Avant Technologies, Inc. and its partner, Ainnova Tech, Inc., (Ainnova), a leading healthcare technology company focused on revolutionizing early disease detection using artificial intelligence (AI), announced that the Company has started designing its clinical trial protocol ahead of a pre-submission meeting with the U.S. Food and Drug Administration (FDA). The pre-submission meeting is to request guidance on the clinical testing needed for its Vision AI platform in the early detection of diabetic retinopathy, and Ainnova’s clinical trial will culminate in the submission of an FDA 510(k) to obtain clearance from the regulatory agency to market its technology.
Health Technology Insights: Sensitek and GRTHealth Partner to Revolutionize Aging-in-Place
Ainnova has hired an ophthalmologist, who is assisting in drafting the requirements for the clinical trial protocol that the Company’s Contract Research Organization (CRO), Fortrea, has requested. Upon completion of the protocol, Ainnova will work with its CRO to prepare and send all the documentation to the FDA for its upcoming pre-submission meeting. A clinical trial protocol is a detailed, written plan that outlines the objectives, design, methodology, and organization of a clinical research project, ensuring the safety of participants and the integrity of data collected. The Company expects its pre-submission meeting with the FDA to occur in midMay 2025.
Health Technology Insights: PathAI Expands AISight Digital Pathology Adoption with Four New Laboratory Partners
Ai-nova Acquisition Corp. (AAC), the Company formed by the partnership between Avant and Ainnova to advance and commercialize Ainnova’s technology portfolio, including its Vision AI platform and its versatile retinal cameras, has the global licensing rights for this portfolio, so the success of Ainnova’s interactions with the FDA are paramount to marketing the technology portfolio in the United States.
For medical device applicants like Ainnova, the FDA’s pre-submission program is useful to determine a clear regulatory pathway for the successful launch of the device, including the number of patients and the number of clinics needed to generate the necessary clinical data for the FDA to make an informed decision on Ainnova’s Vision AI platform. For Avant, the presubmission meeting will help define a precise budget for the strategic partnership’s entire FDA process.
Health Technology Insights: Survey Predicts High Turnover Rates Among Healthcare Executives
To participate in our interviews, please write to our HealthTech Media Room at sudipto@intentamplify.com
Source – PR Newswire
