Subtle Medical announced that its AI-powered MRI enhancement technology SubtleHD™ has obtained ANVISA regulatory approval and is now commercially available in Brazil, representing a major milestone in the company's Latin American expansion strategy. The company has partnered with Hospiline, a regional distributor, to support growth throughout Brazil and Chile.
Addressing Critical Infrastructure Gaps
SubtleHD™, an FDA-cleared and CE-marked deep learning technology, enhances MRI image quality while delivering up to 80% faster scan times in some sequences. The technology seamlessly integrates into existing workflows and extends the life and performance of current MRI scanners—a critical capability in Brazil, where imaging infrastructure significantly lags behind global benchmarks.
Brazil currently has approximately 14.5 MRI units per million people, falling below the global average of 20.7 units per million. Despite this limited infrastructure, national estimates indicate the need for 30,000 MRI exams per million inhabitants annually, translating to approximately 6 million MRI scans per year across Brazil's 2,349 MRI systems.
Operational Efficiency Gains
As patient volumes increase, public institutions often face extended wait times, while many providers contend with aging equipment and constrained budgets. Over 66% of MRI scanners in the region are more than six years old, yet demand for MRI exams continues growing rapidly.
SubtleHD™ empowers imaging providers to unlock additional scan slots without requiring new hardware investments, boosting operational efficiency and patient throughput. Brazilian healthcare institutions can now benefit from improved image quality even on older MRI systems, faster exam times to help reduce patient backlogs, and vendor-neutral compatibility with existing infrastructure.
Strategic Partnership and Market Impact
"We're excited to introduce SubtleHD™ in Brazil," said Josh Gurewitz, Chief Commercial Officer at Subtle Medical. "With Hospiline's support, imaging providers across the country can now harness AI to bridge infrastructure gaps, elevate diagnostic confidence, and improve productivity—all while enhancing patient care."
The technology is already deployed globally across more than 900 scanners worldwide. Subtle Medical has been recognized as a CB Insights GenAI 50 company and twice named among the CB Insights Top AI 100 and Digital Health 150, reflecting its leadership position in AI-powered medical imaging solutions.
Regional Expansion Strategy
The Brazil launch follows Subtle Medical's earlier commercial availability announcement in Chile, also distributed through Hospiline. This partnership approach enables the company to leverage regional expertise while addressing the specific infrastructure challenges facing Latin American healthcare systems.
Hospiline serves as a trusted distributor of advanced medical technologies throughout Latin America, partnering with leading healthcare innovators to bring modern, effective technologies to hospitals, clinics, and imaging centers across the region.
