FDA Grants De Novo Authorization to AI Diagnostic Tools from Imvaria and Darmiyan

The Food and Drug Administration (FDA) has recently granted De Novo authorization to artificial intelligence (AI) diagnostic tools developed by Imvaria and Darmiyan, marking a significant advancement in the field of medical diagnostics.

Imvaria's diagnostic tool, named Fibresolve, received authorization for its capability to analyze CT scans and identify patterns indicative of idiopathic pulmonary fibrosis (IPF). The deep learning algorithm employed by Fibresolve has demonstrated the potential to reduce the need for invasive lung biopsies, showcasing its efficacy in non-invasive diagnosis. The company estimates that there is an average delay of almost 2 1/2 years between the onset of symptoms and the diagnosis of IPF, emphasizing the importance of early detection and intervention.

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Joshua Reicher, co-founder and CEO of Imvaria, stated, "Fibresolve serves as an adjunct to clinicians in assessing patients with suspected lung fibrosis to provide a diagnostic subtype classification, potentially facilitating proper treatments at an earlier stage of the disease process."

Darmiyan's Brainsee, another AI diagnostic tool, received FDA authorization for its software that utilizes MRI scans of a patient's brain and their cognitive test scores to predict the likelihood of progression from mild cognitive impairment (MCI) to Alzheimer's dementia within five years. BrainSee is built on the company’s patented core proprietary technology, combining advanced whole-brain image analysis and medical AI to address the critical need for early detection and management of brain diseases.

The approval of BrainSee marks a pivotal advancement in brain health, offering an objective scoring system to predict dementia risk. With an estimated 10 million Americans and over 100 million patients worldwide grappling with amnestic MCI (aMCI), BrainSee addresses a critical unmet need. Darmiyan emphasizes that the ability of BrainSee to predict dementia risk could enable timely and personalized treatments for high-risk patients while reducing the need for invasive and costly tests for lower-risk individuals.

Both the companies, diagnostic tools were part of the FDA's breakthrough program, showcasing their potential to revolutionize medical diagnostics. These AI-enabled technologies join a cohort of breakthrough devices, including those from companies like Caption Health, Paige, and Renalytix AI, that have received FDA authorization.

The FDA's De Novo authorization for these AI diagnostic tools reflects a growing trend in leveraging advanced technologies to enhance diagnostic accuracy and enable early intervention. As the healthcare industry continues to embrace AI and machine learning, these developments hold promise for improving patient outcomes and reducing the burden on both healthcare systems and individuals.