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Health Canada has issued new guidance for devicemakers on submitting “summary reports” and conducting issue-related analyses of safety and effectiveness for devices approved for marketing in Canada — two requirements recently added to Canadian regulations. Read More
The FDA has released a new action plan that outlines a potential approach to premarket reviews for artificial intelligence (AI) and machine learning-(ML) software modifications. Read More
The FDA’s Center for Devices and Radiological Health (CDRH) is getting ready to launch its Accreditation Scheme for Conformity Assessment (ASCA) pilot program allowing accredited testing laboratories to assess the conformance of a device with FDA-recognized standards. Read More
The assay is meant to be used alongside a clinical evaluation to help determine an acutely ill patient’s risk of moderate or severe acute kidney injury. Read More
The test generates “yes/no” results in approximately 15 minutes, signaling a positive or negative result on the test strip that indicates whether a patient has a high viral load. Read More
Corza Medical will operate in 13 countries in North America, Europe and Asia, and have manufacturing sites in the U.S., Mexico, Germany, China and the UK. Read More