CarpX Update: The Company plans to provide public update shortly after its concludes the meeting with FDA and will then resubmit the 510(k) after completing additional testing, if any, that the FDA requests. PAVM plans to complete a first-in-human clinical series in New Zealand later this quarter.
Local IRB approval and initiation of patient recruitment is expected in the coming weeks. CE Mark submission for European commercialization is also on target for later this quarter.
EsoCheck Update: EsoCheck is progressing on schedule through two-phase regulatory and commercialization strategy. Dr. Aklog explained. “Phase I seeks to launch initial commercial EsoCheck products in late Q1-2019. The EsoCheck cell sampling device will be submitted for 510(k) clearance later this quarter." Finalizing of Phase II regulatory and commercialization strategy is anticipated to culminate in a PMA pre-submission meeting with FDA in early 2019.
FDA 510(k) submission for PAVmed’s PortIO, DisappEAR and NextFlo is planned in 2019.
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