Given Imaging pursues FDA nod for its capsule endoscopy system

Given Imaging submitted for FDA approval its PillCam Colon 2 capsules endoscopy system, a device designed for the visualization of the colon.

The Israel-based company hopes to get the FDA nod through the federal watchdog agency’s de novo approval pathway.

The PillCam Colon 2 capsule endoscopy system could help patients with high risk or incomplete optical colonoscopy minimize the potential adverse events and reduce the risks of CT colonography or double-contrast barium enema procedures, according to a press release.

"Filing for FDA clearance is another important milestone for Given Imaging in advancing our efforts to commercialize PillCam Colon 2," president & CEO Homi Shamir said in prepared remarks. "We believe that PillCam Colon 2 meets a significant unmet need for a non-invasive imaging tool for visualization of the lower GI tract for physicians and their patients who are unable to undergo colonoscopy or in cases of an incomplete colonoscopy."

About 147,000 people in the U.S. are diagnosed with colorectal cancer annually, according to the National Cancer Institute, but only 50% of population undergo colonoscopy in the U.S., according to the press release.

The PillCam Colon 2 system features 2 miniature color video cameras and could be ingested by the patient, transmitting up to 35 frames per second for approximately 10 hours inside the body, the company said.

Given Imaging in October spent $6 million to buy SmartPill’s GI monitoring device, an ingestible capsule that uses sensor technology to measure pH, pressure and temperature in the gastrointestinal tract.

RSS From Medical Design & Outsourcing

  • Albright Technologies expands their silicone offerings
    Albright Technologies, a rapid silicone prototyper, has added silicone injection molding tooling and services to its product lineup. Liquid silicone injection molding became a suitable product offering as Albright expanded its offerings to better serve the silicone molding market. While silicone prototypes are commonly manufactured with low volumes in mind; injection molded liquid silicone rubber parts are […]
  • Applied Silver launches SilvaClean, silver treatment for textiles
    Applied Silver, Inc, is launching SilvaClean, a state-of-the-art silver treatment for textiles, at the Association for Professionals in Infection Control and Epidemiology’s (APIC) forty-second Annual Conference taking place at the Music City Center in Nashville, from June 27 through June 29. Hospitals have invested significantly in reducing the potential of infection through products and processes designed […]
  • Two-Component technology for improved quality of life
    In the field of injection molding and mold making, toolcraft covers all processes within the added value chain–from the design and selection of materials through to the creation of finished and qualified products. Complete solutions offered include injection molding for parts in the small and extremely small component areas, e.g. for medical technology. Utilizing two-component […]
  • GDS security protects medical devices from hackers
    As data breaches become more commonplace with serious consequences to personal, corporate and national security, it is clear that there is no shortage of accomplished and effective hackers ready to steal data and trade it on the open market. Global Data Sentinel (GDS) has the ability to provide retroactive security to remove access to email […]
  • BRAEBON and SomnoMed combine products to combat sleep apnea
    BRAEBON Medical Corporation announces that the DentiTrac oral appliance compliance system has passed a regulatory hurdle and is now FDA cleared in the USA for use with the SomnoDent oral device. BRAEBON congratulates SomnoMed for being the first company to achieve this milestone. “We are pleased DentiTrac is launching in the US market. Accurate oral appliance […]
  • For advanced shielded plastic connector solution, ODU delivers with latest product
    ODU, a company which designs and manufactures connector solutions and cable assemblies, is announcing ODU MEDI-SNAP EMC, the advanced shielded plastic connector solutions, to the US market. ODU MEDI-SNAP EMC is the latest addition to ODU’s Push-Pull circular connectors. The advanced medical connector solution is lightweight, autoclavable, sterilizable and it offers a touch proofed housing and reliable […]
  • LifeVac steps towards availability on European markets
    On June 16, 2015, LifeVac Europe received confirmation from the UK Ministry of Health that LifeVac is now registered in the Medicines and Healthcare products Regulatory Agency public access data base. This is the final step towards acquiring the CE mark and making LifeVac available to the entire European market. “We are very excited to […]
  • A few ideas for improving productivity in medical processes
    Drive-based vibration and slosh control can help improve throughput in machines that assemble medical devices and products. Bipin Sen • Ed Lasch Bosch Rexroth Corporation www.boschrexroth-us.com Simply increasing the speed of a system that assembles medical devices, or packages medical products, seems like an easy way to boost throughput – until unwanted vibration (either induced […]
  • ODU announces MEDI-SNAP EMC for next generation medical applications
    ODU, announced ODU MEDI-SNAP EMC, the advanced shielded plastic connector solutions to the US market. ODU MEDI-SNAP EMC is the newest addition to ODU’s Push-Pull circular connectors. The advanced medical connector solution is lightweight, autoclavable, sterilizable and it offers a touch proofed housing and reliable EMI protection at the same time. ODU MEDI-SNAP EMC is available in […]
  • Evaluating the risk of device misconnections: Designing for medical devices with ISO 80369 in mind
    Beginning in the 1990s, concerns grew regarding the proliferation of medical devices fitted with luer connectors and the reports of patient injuries and deaths arising from misconnections. Thus began a many-years process to develop new industry standards for the small-bore connectors used in medical device applications. The much-anticipated ISO 80369 series of standards for small-bore […]
  • Custom molded filter screen assemblies limit contamination and reduce product failure
    Molded screen insert assemblies from Minnesota Rubber and Plastics are custom designed for water, beverage, off-highway and transportation applications to filter out fluid contaminants and reduce product failure. A wide range of screen options are available in many materials for difficult filtration applications allowing use with different fluids. Filter assembly orifice sizes available range from .71 […]

Leave a Reply