Aiforia Technologies Plc, Press Release, October 20, 2023 at 10:00 a.m. EEST
Aiforia Technologies Plc initiates a path to secure regulatory approval for its first product in the United States. The Food and Drug Administration (FDA) is responsible for market surveillance of medical devices in the U.S. Together with a local consulting company, Aiforia is planning and implementing the necessary steps to submit an application to the FDA during 2024.
“The demand for digital pathology image analysis in clinical diagnostics is increasing in the U.S. We want to ensure that we are well prepared to offer our solutions to an increasingly wide range of customers.,” says Jukka Tapaninen, CEO of Aiforia.
Aiforia equips pathologists and scientists in preclinical and clinical labs with powerful deep-learning artificial intelligence software for translating images into discoveries, decisions, and diagnoses. The cloud-based Aiforia products and services aim to escalate the efficiency and precision of medical image analysis beyond current capabilities across various fields, from oncology to neuroscience and more. Find out more at www.aiforia.com