Venus Concept shares surge 19.69% premarket after FDA clears Venus NOVA for U.S. launch in December 2025.

Venus Concept surged 19.69% in premarket trading following FDA 510(k) clearance for its Venus NOVA platform, a next-generation multi-application device for non-invasive body, face, and skin treatments. The approval, announced November 10, 2025, enables U.S. commercial availability in December 2025 and global rollouts in 2026. The platform integrates Adaptive EMS, (MP)² RF+PEMF, and IoT connectivity via Venus Connect, positioning it as a key product under the company’s new R&D strategy. Management highlighted the device’s potential to address unmet needs in the body and skin aesthetics market, including GLP-1-related skin laxity, and emphasized financial support from Madryn Asset Management as part of its turnaround plan. The clearance provides a clear commercial pathway, with clinics expected to adopt the Venus Jumpstart Program for integration, aligning with the stock’s sharp premarket rise driven by regulatory progress and long-term growth expectations.