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news.Hawaii-based healthcare company Hoana Medical has completed the intensive regulatory audits for ISO 13485 and the medical device directive, which allows the use of the CE mark for the LifeBed patient vigilance system.
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The CE mark expands Hoana’s patient safety reach to include more than 30 countries in the EU.
Hoana’s technology is said to transform any hospital bed into a LifeBed, which invisibly tracks a patient’s basic vital signs without any connection to the patient whatsoever.
Patrick Sullivan, CEO of Hoana Medical, said: “We are thrilled to have obtained the CE mark for the LifeBed patient vigilance system.
“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.”