies, including a heart pacemaker designed to recruit stem cells to damaged or weakened heart tissue, an implantable pump designed to deliver controlled dosages of stem cells and growth factors, a non-invasive device that focuses electrical energy onto aortic vessel walls to convert stem cells into smooth muscle, and a vibrational-energy-emitting pacemaker add-on to prevent arterial plaque formation.
Miscellaneous
ATW Companies Inc., Warwick, RI, a leading provider of custom manufactured metal components and services, announced that Parmatech Corporation , Petaluma, CA, its custom manufactured metal injection molded components and services subsidiary, is celebrating its 40th anniversary in business. Parmatech , focuses on metal injection molding and secondary operations for the medical, telecommunications, firearms, hand tools, semiconductor, and electronic packaging markets.
