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FDA has posted hypothetical PCCP examples covering continuously learning and site-adapted AI, and MHRA plans draft PCCP guidance by year’s end. Officials from both agencies say they are looking past rigidly locked updates toward defining performance “envelopes” for devices that keep learning.
In this month's news, 510(k)s for several AI image analysis tools, Steris buys Xodus Medical for $2.1 billion, developments in the Delphi and READI-Home programs for patient-used products, and more.
Medtech groups formally respond to CMS’ RAPID proposal for regulatory-reimbursement alignment. Excerpted from Pathways Picks October 14: RAPID Response, Notified Body Needs, CDRH Retirement, and More.