DiaMentis’ innovative mental health diagnostic technology accepted into FDA breakthrough device program
QUEBEC, December 17, 2020 / CNW Telbec / – diaMentis announces that its mental health diagnostic technology has been accepted into the Breakthrough Devices program of the United States Food and Drug Administration (FDA). Once approved, this technology could provide primary care physicians and psychiatrists with an objective method of diagnostic decision-making, especially for patients with bipolar disorder or schizophrenia.
A world first
There are currently no tools available to help with mental health diagnoses anywhere in the world. This is an important recognition because, at present, diagnoses in this area are based only on the observation of clinical signs and symptoms and can take, in some cases, up to 5 or 7 years to be established. confirmed. In the absence of appropriate medical technology, such delays and uncertainties can contribute to the increase in severity and severity of these diseases.
“Time is a key success factor for people with mental illness. The diaMentis diagnostic tool could have a very significant impact on their life and that of their family. The speed and power of our new technological approach will likely be of great benefit to healthcare professionals facing mental health issues. The sooner these diseases can be identified, the sooner we can hope to provide adequate care and reduce long-term negative effects, ”said the President and CEO of diaMentis, Normand Tremblay.
“The technology we are developing makes it possible to analyze the information obtained from an electroretinogram, a simple, non-invasive eye examination. By developing new proprietary analysis methodologies and constructing mathematical models better suited to the biomarkers expressed in various mental illnesses, we can add objective measurement to the diagnostic process. This designation will allow us to interact with the FDA in order to leverage our technology development more effectively, ”added Vice President and Chief Scientific Officer, Dr. Claude hariton.
The FDA’s Fast Track Program
The Breakthrough Devices program is an FDA program designed, among other things, for innovative medical devices that allow more effective diagnosis of life-threatening or irreversible debilitating diseases, such as certain mental illnesses. The goal of the Breakthrough Devices program is to provide patients and healthcare providers with rapid access to this technology by accelerating its development and review, while maintaining high FDA standards.
QuebecThe developer of medical technologies diaMentis is a pioneer in the development of diagnostic aids for various mental health disorders. It was established in Quebec in 2015 and employs 23 people full time. As a spin-off of the University from Laval Research work by the Institut en santé Mental du Québec (IUSMQ), diaMentis is developing exclusive methods for the analysis of biomarkers present in retinal signals. For more information visit www.diamentis.com.
For more information: Valérie Chamula, Citizen, [email protected], 418-809-1180