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Showing posts with the label medical

AI solutions package released for identifying and triaging stroke

Aidoc , a provider of AI solutions to radiologists, has released its complete AI package for the identification and triage of stroke in CT scans. The CE-marked solution flags and prioritises vascular occlusions which result in both ischemic and haemorrhagic strokes. The stroke package, comprising the new CE-marked Large-Vessel Occlusion AI module and Aidoc’s already FDA-cleared and CE-marked intracranial hemorrhage AI module reduces “door-to-needle” time for patients suffering from stroke. Dr. Eyal Morag, medical director of Aidoc, said: “When creating an AI solution for stroke, it’s all about providing solutions where time matters most. Aidoc augments the radiologist’s workflow with life-saving technology, assuring medical providers that there are no delays in treatment for patients suffering from a stroke – be it haemorrhagic or ischemic.” Aidoc’s complete stroke package ensures that both ischemic and haemorrhagic stroke sufferers are prioritised in worklists immediately. The...

Cleaning Validation - Current Regulatory expectations, A Different Perspective

A gap in the effective cleaning procedures raises critical concerns over the integrity of product quality, safety and efficacy, in just the same way critical data integrity issues result from a gap in data. The perception in validation circles that cleaning validation is a generic version in the list of validations may not be right, since cleaning validation requires the use of different Acceptance Criteria for deciding the effectiveness of cleaning. Having said this, cleaning validation professionals are left wondering how to fix issues, how effective the correct approach is, how to design and perform the cleaning validation studies, etc. How valid are the traditional concepts in the light of changing expectations from the regulatory agencies? The way out is to employ a risk based approach to design a cleaning validation plan, as the rationale and procedures being used by most companies are turning out to be low on reliability. A meaningful learning session from Traininng.c...