Sectra Image Exchange Portal granted CE marking

Regulatory News:

Sectra’s service for the secure transfer of images and patient reports between hospitals, the Sectra Image Exchange Portal (Sectra IEP), has been CE marked. CE marking confirms that the product meets all the requirements of the European Medical Device Directive (MDD 93/42/EEC) and that Sectra IEP is clinically safe and effective for its intended purpose.

"Many suppliers choose not to CE mark this type of system for information exchange and administration in medical care,” says Torbjörn Kronander, President and CEO at Sectra.

"However, we believe it is very important that our products offer a high level of clinical safety. For example, Sectra was one of few suppliers that CE marked a radiology information system (RIS) when authorities and legislators understood that this type of system was gaining increasingly advanced functions with a significant potential impact on patient safety.”

CE marking activities stretch beyond development and also include validation, installation, user training, service, support and post-market surveillance (such as clinical incident management and clinical feedback).

About Sectra IEP

The Image Exchange Portal (IEP) allows healthcare professionals to securely transfer patient images and reports from one hospital to another. IEP eliminates the costly production of CDs, streamlines radiology reporting and improves the patient experience.

About Sectra

Sectra was founded in 1978 and has its roots in Linköping University in Sweden. The company’s business operation includes cutting-edge products and services within the niche segments of medical systems and secure communication systems. Sectra has offices in 12 countries and operates through partners worldwide. Sales in the 2013/2014 fiscal year totaled SEK 853 million. The Sectra share is quoted on the NASDAQ OMX Stockholm AB exchange. For more information, visit www.sectra.com (http://www.sectra.comIn) 

In the medical market, Sectra develops and sells IT systems and services for radiology and other image-intensive departments, orthopaedics and rheumatology. More than 1,700 hospitals, clinics and imaging centers worldwide use the systems daily. This makes Sectra one of the world-leading companies for handling digital radiology images. In Scandinavia, Sectra is the market leader with more than 50% of all film-free installations. Sectra’s systems have been installed in North America, Scandinavia and most major countries in Europe and the Far East.

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