As artificial intelligence (AI) has been highly advancing in the last decade, machine learning (ML) based medical devices are increasingly used in healthcare. In this article, we did an extensive search on the FDA database and performed an analysis of FDA-approved Artificial Intelligence and Machine Learning (AI/ML)-Enabled Medical Devices. We have presented all the listed AI/ML-Enabled Medical Devices according to the date of approval, medical specialty, implementation modality of Medical Devices, anatomical site of use, and brief summary of each tool. Furthermore, we presented the approval pathways based on FDA currently updated criteria and risk level. according to the date of approval, medical specialty, implementation modality of Medical Devices, anatomical site of use, and brief summary of each tool. Furthermore, we presented the approval pathways based on FDA currently updated criteria and risk level.

As artificial intelligence (AI) has been highly advancing in the last decade, machine learning (ML) based medical devices are increasingly used in healthcare. In this article, we did an extensive search on FDA database and performed analysis of FDA approved Artificial Intelligence and Machine Learning (AI/ML)-Enabled Medical Devices. We have presented all the listed AI/ML-Enabled Medical Devices according to the date of approval, medical specialty, implementation modality of Medical Devices, and anatomical site of use. Our summary includes the current landscape of FDA approved AI/ML-Enabled Medical Devices till date and different FDA approval pathways for medical devices which will help understand the overview of AI/ML-Enabled Medical Devices, and its overall trends.

This study analyzes FDA approved novel therapeutic drugs over the past three decades to identify trends in drug development. The study collected and analyzed information on drug attributes, approval types, and targeted diseases for drugs approved between 1991 and 2023. Results show that the FDA has approved 1096 novel drugs, with 79% being new molecular entities (NME) and 21% being biologics. Priority review was granted to 46% of the drugs, and 34% were given orphan status. Breakthrough therapy status was granted for 11% of the drugs, and 7% received accelerated approval. Novartis sponsored the highest number of approved drugs, with 54 in total. Around 22% of the drugs approved were cancer-related, with lung and breast cancer being the top two types. The study concludes that FDA's regulatory incentives could facilitate the pharmaceutical industry in addressing new challenges and bringing innovation in the future. A user-friendly web portal and application is in development to allow user to access updated comprehensive information of novel drugs all in one place.