In the Shark Tank session, the main concerns expressed were about how this test will fit with Clinical Laboratory Improvement Amendments (CLIA) compliance. Herb Lerner, MD, a former officer in the Food and Drug Administration (FDA) and now senior director of medical and regulatory affairs at Hogan Lovells, a Washington, D.C.–based law firm, urged Dr. Kim to approach the FDA as soon as possible for advice on how to address this and other potential obstacles to a commercial product.
GI endoscopy capture, storage, and sharing
In introducing an automated method of capturing videos taken during colonoscopy, Matthew Z. Schwartz, the cofounder of Virgo Surgical Video Solutions, Inc. said, “There is currently no low-cost, user-friendly way to systematically capture GI endoscopy video.” Relative to existing products that “require complicated formatting and time-consuming setup for each procedure recording,” the plug-and-play system developed at Virgo “works with any existing endoscopy system that has a video output.” The videos are designed for cloud storage.
“Our long-term vision is to create the largest and highest quality repository of GI endoscopy videos,” said Mr. Schwartz, who added that support tools, including clinical decision-making aided by artificial intelligence, are being developed to provide even more value for quality control, research, and training.
Several Sharks, including Tom Shehab, MD, managing director, Arboretum Ventures, Ann Arbor, Mich., asked for more information about the value proposition for a proposed cost of $500 per month for the system. The answer was that this value would differ for settings, such as in an academic center that might apply the system for training relative to a community setting where the main purpose might be quality improvement.