Commure Ambient AI Achieves Class I Certification and MHRA Registration
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MOUNTAIN VIEW, Calif., Sept. 03, 2026 (GLOBE NEWSWIRE) -- Commure today announced that Commure Ambient AI, its widely deployed AI clinical documentation platform, is CE-marked as Class I medical device software under EU MDR 2017/745 and registered with the UK Medicines and Healthcare products Regulatory Agency (MHRA) under the Medical Devices Regulations 2002. In response to significant demand from health systems across the region, the platform is now commercially available across the UK and Europe. Commure Ambient AI turns clinician-patient conversations into structured clinical documentation in real time, taking on one of healthcare's most persistent burdens. Clinicians review and sign off on every note before it enters the Electronic Patient Record. Under MDR Rule 11, Commure Ambient AI qualifies as Class I because it drafts clinical documentation rather than informing diagnostic or therapeutic decisions, with clinicians reviewing and signing every note. The product is used in more than 50 countries and powers more than 40 million annualized appointments in the US alone for leading health systems including HCA Healthcare and Tenet Healthcare. "Regulatory compliance is fundamental to how we build at Commure," said Dan Warner, President at Commure. "Healthcare's biggest challenges are global, but solving them requires a deeply local approach. Ambient AI's Class I status...
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