CapsoVision Clears AI Highlights for U.S. Launch

The Tip Desk · November 13, 2026 · 3 min read

Third-quarter revenue was $3.6 million as the company posted a $7.3 million net loss, or $0.15 a share, and raised cash to $21.8 million.

CapsoVision, Inc. (CV), a commercial-stage medical technology company developing imaging and AI-enabled capsule endoscopy, received FDA clearance on September 25, 2026 for AI Highlights, its AI-assisted reading tool for CapsoCam Plus, and launched the product commercially in the United States on November 2, 2026.

The company said it expects the addition of AI Highlights to accelerate CapsoCam Plus sales growth, with the full commercial impact anticipated in 2027. The tool is available for adults and pediatric patients aged two and older and supports physician review through local computer and cloud-based platforms.

Third-quarter revenue was $3.6 million, compared with $3.5 million in the third quarter of 2025. Average selling price was stable year over year. CapsoCam Plus had been used by more than 184,000 patients worldwide as of September 30, 2026, compared with 151,000 a year earlier.

Gross profit was $1.8 million, and gross margin was 49%, compared with 54% a year earlier. The company said the decline primarily reflected higher material costs associated with increased flash memory prices, a one-time inventory obsolescence charge, and higher stock-based compensation expense.

Operating expenses decreased to $9.1 million, from $9.9 million in the third quarter of 2025. The company said the decline reflected continued expense management while supporting clinical and development programs, including the CapsoCam Colon pivotal study. With that study now complete, it expects related clinical expenses to decline while it continues advancing its development pipeline.

Net loss was $7.3 million, or $0.15 a share, compared with a net loss of $7.9 million, or $0.17 a share, a year earlier.

CapsoVision completed enrollment and clinical data collection for the second-generation CapsoCam Colon study, including physician review of capsule videos both with and without AI assistance. An FDA 510(k) submission remains on track for year-end 2026.

The company also continued expanding the clinical footprint of the CapsoCam UGI study for pancreatic cancer detection. Building on two active community-based clinical sites, it executed a clinical trial agreement with a third site and is in various stages of contracting and feasibility discussions with more than a dozen larger medical centers with expertise in pancreatic ductal adenocarcinoma, which the company expects will help accelerate patient enrollment.

Cash and cash equivalents totaled $21.8 million as of September 30, 2026. During September, the company completed an $18 million registered direct offering with existing shareholders, generating approximately $17.8 million in net proceeds. It also sold 276,446 shares through its at-the-market offering program during the quarter for approximately $1.7 million in net proceeds.

President and Chief Executive Officer Johnny Wang said the FDA clearance and subsequent U.S. launch of AI Highlights marks an important step forward. He said the company believes combining panoramic imaging with FDA-cleared AI-assisted review, approved for use in patients two years and older, is a meaningful differentiator for CapsoCam Plus, and that completing enrollment in the colon clinical study brings the company closer to a planned FDA submission by year end.