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In this week’s Pathways Picks: FDA considers autonomous and remote robots, adds flexibility to emergency diagnostic testing, and proposes 510(k)s for more companion diagnostics; medtech and the midterms; CMS delays remote monitoring payment restrictions, finalizes pass-throughs, and adds DME latitude; EU adopts updated standards and makes a pact with Singapore; and more global policy updates.
In September, a high-profile FDA advisory committee panel recommended regulatory approval of GRAIL’s multi-cancer early detection screening test, paving the way for a new paradigm in diagnostics. Wall Street and companies working on MCEDs responded favorably, and GRAIL’s stock jumped. The panel opinion has nuances, however, and the next steps will be critical in sorting out an opportunity that is guaranteed to be complicated, as well as exciting.
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.