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ISSN 2063-5346
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CURRENT SCENARIO AND REGULATORY APROVAL PROCESS OF AI/ML BASED MEDICAL DEVICES

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K. VENKATESWARA RAJU, M. BEULAH MANASA, PENDYALA TEJA, M. JANVI SU-SHMA NAIDU, EDA SUJAN WESLY, LAKSHMI PRASANTHI NORI *
» doi: 10.48047/ecb/2023.12.10.278

Abstract

Medical devices based on artificial intelligence and machine learning (AI/ML) have become more popular. In the modern days of healthcare, the role of AI, an emerging technology, in healthcare institutions is on the rise. AI technology is employed to diagnose diseases, the choice of therapies, and the education of healthcare professionals. It has the ability to solve a variety of issues in the healthcare system. AI offers great potential for countries now struggling with over-crowded healthcare systems and a physician shortage. AI offers great potential for countries now struggling with overcrowded healthcare systems and a physician shortage. Modern healthcare institutions rely heavily on technology. Machine learning (ML)-based medical devices are being employed more often in the healthcare industry as a result of the rapid advancements in artificial intelligence (AI) during the past ten years. Applications of machine learning (ML) are signifi-cantly altering the healthcare industry. The main objective of ML, is to increase the efficiency and precision of medical practise. An ILD-panel constituting pathologists, radiologists and pul-monologists in some hospitals now makes the diagnosis of interstitial lung disease (ILD). Ma-chine-learning algorithms are an example of how AI may be applied in healthcare.

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