Yoqneam, Israel - Given Imaging Ltd. officials announced that the U.S. Food and Drug Administration (FDA) has cleared PillCam COLON as a new modality to provide visualization of the colon. It may be used for detection of colon polyps in patients after an incomplete optical colonoscopy with adequate preparation and a complete evaluation of the colon was not technically possible. PillCam COLON received clearance under the direct de novo classification for devices with low to moderate risk that have no predicate on the market.

Watch a video about how the PillCam works by clicking here.

As previously announced, Given Imaging conducted an 884-patient, 16-site clinical trial studying the accuracy and safety of PillCam COLON 2 compared to optical colonoscopy in detecting adenomas 6mm or larger. Results from this clinical trial demonstrated that the sensitivity for PillCam COLON was 88% and specificity was 82% in detecting adenomas at least 6 millimeters in size.¹ The FDA based its clearance decision on an analysis of this clinical trial data that used a more restrictive methodology for matching polyps. In this analysis, which was conducted on hyperplastic polyps and adenomas, the positive percent agreement for PillCam COLON and optical colonoscopy was 69% and negative percent agreement was 81% for polyps at least 6mm in size.²

"PillCam COLON will improve patient care by offering a new and effective colon imaging option for patients who have experienced an incomplete colonoscopy. Among the limited alternatives available after incomplete colonoscopy, PillCam COLON gives us a minimally invasive, radiation-free option that provides endoscopic images of the same basic type that have made colonoscopy so useful," said Douglas Rex, M.D., distinguished professor of medicine and chancellor's professor, Indiana University School of Medicine and Director of Endoscopy, Indiana University Hospital.

Incomplete colonoscopies occur in approximately 750,000 patients in the United States per year.^3,4 Patients with incomplete colonoscopies often incur additional costs along with the inconvenience and risk of other procedures to complete the colorectal examination. The incidence of incomplete colonoscopies is higher in women due to the increase in past pelvic surgeries and the differing anatomy of women that includes particularly acute rectosigmoid angles in thin women. Patients with a redundant or long colon, history of abdominal surgery or advanced diverticular disease are also at a higher risk for experiencing an incomplete colonoscopy.

"We have made tremendous strides in increasing the number of people who are getting screened for colon cancer, starting at age 50 for the average risk individual. Colonoscopy is the most comprehensive option, but for up to 10% of individuals, achieving a complete colonoscopy may not be possible. For those individuals, PillCam COLON capsule endoscopy could be an effective option to allow their gastroenterologist to complete a colon examination. And who wouldn't want that kind of peace of mind for this unique cancer – that we can largely prevent with the aid of diagnostic exams that detect the presence of polyps," said Eric Hargis, CEO, Colon Cancer Alliance.

"The clearance of PillCam COLON by the FDA represents a pivotal moment in the evolution of Given Imaging as a GI medical device leader. This important event caps a string of significant regulatory milestones for our company including clearance of PillCam COLON in Japan and PillCam SB 3 in both the U.S as well as Japan. We look forward to working closely with the U.S. gastroenterology community to bring this clinically-proven, diagnostic tool to patients who need to have a thorough colorectal exam following an incomplete colonoscopy," said Homi Shamir, President and CEO, Given Imaging. "While we believe that PillCam COLON will ultimately play an important role in both the global colorectal cancer diagnostic and screening market, this initial indication is an important first step. To this end, we are making good progress in advancing additional clinical studies that should support the expanded indications."

To date, PillCam COLON clinical data have been validated in 34 publications. PillCam COLON is commercially available in more than eighty markets including Japan, Europe, Latin America, Canada, Australia and parts of Asia and Africa. 

About PillCam COLON
The PillCam COLON video capsule is equipped with two miniature color video cameras (one on each end), a battery and an LED light source; it measures 12mm X 33mm. PillCam COLON is designed to be ingested by the patient and transmits 4 or 35 frames per second for approximately 10 hours to a recording device worn by the patient. Data are transferred from the device to a computer that uses RAPID software to compile the video data and enable the physician to review and report the results of the PillCam study.

The risks of PillCam capsule endoscopy include capsule retention, aspiration and skin irritation. The risks associated with colon preparation are allergies or other known contraindication to any preparation agents or medications used for the PillCam COLON regimen, according to laxative medication labeling and per physician discretion. After ingesting the PillCam capsule and until it is excreted, patients should not be near any source of powerful electromagnetic fields, such as one created by an MRI device. Medical, endoscopic or surgical intervention may be necessary to address these complications, should they occur. A normal or negative capsule endoscopy examination does not exclude the possibility of colon polyps or colon cancer.

Source: Given Imaging

^{1 Rex DK et al. Accuracy of PillCam Colon 2 for detecting subjects with adenomas ≥ 6mm. Abstract presented at Digestive Disease Week; 2013 May 18-21; Orlando, Fla.}

^{2 Data on file with Given Imaging}

^{3 Rex DK, Petrinin JL, Baron TH, et al. Quality Indicators for Colonoscopy. Am J Gastroenterol 2006;101:873-85.}

^{4 Seeff LC, Richards TB, Shapiro JA, et al. How many endoscopies are performed for colorectal cancer screening? Results from CDC's survey of endoscopic capacity. Gastroenterology 2004;127:1670–1677.} 

San Francisco & Washington – Autodesk Inc. is joining President Barack Obama and other leading technology and telecom companies to help prepare American high school students for science, technology, engineering, art, and mathematics (STEAM) careers. The company will expand its Design the Future program, and make available $250 million of 3D design software, project-based curricula, training, and certification to every middle and high school in the United States in 2014.

