News

FDA certifies matrix switching systems, extenders for medical applications

July 15, 2016

PureLink announced that its PureMedia Signal and Data Distribution Solutions have received approval by the U.S. Food and Drug Administration and have been deemed compliant with applicable performance and safety standards regarding electromagnetic interference and radio-frequency interference for electronic products.

The company said its product line, including matrix switcher chassis, input and output cards, and extenders, is currently the only FDA-cleared A/V signal processing and management system certified safe for use in medical applications in patient-facing facilities.

"This acknowledgement by the FDA further validates the stringent quality and safety standards we have always engineered into our products," said Howard Schilling, PureLink's director of sales. "For our customers in the medical and healthcare vertical, this officially authorizes the PureMedia line for use in patient-facing environments such as operating rooms, ICUs, and long-term patient care facilities."

The FDA's Center for Devices and Radiological Health compiles an annual Electronic Product Report that assesses and categorizes the radiation safety performance standards of devices from manufacturers that are submitted for approval. Certification means that the manufacturer of a radiation-emitting electronic product states that the product complies with an applicable FDA performance standard and does not emit hazardous and unnecessary radiation. Examples of non-medical electronic products covered by these standards include television receivers and monitors, video displays, entertainment lasers, cordless and cellular telephones, laser CD players and other related equipment and devices, the release said.