(RTTNews) - CapsoVision, Inc. (CV), a commercial-stage medical technology company developing imaging and AI-enabled capsule endoscopy solutions, announced the submission of its 510(k) application to the FDA seeking clearance for its proprietary AI-assisted module for CapsoCam Plus.
The company's flagship product, CapsoCam Plus small bowel capsule endoscope system, was granted FDA clearance in 2016. The device, which is a third- generation CapsoCam capsule, provides a novel 360º view of the small bowel for detecting abnormalities.
The addition of the AI-assisted reading module in CapsoCam Plus is intended to improve the detection of clinically significant pathology and reduce clinician review time.
AI-enabled capsule endoscopy solutions integrated artificial intelligence (AI) and profound learning algorithms into the standard capsule endoscopy procedure. A vitamin-sized capsule with a miniature wireless camera captures thousands of images as it travels through the digestive tract.
According to Grand View Research, the global endoscopy devices market was estimated at $61.06 billion in 2024 and is projected to reach $76.55 billion by 2030, growing at a CAGR of 3.79% from 2025 to 2030.
CapsoCam Plus is CapsoVision's third-generation endoscopy capsule system, which offers 360° panoramic imaging for pediatric patients.
Johnny Wang, President and Chief Executive Officer, said, "This submission marks an important milestone in our commitment to customers and patients towards advancing a best-in-class solution that integrates advanced imaging with AI-powered interpretation for small bowel diagnostics"
For the nine months ended September 2025, CapsoVision recorded net revenue of $9.64 million, up from $8.30 million a year ago. However, the firm's net loss for the period widened to $17.92 million from a loss of $15.26 million a year ago.
Over the past year, CV traded between $3.43 and $15.37. On Monday, CV closed trading 10.99% lower at $11.58.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
