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Medicare begins paying for Lucid's EsoGuard as PAVmed's Veris nears FDA 510(k) filing

🇺🇸 PAVmed Inc. (PAVM) · Fri 13 Nov 2026

PAVmed's preliminary Q3 update says Lucid has been paid by Medicare since October, while Veris Health has frozen its monitor design and started an animal study ahead of an early-2027 submission.

PAVmed Inc. reported preliminary third-quarter 2026 results and a business update on 13 November. Its main commercial development is that Lucid Diagnostics began receiving Medicare payments in October for EsoGuard, a DNA test for esophageal precancer.

The claims are billed to Novitas, the Medicare Administrative Contractor (MAC), at the established Clinical Laboratory Fee Schedule rate. The update gives no further detail on payment volumes or timing beyond what is summarised here.

On the device side, Veris Health has frozen the design of its implantable monitor and started a 90-day animal study conducted under Good Laboratory Practice (GLP). The company is targeting an FDA 510(k) submission in early 2027.

PAVmed also said that PortIO and Octeris have begun engagement with the FDA. The summary does not specify the scope or stage of those discussions.

For context, a 510(k) is the premarket notification route in which a manufacturer shows that a device is substantially equivalent to a legally marketed predicate device.

What it means for your team

  • Market-access teams in diagnostics can note that Medicare payment for EsoGuard is being made at the existing Clinical Laboratory Fee Schedule rate through MAC Novitas.
  • Regulatory teams tracking implantable monitoring devices should watch for the Veris 510(k) submission, expected in early 2027 after the 90-day GLP animal study.
  • Quality teams may note that the design freeze preceded the GLP study, a sequence relevant to design-control documentation for the eventual submission.
  • The FDA engagement by PortIO and Octeris is at an early stage and no timelines were given.

Company's press release (SEC filing): PAVmed Inc. ↗

Article written by VigiEye from the official source (PAVmed Inc.). Claims are the company's own. AI-assisted; check the source before acting.

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