SyntheticMR AB (publ)

SyntheticMR AB (publ) specializes in MRI system application software. Their primary focus is on tools like SyMRI, which automates the generation of synthetic MRI images from standard sequences. These software solutions are designed to streamline imaging workflows by producing multiple contrast-weighted images without requiring additional patient scans, thereby enhancing efficiency and diagnostic capabilities.

SyntheticMR AB (publ) is headquartered in the United States. The company’s location is relevant for understanding regulatory frameworks, market reach, and compliance considerations for its MRI software products.

SyntheticMR AB (publ)’s devices fall under the FDA’s Class II classification. This classification is typically assigned to devices that pose moderate risk and require special controls to ensure safety and effectiveness, such as software that influences MRI imaging workflows and diagnostic outcomes.

Yes, SyntheticMR AB (publ)’s devices are included in the FDA’s Unique Device Identifier (UDI) database. Listing in the UDI database is a requirement for medical devices in the U.S., ensuring traceability, tracking, and compliance with regulatory standards for devices like SyMRI, which are designed to enhance MRI imaging processes.