Envisioneering's ISO Certification Opens International Market
New Prostate Cancer Diagnostic System Introduced to European Physicians
St. Louis, Mo. (April 18, 2007) St. Louis start-up Envisioneering Medical Technologies has received the International Standards Organization (ISO) 13485:2003 certification, validating the company’s quality system for its TargetScan™ medical device. The ISO certification allows Envisioneering to deliver TargetScan, a first-to-market prostate cancer diagnostic and treatment system, to the European Union and the physicians and patients who inhabit its 27 countries.\
“The credibility of the ISO certification is to the European Union what FDA approval means to the U.S.; it’s absolutely critical for earning our CE mark, mandatory for entering the European Economic Area,” said David Kennedy, director of quality assurance and regulatory affairs for Envisioneering. “The ISO recognition represents a company-wide, nine-month effort that reaffirms our commitment to evolving into a global medical device manufacturer.”
With the certification accomplishment, Envisioneering introduced TargetScan to the European Association of Urology (EAU) at its annual conference held in Berlin. At the EAU in March, European urologists caught a first glimpse at the latest innovation in prostate mapping, biopsy and cancer treatment guidance and, according to Envisioneering, the physicians expressed interest in introducing the device to their patients.
“The EAU’s response to TargetScan confirms that we have created a technology that meets critical health care needs on an international level,” said Robert G. Mills, Envisioneering president. “With our ISO certification and EAU response, we are ready to introduce this technology to a broader geographic physician base. Most importantly, we can deliver this advanced prostate cancer biopsy and treatment technology to more patients around the globe.”
Today, TargetScan is available in select urology clinics across the United States. The device also is in use at some of the nation’s leading urology institutions, including New York University, Washington University in St. Louis and Duke University, to establish a national clinical biopsy registry.
The TargetScan system is unique in that it combines a stationary probe with 3-D imaging and GPS-like prostate mapping. This technology allows physicians, for the first time, to precisely plan and undertake a multi-sample biopsy of a targeted prostate tissue mass and record its exact location. Current procedures require urologists to hold and pivot a probe with one hand, while performing a needle biopsy with the other hand, which some physicians say can lead to missed cancers.
About Envisioneering Medical Technology
Based in St. Louis, Mo., Envisioneering Medical Technologies is dedicated to developing, manufacturing and marketing proprietary diagnostic and treatment technology for the physician community. For more information, please visit www.envisioneeringmedical.com.
About Prostate Cancer
Prostate cancer is the most common type of cancer (excluding skin cancer) diagnosed in American men. Every 2.6 minutes, a new case of prostate cancer is diagnosed, claiming the life of one man every 13 minutes. Last year, roughly 221,000 new cases of prostate cancer were detected in the United States.
|
