Priority review for Alzheimer’s diagnosis device from Altoida
Lucerne/Houston – Altoida will be able to accelerate the approval procedure for its Alzheimer’s diagnosis device. To this end, the US Food and Drug Administration (FDA) has awarded Breakthrough Designation to the Lucerne-based firm’s device for predictive digital biomarkers.
Altoida has been awarded Breakthrough Designation by the US Food and Drug Administration for its precision neurology device to predict the onset of Alzheimer’s disease. First rolled out in 2012, this classification accelerates the approval process for drugs and devices used to treat serious or life-threatening diseases. As part of this program, the Altoida device will be subject to priority review. Moreover, this special procedure will offer the company interactive communications with regard to product development, conducting clinical trials and taking decisions in relation to commercialization activities.
The non-invasive software device measures and monitors neurocognitive functions. According to a press release, it can use personalized brain data with the help of Artificial Intelligence (AI) to predict whether or not a person aged 55 or over with mild cognitive impairment will develop Alzheimer’s disease within twelve months. At present, further clinical studies are being carried out.
“We are proud to receive this designation for the Altoida device”, comments Travis Bond, CEO of Altoida, before adding: “This significant milestone enables Altoida to pioneer a new generation of precision neurology devices which leverage artificial intelligence for prediction of neurodegenerative disorders before onset, rather than rely on analysis of symptoms after onset”.
Ioannis Tarnanas, Chief Scientific Officer of Altoida, underlines the company’s commitment to “reinventing traditional approaches in dementia diagnosis”. The Altoida device could enable preventative and therapeutic interventions at the earliest stages, which in turn could help to delay onset as well as improving the clinical outcomes.
