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Limbus Medical Technologies Gets IVDR Class C Certification for Genomics Software

NEW YORK — German medical device and software developer Limbus Medical Technologies said Friday that it has received European In Vitro Diagnostic Medical Device Regulation (IVDR) Class C certification for its Varvis genomics-based clinical diagnostics decision support system.

The cloud-based Varvis platform allows clinicians to filter and evaluate genetic sequencing data including raw data processing, genomic data management, and variant interpretation, according to Limbus.

"To our knowledge, the Varvis software is the first Class C software that covers the entire process from raw data to genomic variant classification," Sonja Strunz, head of regulatory affairs at Limbus, said in a statement. "Both SNV/Indel and CNV analysis are covered by our IVDR certificate."

Most molecular devices are regulated under Class C of Europe's IVDR. Class C covers in vitro diagnostic devices that represent a medium to high risk to the general population but lesser risk than Class D devices.