Thermo Fisher Scientific’s EXENT System Receives the US FDA’s 510(k) Clearance to Aid Multiple Myeloma Diagnosis
Shots:
- Thermo Fisher Scientific has received FDA 510(k) clearance for the EXENT Analyser & Immunoglobulin Isotypes (GAM) Assay, an automated mass spectrometry-based platform, for aiding diagnosis of MM & related conditions
- The EXENT System detects & isotypes low-concentration M-proteins with high sensitivity to identify them by molecular weight, differentiating endogenous from therapeutic antibodies & providing clear, automated results to enhance diagnostic accuracy & confidence
- EXENT enables high sensitivity, automation, & workflow efficiency with 6hrs. of walkaway time per shift, & is available across the US, Canada, EU, Australia, the UK, Brazil, & New Zealand
Ref: Businesswire | Image: Thermo Fisher | Press Release
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