Hoana Medical Acquires CE Mark to Expand Patient Safety Technology to Europ...( CE Mark Opens Market to Mor...),Health

CE Mark Opens Market to More Than 30 European Countries

HONOLULU, Aug. 29 /PRNewswire/ -- Hoana Medical, Inc. announced today that it has successfully completed the intensive regulatory audits for ISO 13485 and the Medical Device Directive (for most European Union countries), which allows the use of the coveted CE Mark -- or Conformite Europeene Mark -- for the LifeBed(TM) Patient Vigilance System. This expands Hoana's patient safety reach to include more than 30 countries in the European Union (EU). The CE Mark is similar to the U.S. Food and Drug Administration (FDA) clearance, which Hoana previously acquired for U.S. markets. It is a mandatory regulatory approval system for all medical devices to be sold in the EU, which indicates that a product conforms to the relevant European health, safety and environmental quality standards. The mark itself is often found on the packaging or actual product offering and is required by most healthcare organizations in Europe.

Traditionally, obtaining CE Mark certification and approval is a rigorous 12- to 18-month process. Hoana is proud to have completed this certification process in under 6 months due to its prior expertise in navigating the FDA clearance process and highly effective regulatory team.

"We are thrilled to have obtained the CE Mark for the LifeBed(TM) Patient Vigilance System," said Dr. Patrick Sullivan, chief executive officer of Hawaii-based Hoana Medical, Inc. "We have received tremendous interest in the LifeBed from hospitals all over Europe and will now be able to partner with them to bring cutting-edge, 24-hour vigilance to their various hospital units. In the U.S., our experience shows that something as simple as finding patients in trouble early makes an enormous difference in their outcome. Using something as simple as the LifeBed to find patients in trouble is clearly enhancing the effectiveness of rapid response teams nationwide -- it's the missing link to solving an
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