CapsoVision, Inc. Announces FDA Clearance for AI Highlights™

What Happened
CapsoVision, Inc. announced on September 28, 2026 (Form 8-K filed) that its AI-assisted reading feature, AI Highlights™, for the CapsoCam Plus® system received clearance from the U.S. Food and Drug Administration on September 25, 2026. The company attached a press release as Exhibit 99.1 to the Form 8-K; the report was signed by President and CEO Kang-Huai (Johnny) Wang.

Key Details

• FDA clearance granted for AI Highlights™ on September 25, 2026.
• Current Report on Form 8-K filed and dated September 28, 2026 (Exhibit 99.1 = press release).
• AI Highlights™ is an AI-assisted reading feature for the CapsoCam Plus® capsule endoscopy system.
• Report signed by CEO Kang-Huai (Johnny) Wang.

Why It Matters
Regulatory clearance from the FDA is a key step for CapsoVision to market and deploy the AI-assisted feature in the U.S., which could improve the CapsoCam Plus® product offering and workflow for clinicians. The filing does not include financial results or projections, so investors should view this as a product/regulatory milestone rather than a direct financial update.