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Percussionaire was handed a Form 483 following an inspection of its Sandpoint, Idaho facility for not reporting a serious medical event and for not properly handling and reporting a firmware issue with some accessory devices. Read More
The FDA issued an update on Baxter Hillrom’s Sept. 30 recall of its WatchCare incontinence management system, declaring it a Class 1 recall because of the risk of serious injury or death. Read More
Lunit’s study of 55,579 mammograms showed an increased cancer detection rate and a lower patient recall rate using the company’s Insight MMG breast cancer artificial (AI) solution than a team of two radiologists, the South Korea-headquartered company reported. Read More
Companies need to know how to access their archives — day or night — when using a third party for document storage and preparing for an FDA inspection, an FDA inspections expert advised at the WCG FDAnews Annual FDA Inspections Summit in Washington, D.C., Nov. 16-18. Read More
John Hopkins Kimmel Cancer Center in Baltimore, Md., used artificial intelligence (AI) blood test technology to detect more than 80 percent of liver cancers in current liver cancer and at-risk patients. Read More
The FDA has released a cybersecurity action plan that aims to incrementally take the agency to a “zero trust” environment meant to strengthen the FDA’s ability to protect sensitive information and decrease overall security risks to the agency. Read More