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Class I Ce Marked Medical Device Articles & Analysis
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STEMart, a US-based provider of comprehensive services for all phases of medical device development, announces the expansion of its medical device testing capabilities and introduces Balloon Catheter Testing Services for the development of safe and effective medical devices. These reliable testing solutions will meet the evolving needs of the medical device industry and help manufacturers ...
BySTEMart
Oncomfort has just launched SILVA, a new module that enriches its library of solutions for the treatment of anxiety and pain for patients undergoing a medical procedure. SILVA, which features a walk in the forest, is aimed at inducing a state of dissociation comparable to moderate or deep sedation, and is particularly suitable for populations suffering from respiratory disorders. SILVA uses a ...
Epihunter, which last year earned the European CE mark as a class I medical device, is today also launching a new offering towards the B2B market. ...
Infection control procedures including work practices, protocols and controls, environmental hygiene, air filtration and appropriate use of Personal Protective Equipment (PPE) are all necessary to prevent infections from spreading during healthcare service delivery. But in the case of the recent Coronavirus (COVID-19) outbreak early detection and isolation of potentially infectious patients is ...
“Boston Children’s Hospital’s clinicians and researchers have extensive experience in setting up and running medical device studies, including those involving seizure monitors. We are eager to measure epihunter’s impact on therapy decision making and daily life,” Rotenberg adds. ...
Thermo Fisher Scientific has expanded its portfolio of analytical instruments for clinical diagnostic laboratories with the addition of three systems now listed as Class I medical devices with the United States Food and Drug Administration (U.S. FDA). The portfolio enables clinical diagnostic laboratories to leverage a comprehensive platform for developing sensitive and reliable laboratory ...
It is estimated that 1 in 100 people have epilepsy, and 1 in 3 people with epilepsy continue to experience uncontrollable and unpredictable seizures despite medication. Motor seizures, which manifest as repeated automatic movements and unconsciousness, is what most people think of when they hear the word ‘seizure’. ...
Belgian startup, epihunter, introduces automated video functionality to their CE-marked seizure detection app - a breakthrough for children and adults with epilepsy, their families and doctors. ...
Waters Corporation (NYSE: WAT) today announced that the Waters® ACQUITY UPLC® I-Class IVD/Xevo® TQ-S micro IVD System is now manufactured as a U.S. FDA Class I medical device and is CE Marked to the European Directive 98/79/EC (IVDD). ...