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Class I 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. ...
BySTEMart
The Digital Sedation™ modules are adapted to a large range of interventions, to the different phases of the medical journey - before, during or after procedures - and to the specific characteristics of the patient, such as age and language. This therapeutic technique also offers many advantages to medical staff, such as enhanced procedural conditions - ...
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 ...
“The goal of our research grants program is to accelerate the development of new therapies and diagnostic devices so that we can get them to people with epilepsy faster, and in a time frame that matters,” says Sonya Dumanis, PhD senior director of Innovation, Epilepsy Foundation. ...
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. ...
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’. ...
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’. ...
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). ...