Here is the latest batch of news from the medical products community. Please click the link for more.

Regulatory Approval

St. Jude Medical, Inc., St. Paul, MN, a global medical device company, announced FDA approval and first use of its MediGuide Enabled Ablation Catheters, which are used to treat specific irregular heartbeats.

With the first US implants of its new RestoreSensor® SureScan® MRI neurostimulation systems, Medtronic, Inc., Minneapolis, MN, is introducing the first and only implantable neurostimulation systems to treat chronic, intractable back and/or limb pain that are approved by the FDA for conditionally safe full-body Magnetic Resonance Imaging under specific conditions.

LDR, Austin, TX, offering exclusive spinal implant technologies for both non-fusion and fusion applications, has received a letter of approval from the FDA allowing the commercial sale and distribution of the Mobi-C Cervical Disc for two-level indications, making it the first and only cervical disc in the US approved to treat more than one level of the cervical spine.

Given Imaging Ltd., Duluth, GA, has been granted FDA 510(k) clearance for its next-generation Pillcam SB3, a swallowable camera designed to detect and monitor small bowel abnormalities associated with Crohn’s disease, obscure gastrointestinal bleeding and iron deficiency anemia.

NxThera, Inc., Maple Grove, MN, a privately held medical device company focused on the development of its proprietary and innovative water vapor endourology treatment platform, has received the CE Mark for its Rezūm® System to treat benign prostatic hyperplasia.

Ortho Kinematics‚ Inc., Austin, TX, a healthcare diagnostic company focused on spine imaging informatics, announced receiving FDA 510(k) to expand its Vertebral Motion Analysis system beyond the lumbar spine, so the system can be available for cervical spine assessments, too.

CoAlign Innovations, Inc., Redwood City, CA, announced that its AccuLIF® XL lateral expandable interbody fusion devices have received marketing clearance from the FDA. This new product line addresses fusion procedures employing the lateral approach

Standex-Meder Electronics, Cincinnati, OH, a manufacturer of precise, reliable, and long-lasting miniature switches, sensors and relays, announces that its MK02, MK11, MK21P, MK26, and MK27 series of reed sensors are now rated IP67. These five lines have achieved this demanding accreditation, which certifies that the sensors are both totally protected against dust and protected against the effects of immersion between 15cm and 1m.

Kelpac Medical, a global manufacturer of medical device tubing and packaging, announced certification of its quality management system to ISO 9001:2008 for its Pleasant Prairie, Wisconsin and Johor, Malaysia plants. Kelpac Medical manufactures extruded blown film packaging products in its Wisconsin facility and tubing extrusion in Malaysia for the medical device industry.

Sanford Process Corporation, Woonsocket, RI, a subsidiary of Katahdin Industries, Inc., announces that MICRALOX® micro-crystalline anodic coating has been granted the first patent (Patent No. 8512872) by the USPTO. MICRALOX® micro-crystalline aluminum anodic coating is designed specifically for applications where conventional anodizing and hard coat anodizing fail to protect the finish from corrosion, chemical attack, and steam discoloration.

AngioDynamics, Latham, NY, announced that Navilyst Medical Inc., an AngioDynamics company, was granted FDA 510(k) clearance for its BioFlo Port with Endexo technology designed to reduce the accumulation of catheter-related thrombus on, and in, port catheters.

Reverse Medical Corporation, Irvine, CA, announced FDA clearance for US commercialization of its MVP™ Micro Vascular Plug system for peripheral artery embolization, and the first US clinical cases.

Leadership News

Medigus Ltd., Omer, Israel, an endoscopy technology company, has appointed Christopher Rowland as its new CEO. He has 24 years of experience in the medical device market.

Nicky James, a 15-year veteran of Cook Medical, Bloomington, IN, has been named Vice President and global leader of Cook’s Aortic Intervention (AI) clinical division. Phil Nowell, who has held that position for five years, will return to his native Australia and take on a new role with the company to further enable Cook’s rapid growth in the Asia-Pacific region.

Noxilizer, Inc., which is advancing room temperature NO2-based sterilization technology for life science manufacturers, announced the appointment of Michael Valentine as Vice President of North American Sales.

Sandvik Coromant, Fair Lawn, NJ, has appointed Björn Roodzant as Vice President Marketing and Communication. He takes over from Jessica Alm, who recently became Executive Vice President and Head of Group Communications at the Sandvik Group.

Precision Polymer Engineering (PPE), Blackburn, UK, one of the world’s leading manufacturers of high performance molded elastomer seals, has appointed Lawrence Aldridge as operational excellence manager. He will work in both PPE and its sister company FTL Technology (FTL) based in Leeds, UK.

