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.

纽约-德国医疗设备和软件开发商Limbus medical Technologies周五表示，其基于Varvis基因组学的临床诊断决策支持系统已获得欧洲体外诊断医疗设备法规（IVDR）C级认证。

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.

Limbus表示，基于云的Varvis平台允许临床医生过滤和评估基因测序数据，包括原始数据处理，基因组数据管理和变异解释。

'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.'

Limbus监管事务负责人索尼娅·斯特伦茨（SonjaStrunz）在一份声明中说，据我们所知，Varvis软件是第一款C类软件，涵盖了从原始数据到基因组变异分类的整个过程我们的IVDR证书涵盖了SNV/Indel和CNV分析。”

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.

大多数分子设备受欧洲IVDR C类监管。C类包括体外诊断设备，这些设备对普通人群具有中等至高风险，但风险低于D类设备。