10091150Making Dementia a Forgotten Memory – Achieving FDA De Novo for the First Timely and Accurate Dementia Diagnostic TestClosedInvestment AcceleratorInnovate UKDespite rapidly increasing numbers of people living with dementia, there are substantial problems with the timeliness and equity of dementia diagnosis. Around a third of sufferers have not received a diagnosis. People are referred to memory clinics when there is a suspicion that they might have dementia. However, there are other causes of memory difficulty, and often it is impossible to know whether someone has dementia when they are first assessed. Doctors refer to this uncertain situation as "mild cognitive impairment" (MCI). Brain MRI is routinely acquired for these patients, but human interpretation does not reliably predict the underlying diagnosis. Currently, the only way to establish the diagnosis is to follow people over time to see if things get worse. This follow-up is often not available, and so people are discharged without a clear answer. Besides, there is regional variation in diagnosis, and those who are more deprived or from minoritised ethnic groups tend to be diagnosed later and less accurately. Timely diagnosis is important. Those without dementia benefit from early reassurance and treatment for other causes of memory difficulty. For those with dementia, diagnosis enables them to plan for the future, understand their symptoms, and access treatments. Early diagnosis will be even more important when there are treatments that could slow or stop dementia from worsening. The first such treatment was recently approved for use in the USA and submitted to NICE for evaluation. Current NHS infrastructure would be unable to provide the timely diagnosis required for everyone to benefit from such treatments. AINOSTICS aims to solve this problem by developing a proprietary AI solution, BR\[AI\]N, for interpreting brain scans that can predict whether somebody with MCI will develop dementia. It has been awarded FDA Breakthrough Device Designation for its ability to reach an accuracy of 92%. This project aims to build on this success and push towards the FDA De Novo, which is the regulatory pathway for novel medical devices. It can set us apart from our competitors and give us a first-mover advantage in the market. Dr. Wen Ma, the COO of AINOSTICS, will lead this ambitious project. Coming from a multi-disciplinary background, she has successfully established herself in the health tech industry and achieved several milestones for the company. This will be another key achievement led by her, setting her as a role model for young Asian women and encouraging them to join innovation.