CapsoVision, Inc 8-K

What Happened
On December 29, 2025, CapsoVision, Inc. (NASDAQ: CV) announced that it submitted a 510(k) application to the U.S. Food and Drug Administration (FDA) for its proprietary AI-assisted module for CapsoCam Plus®. The company filed a press release about the submission as Exhibit 99.1 to its Current Report on Form 8-K, which was signed by President and CEO Kang-Huai (Johnny) Wang.

Key Details

• Submission date announced: December 29, 2025.
• Regulatory pathway: 510(k) premarket notification to the FDA (seeking clearance, not an approval).
• Product: proprietary AI-assisted module for CapsoCam Plus®.
• Press release describing the submission is included as Exhibit 99.1 to the 8-K.

Why It Matters
A 510(k) submission is a formal step toward FDA clearance that, if granted, would allow the company to market the AI-assisted module in the U.S. This filing signals regulatory progress for CapsoVision’s product development; however, the filing itself is not FDA clearance and does not guarantee a marketing authorization. Investors should view this as a material regulatory update on the company’s efforts to expand its device capabilities.