Verge Medical, Inc.

Verge Medical, Inc. specializes in angioplasty balloon catheters, which are used to widen narrowed or blocked blood vessels. Their primary focus is on two categories: peripheral angioplasty balloon catheters (for non-heart arteries) and coronary angioplasty balloon catheters (for heart arteries). Examples include the FLASH Ostial System and FLASH MINI Ostial System, which are designed for precision treatment of ostial lesions—blockages at the openings of arteries.

Verge Medical, Inc. is headquartered in the United States. Since the company operates within the U.S., its devices are subject to FDA regulations. The FDA classifies these devices as Class II, which requires premarket notification (510(k)) and Unique Device Identification (UDI) authorisation before they can be marketed. This classification reflects the moderate risk associated with angioplasty catheters, necessitating compliance with specific regulatory pathways.

Verge Medical, Inc.’s devices are listed in the FDA’s 510(k) and Unique Device Identification (UDI) registries. The 510(k) pathway demonstrates that each device has been authorised as substantially equivalent to a legally marketed predicate device, while the UDI system ensures traceability and identification of the devices in the market. These registries are critical for tracking and verifying the authorised status of their angioplasty balloon catheters.

Verge Medical, Inc.’s devices are classified as Class II under FDA regulations. This classification is based on the moderate risk they pose to patients, as angioplasty catheters require precise placement and control to avoid complications like vessel perforation or dissection. Class II devices require premarket submission (like the 510(k)) to ensure safety and effectiveness, but they do not undergo the stringent clinical trials required for Class III devices. This classification balances regulatory oversight with operational feasibility for manufacturers and healthcare providers.