top of page

Press release

diaMentis innovative mental health diagnostic technology has been accepted into the FDA Breakthrough Devices Program


QUEBEC, Dec. 17, 2020  - diaMentis announces that its mental health diagnostic technology has been accepted in the U.S. Food and Drug Administration (FDA) Breakthrough Devices Program. Once approved, this technology could provide primary care physicians and psychiatrists with an objective method for diagnostic decision-making, especially for patients suffering from bipolar disorder or schizophrenia.

A world premiere
There are currently no tools available to assist with mental health diagnoses anywhere in the world. This is an important recognition because, at the moment, diagnoses in this field are based solely on observation of clinical signs and symptoms and can take, in some cases, up to 5 or 7 years to be confirmed. In the absence of appropriate medical technology, such delays and uncertainty can contribute to the increased seriousness and severity of these diseases.

"Time is a key success factor for people who suffer from mental diseases. diaMentis diagnostic assistance tool could have a very significant impact on their lives and those of their families. The speed and power of our novel technological approach are likely to be very useful to healthcare professionals dealing with mental health issues. The faster these diseases can be identified, the faster we can hope to offer adequate care and reduce long-term negative effects," said diaMentis President and CEO, Normand Tremblay.

"The technology we are developing makes it possible to analyze the information obtained from an electroretinogram, a simple and non-invasive eye examination. By developing new proprietary analysis methodologies and elaborating mathematical models better suited to the biomarkers expressed in various mental illnesses, we can add an objective measurement to the diagnostic process. This designation will allow us to interact with the FDA in order to leverage the development of our technology more effectively," added Vice President and Chief Scientific Officer, Dr Claude Hariton.

The FDA's expedited program
The Breakthrough Devices Program is an FDA program designed for, among other things, innovative medical devices that provide for more effective diagnosis of life-threatening or irreversibly debilitating diseases, such as certain mental illnesses. The objective of the Breakthrough Devices Program is to provide patients and healthcare providers with timely access to this technology by speeding up its development and review, while preserving the FDA high standards.

About diaMentis
Quebec-based medical technology developer diaMentis is a pioneer in the development of diagnostic support tools for various mental health disorders. It was established in Québec City in 2015 and employs 23 full-time staff. As a spin-off of Université Laval's Institut en santé mentale du Québec (IUSMQ) research work, diaMentis develops proprietary methods for the analysis of biomarkers present in retinal signals. For more information, visit

SOURCE diaMentis

For further information:

Valérie Chamula, Citoyen


bottom of page