Advanced Circulatory, Roseville, MN, makers of multiple medical devices and the pioneer of Perfusion on DemandTM therapy, has added Roger W. Heegaard to its Board of Directors.

Servometer, Cedar Grove, NJ, a manufacturer of metal bellows, custom electroforms, flexible couplings, and contacts, announced that Fred G. Poelzing has recently joined the company as the Technical Sales Manager.

Aptiv Solutions, Reston, VA, a global biopharmaceutical and medical device development services company and leader in adaptive clinical trials, announced the appointment of Patricia Monteforte as President of Trio Clinical Resourcing, an Aptiv Solutions subsidiary devoted to clinical and regulatory staffing. The company also announced that Vlad Dragalin, PhD, Senior Vice President of Software Development and Consulting, was elected as a Fellow of the American Statistical Association.

The Medical Device Innovation Consortium, a public-private partnership between the FDA and the medical device industry committed to improving patient health and the overall efficiency of the medical device industry through the application of regulatory science, announced William V. Murray has been selected to serve as president and CEO. He succeeds interim Executive Director Dale Wahlstrom, who will return to his full time role as the president and CEO of LifeScience Alley (LSA) and the BioBusiness Alliance of MN (BBAM).

Expansions/Moves

Berkeley Research Group LLC, Emeryville, CA, a leading global expert services and consulting firm, has established a new office in Philadelphia. BRG Director Edward Buthusiem, who leads the firm's Corporate Compliance and Risk Management Advisory services, will head the new office.

Covidien, Dublin, Ireland and Mansfield, MA, a leading global provider of healthcare products, announced the opening of the Covidien Center of Innovation Korea (CCI Korea), its first research & development, training, and education center in Seoul, Korea.

Mergers/Acquisitions/Collaborations

iTraumaCare, San Antonio, TX, an early-stage medical device firm focused on developing traumatic injury solutions for first responder and military medicine applications, has selected Combat Medical Systems as its US Military distributor.

Carestream Health, Orchard Park, NY, and the Buffalo Bills football team have entered into an agreement that will aid Carestream’s development of advanced medical imaging technology designed to help with earlier detection and monitoring of brain injuries. This partnership focuses on the need for new technology to help address key concerns in sports medicine.

St. Jude Medical, Inc., St. Paul, MN, has agreed to buy Switzerland-based medical technology company Endosense SA, which focuses on catheter ablation to treat cardiac arrhythmias.

AtriCure, Inc., West Chester, OH, and Century Medical, Inc. (CMI) of Japan announce the extension and expansion of their multi-year agreement in which CMI will distribute AtriCure’s surgical ablation technologies to hospitals in Japan.

Miscellaneous

Mazak Corporation, Florence, KY, a leader in the design and manufacture of productivity-improving machine tool solutions, recently named Kurt Manufacturing Company, Industrial Products Division, Minneapolis, MN, a leading provider of workholding solutions, to its exclusive Value Inspired Partner (VIP) technology program that brings total manufacturing solutions to Mazak customers. As a certified VIP, Kurt will collaborate with Mazak on R&D and integration efforts to create more innovative products and turnkey processes for the US manufacturing market.

S and Y Industries, Inc., Winfield, KS, a provider of electronic manufacturing services, has been named to the Inc. 5000 list, published by Inc. magazine, as one of the fastest-growing, private companies in America. This recognition marks five straight years of being on this prestigious list.

Cable engineering company, Northwire, Inc., Osceola, WI, has been honored for the second year in a row on the Inc. 5000 list of fastest-growing private companies in America. As a cable manufacturer, Northwire celebrates more than 41 years of innovation in the design, manufacture and contract services of custom technical products.

Strategies in Biophotonics Conference & Expo, is scheduled for September 9-11, 2014, in Boston, MA at the Boston Park Plaza Hotel. This event will center on advancing the development and successful commercialization of optics and photonics technologies for the life sciences. For more information and to register, visit http://www.strategiesinbiophotonics.com .

Advanced machine tool builder GF AgieCharmilles, Lincolnshire, IL, debuted a new US website featuring an improved user experience that allows manufacturers to quickly access the company’s products, technologies, and applications. The new website is located at www.gfac.com/us .

Henkel Corporation, Rocky Hill, CT, has fully updated their 40 Loctite® Equipment Showrooms to provide an easy, hands-on educational experience. In September, October, and November, each Loctite Equipment Showroom location will hold an open house to introduce new and existing customers to the latest Loctite equipment and adhesive innovations. To find out more, visit www.equipment.loctite.com/equipmentshowrooms .