Hong Kong – Korea’s Ministry of Food and Drug Safety (MFDS) is looking to establish an international common set of guidelines for AI medical devices after its election to the first Chair of Artificial Intelligence Medical Devices (AIMDs) at a meeting of the International Medical Device Regulators Forum (IMDRF).
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Boston Scientific, Channel Medsystems, Lifesignals, OralDNA Labs, Paige.
The U.S. FDA announced July 18 that it has granted an emergency use authorization (EUA) to Quest Diagnostics Inc. for the company’s real-time, reverse transcriptase polymerase chain reaction test for the SARS-CoV-2 virus in a development that FDA commissioner Stephen Hahn described as “an important step forward.”
The U.S. FDA has given the green light to Xact Robotics Ltd. for its Xact Ace robotic system for computer tomography (CT)-guided percutaneous procedures. The company plans to roll out the system later this year with an initial focus on interventional radiologists.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Fx Solutions, Luminex, Neumodx, Phase Scientific.
The U.S. FDA’s interest in harmonizing its regulations for medical devices with an international standard is a matter of record, but the agency has found this to be an enormously complicated task. Kim Trautman, executive vice president for medical device services at NSF International, of Ann Arbor, Mich., told BioWorld that the task of rewriting Part 820 to meet ISO 13485 in the middle is no mean feat, but also that it may be delayed again, this time because of the COVID-19 pandemic.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ambu, Bristol-Myers Squibb.
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