The Spine, Paddington Village, Liverpool, England, United Kingdom, L7 3FA
Our mission is to improve healthcare system performance, patient outcomes by delivering better diagnoses, and help create next generation treatments by analysing Cardiac Magnetic Resonance Images, using Artificial Intelligence Algorithms capable of performing the automation of heart measurement to a super-human standard. We do this through the delivery of Core Lab services to pharmaceutical and clinical research organisations
| Device Name | US | UK | CA | AU | EU |
|---|---|---|---|---|---|
| 1CMR Lite UK CA | Not registered with US (FDA) | Registered with UK (MHRA) | Not registered with Canada (Health Canada) | Not registered with AU (TGA) | Not registered with EU (EUDAMED) |
| 1CMR Pro | Registered with US (FDA) | Registered with UK (MHRA) | Not registered with Canada (Health Canada) | Registered with AU (TGA) | Not registered with EU (EUDAMED) |
| EchoConfidence | Not registered with US (FDA) | Registered with UK (MHRA) | Not registered with Canada (Health Canada) | Registered with AU (TGA) | Not registered with EU (EUDAMED) |
| EchoConfidence (USA) | Registered with US (FDA) | Not registered with UK (MHRA) | Not registered with Canada (Health Canada) | Not registered with AU (TGA) | Not registered with EU (EUDAMED) |
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