IQ-AI said US regulator the FDA has now determined that its IB Zero G MRI alternative is a novel technology.
In the response, the FDA provided several alternatives including a "de novo" application for approval.
The de novo pathway is specifically designed for novel medical devices and allows the FDA to review new technologies more expeditiously such that patients can have access to safe and effective medical devices sooner, said teh statement.
Previously new devices were put into the highest risk category but IQ-AI does not believe this is appropriate for IB Zero G and will talk to the FDA for further clarification and to utilise the de novo pathway.
IQ-AI also reported revenues of £256,000 in the half year to end-June 2022, reflecting renewal subscriptions of IB Clinic. Half-year losses were £331,000.