Hyperfine shares surge 11.76% after-hours after securing India's CDSCO approval for Swoop portable MRI system.

Hyperfine surged 11.76% in after-hours trading following regulatory approval of its Swoop portable MRI system in India, granting access to a major healthcare market with significant unmet demand. The Central Drugs Standard Control Organization (CDSCO) clearance enables commercialization in India, where the company partners with Radiosurgery Global Ltd. to distribute the system. This expansion aligns with Hyperfine’s global growth strategy, as the Swoop system’s portability, affordability, and low infrastructure requirements address barriers to MRI access in India’s diverse healthcare landscape. Additional positive momentum came from the company’s Q4 2025 revenue of $5.3 million, a 127% year-over-year increase, and a 30% reduction in net cash burn compared to Q4 2024, signaling improved financial efficiency. The India approval and strong revenue growth outweighed concerns about ongoing cash burn, driving the after-hours rally.