Vensana Capital, a medical technology-focused venture capital firm based in Minneapolis and Washington, DC, is submitting this letter in response to the interim final rule delaying the effective date and requesting additional comment on the final rule establishing the MCIT coverage pathway for Food and Drug Administration (FDA)- designated breakthrough medical devices (“Notice of Delay”).1

We urge CMS to move forward with implementation of the MCIT coverage pathway regulation starting on the delayed effective date of May 15, 2021.