“Our customers have unfilled, high-paying positions due to the lack of qualified U.S. high school and university graduates,” said Carl Bass, Autodesk president and CEO. “As part of our ongoing commitment to training and equipping the next generation of designers, engineers, architects and digital artists, we are proud to respond to the call from President Obama. Today we are committing to making our Design the Future program available to every secondary school in the United States over the next year.”

The Design the Future program provides secondary school teachers everything they need to teach students critical problem-solving skills and to prepare them for careers in STEAM fields such as engineering and architecture. First launched as a pilot in California in 2013 and expanded to Texas in 2014, the program empowers educators to help students develop a lifelong love for STEAM subjects by providing free access to current versions of Autodesk 3D design software (including more than 14 key products for architecture, engineering and entertainment), project-based curricula assigned to Common Core, and ISTE standards, training, and certification. In the first six months of the program, more than 350 California schools have enrolled. With today’s commitment, Autodesk will make its software available for free to educators at more than 27,000 U.S. secondary schools. If all schools take advantage of the offer, the total value of Autodesk’s offering will exceed $250 million. For more information on Design the Future, visit http://www.autodesk.com/campaigns/design-the-future-us/home. For more information on Autodesk’s free offerings for students and educators, visit http://students.autodesk.com.

Source: Autodesk Inc.

North Charleston, SC – The Coordinate Metrology Society (CMS) announced registration is open for the 2014 Coordinate Metrology Systems Conference (CMSC) to be held at the Embassy Suites, North Charleston, S.C. from July 21-25, 2014. The organization will commemorate the 30th anniversary of its conference held annually to highlight state-of-the-art technologies in the portable 3D metrology industry. At CMSC 2014, expert and novice metrology professionals will convene to learn about the successful implementation and usage of measurement/inspection solutions as applied by manufacturers and science laboratories. Online attendee registration is now open at https://www.cmsc.org/register. Interested exhibitors will find registration details at https://www.cmsc.org/cmsc-exhibitor-information. 

The CMSC is well known for its expansive slate of technical papers and presentations covering successful applications, best practices, and research and development in the field of metrology. For three decades, the conference has attracted metrologists, manufacturing executives, quality managers, scientists, students, educators and other industry professionals looking to broaden their skill sets and knowledge of portable 3D measurement instrumentation and software.

At CMSC 2014, the Coordinate Metrology Society will also conduct examinations for CMS Level-One and Level-Two Certification for 3D Portable Metrology. The proctored tests measure and verify the technical competence of career bound metrology professionals. For more information about the program and certification guidelines, visit http://www.cmsc.org/cms-certification.

In addition to high-level technical paper presentations, conference attendees will find a balanced blend of metrology solutions and services, industry updates, user group meetings, and educational workshops. CMSC also provides networking opportunities to meet Coordinate Metrology Society members and industry thought leaders. The five-day agenda includes the 5th Annual CMS Measurement Study, the annual Wednesday evening banquet, and an optional Friday sightseeing tour. CMSC’s Exhibitor Hall will showcase more than 40 service providers and vendors of portable measurement technology including industrial photogrammetry solutions, laser trackers, laser radars, articulating arms, GPS systems, laser scanners, laser projection systems, theodolites, and more. 

Call for papers continues through March 14, 2014
The Coordinate Metrology Society continues its Call for Papers for the 2014 CMSC until March 14, 2014. Abstract submissions are peer-reviewed by the Coordinate Metrology Society and considered for presentation at CMSC 2014. Notification of acceptance will occur on April 4, 2014. For guidelines or more information about presenting a technical paper at CMSC 2014, contact Scott Sandwith, technical presentations coordinator at presentations@cmsc.org. Guidelines for presentations and technical papers can be downloaded at 2014 CMSC Guidelines. Conference speakers gain recognition as industry experts, and all accepted white papers are peer reviewed and considered for publication in the Journal of the CMSC.  

Source: CMS

Sudbury, Massachusetts – Methods Machine Tools Inc. officials announced the addition of a new dealer, Maruka USA. Maruka will represent the Nakamura, Fanuc RoboDrill, KIWA, FEELER and YASDA lines in Kansas, Missouri, Arkansas, Oklahoma, Florida, New Jersey, Pennsylvania, Long Island, Metro New York area, and the New York counties of Orange, Sullivan, Ulster, Greene, and Columbia. Maruka’s strong presence in the Midwest and Mid-Atlantic regions, as well as in Florida, compliments Methods’ coverage in these markets. 

“The addition of Maruka USA to our distributor network strengthens our capabilities and support in these key areas of the U.S.,” said Dave Lucius, vice president of sales for Methods Machine Tools, Inc. By joining forces, Maruka and Methods offer over 100 years of combined experience in the manufacturing industry. Lucius continued, “Together we provide even stronger applications expertise, machines, and technology to our customers.” 

Maruka USA, founded in 1968, has offices in Lee’s Summit, Mo., Wichita, Kan., Broken Arrow, Okla., Largo, Fla., and Pine Brook, N.J. It serves the manufacturing industry providing metalworking, plastics processing and fabrication equipment plus local service and support on all types of equipment. Maruka is committed to offering clients the most comprehensive sales and service available. To contact Maruka USA go to www.marukausa.com.