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The ultimate goal of verification and validation testing is to show that there is a minimal risk that a device will not perform as intended. To prove this to the FDA’s statistical satisfaction, companies must select sample sizes that will accurately reflect the real risk. To do this, devicemakers need to consider several factors. Read More
The medical device industry finds the FDA’s draft guidance on reporting medical device and diagnostic shortages during public health emergencies (PHEs) too far-reaching and too burdensome. Read More
Medtronic was sued Tuesday by the widow of a type 2 diabetes patient who alleges his death was caused by the company’s MiniMed 630G insulin infusion pump. Read More
The FDA has issued a nine-observation Form 483 to Sacks Holdings, based on an inspection last December of the company’s facility in San Diego, Calif. Read More
The FDA has launched an initiative to strengthen the device supply chain against future disruptions like those caused by the current pandemic. Read More
An artificial intelligence (AI)-enabled image analysis technology from PreciseDx has successfully diagnosed Parkinson’s disease in living patients prior to the onset of severe symptoms. Read More