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AXIM Biotechnologies Submits 510(k) to FDA for Next-Generation, Rapid Point-of-Care Tear ...

Published

6 October 2026

Topic

opportunities

◆ Sectors

Diagnostics

◆ Geography

United States

◆ Source

Read at eqs-news.com →

◆ Verified

Fusion42 · 6 October 2026 · Fusion42 review

AXIM Biotechnologies has submitted a 510(k) premarket notification to the FDA for its next-generation rapid lateral-flow tear lactoferrin test to diagnose aqueous deficient dry eye disease, aiming for a CLIA waiver to enable broader point-of-care use.

This Wire brief sits within Fusion42's coverage of Diagnostics.

◆ ◆ The Wire takeaway

Your dry eye diagnostic can move out of specialist labs and into everyday clinics once AXIM’s test gains CLIA waiver. This opens rapid, objective testing to more patients and puts pressure on competitors to streamline their diagnostics.

◆ Coverage

1 source · 6 Oct 2026

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◆ Topics

Diagnosticsdry-eyefda-510kpoint-of-carediagnosticslactoferrincli-waiver