Amra Medical today announced that its Amra Mass Scan has received FDA 510(k) clearance.
Sweden-based Amra Medical designed Mass Scan to provide magnetic resonance imaging (MRI) scans using muscle and fat biomarkers. It has a rapid neck-to-knee MRI protocol that produces actionable patient-specific reports.
Reports created by Mass Scan contain the muscle assessment score and precise body composition measurements with contextual insights based on the company’s reference database, as well as anatomic and color-coded segmented images.
“We are very excited to expand this technology to the US. The Amra Mass Scan will greatly benefit patients by allowing clinicians to objectively and accurately assess muscle quality and take action to ultimately improve patient outcomes,” CEO Eric Converse said in a news release. “The beauty of the report is that it is easy-to-understand, it creates a common language among clinicians with the muscle assessment score, and adds only minutes to an already prescribed MRI.”
Amra Medicla’s Mass Scan was also recently permitted for use in Canada.