implantable physiological monitor — NDA/BLA submission
Late 2026
We plan to make our 510(k) submission for the implantable monitor, which could happen as early as late 2026, if and to the extent resources permit us to do so.Source filing
PAVMED INC · Data as of 2026-09-08
Late 2026
We plan to make our 510(k) submission for the implantable monitor, which could happen as early as late 2026, if and to the extent resources permit us to do so.Source filing
4Q26
Advanced PortIO's FDA pre-submission process, with FDA meeting request planned for 4Q26.Source filing
early 2027
Continued development of the implantable physiological monitor toward an early 2027 FDA 510(k) submission, with design freeze nearing completion and manufacturing test runs performing well in preliminary verification and validation ahead of final clinical testing.Source filing