Fortrea hired to help prep disease detection AI for FDA review
Fortrea will help design and run clinical trials of an AI detection device for diabetic retinopathy under a new contract with developers Avant Technologies and Ainnova Tech.
The contract will see Fortrea help Houston, Texas-based Ainnova seek FDA guidance on the clinical testing needed to prove the efficacy of its Vision AI platform. Financial terms of the deal were not provided.
The CRO has also agreed to work with Ainnova on its FDA submission, run any required clinical studies, and compile the resulting 510(k) documentation seeking clearance to market the technology in the US.
Ainnova CEO Vinicio Vargas said, “We worked diligently to identify and select the right CRO to help us both engage the FDA and then conduct our clinical studies.
“Fortrea is an established and highly regarded full-service CRO with expertise in more than 20 therapeutic areas, and a CRO with an extensive portfolio of successfully completed clinical trials, including those involving both emerging and large biopharmaceutical, medical device, and diagnostic companies.”
Ainnova aims to submit its pre-submission meeting application in the coming weeks and to meet with the FDA in late March or early April.
The firm also plans to ask the US regulatory agency how to obtain clearance to use four other early detection algorithms that it recently acquired.
The technologies - which can assess the risk of cardiovascular disease, prediabetes, Type 2 diabetes, fatty liver disease and chronic kidney disease – have potential application in healthcare screening and clinical trial recruitment.
Fortrea – which split from Labcorp in 2023 – has extensive experience with AI. For example, in November 2023, it teamed with Medidata to use AI to increase access to diverse patients in clinical trials.
Also, in that same month, Fortrea announced it had invested in AI-enabled technologies that optimize bed space utilization, clinic scheduling, and the application of failure modes and effects analysis at sites in the UK and US.
More recently, the CRO set up an innovation studio to use AI technologies to optimize various clinical development processes.
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