950 FDA Authorized AI-Enabled Medical Devices
Margaretta Colangelo
Top Thought Leadership Voice | Leading AI Analyst, Speaker, Writer | AI Newsletter with 56,500+ subscribers
Since 1995, the FDA has authorized hundreds of AI-enabled medical devices via 510(k) clearance, granted De Novo request, or approved PMA. These AI based technologies are helping doctors detect malign changes such as tumors and hardening of the arteries and providing highly accurate measurements of organs and blood flow. One of the benefits of AI is the potential to extract important insights from the massive amount of medical data generated every day. Innovative companies have developed AI based tools across many medical specialties.
Yesterday the FDA published their updated list with 950 authorized AI-enabled medical devices. The FDA has authorized 68 new devices and added 16 new companies to the list since the last update in May 2024.
In today's AI In Healthcare Milestones newsletter I'm sharing a high level analysis of the devices on the FDA list with charts to visualize the data. I compare the new list with previous lists and show which medical specialties have the highest number of authorized AI-enabled devices.
1) Top Companies
2) Top 20 Companies Over Time
3) 16 New Companies Added To The List
4) 68 New Devices By Specialty
5) All 950 AI-Enabled Medical Devices By Specialty
Radiology has the highest number of authorizations and the steadiest increase of AI-enabled device submissions of any specialty.
6) Specialties Year Over Year
7) Specialties Year Over Year (log scale)
Past Analyses of the FDA's List
领英推荐
May 2024: 882 FDA Authorized AI-Enabled Devices
October 2023: 692 FDA Authorized AI-Enabled Devices
October 2022: 521 FDA Authorized AI-Enabled Devices
https://www.dhirubhai.net/pulse/fda-publishes-updated-list-521-authorized-aiml-margaretta-colangelo/
Note: All analysis and images in this newsletter were created by Margaretta Colangelo and Lambert Leong. If you use our analysis or images you must include a citation acknowledging Margaretta Colangelo and Lambert Leong as the source and provide a link to this newsletter.
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Copyright ? 2024 Margaretta Colangelo. All Rights Reserved.
This article was written by Margaretta Colangelo and Lambert Leong. Lambert is a Postdoctoral Researcher at the University of Washington, specializing in developing innovative deep learning models for identifying imaging biomarkers related to cancer treatment responses in clinical trials. Margaretta is a leading AI analyst who tracks significant milestones in AI in healthcare. She consults with AI healthcare companies and writes about some of the companies. Margaretta serves on the advisory board of the AI Precision Health Institute at the University of Hawai?i?Cancer Center @realmargaretta
MD.dermatologist.CHIEF INNOVATION OFFICER (C.I.O), DERMAI TECH.DERMATOLOGIST & COSMETOLOGIST, PRIVATE PRACTICE. CHAIRMAN AND MEMBER OF THE BOARD OF DIRECTORS & SHAREHOLDER, NOAVARAN ZIBAIE GOSTAR OFOGHE SABZ CO.
1 个月Thanks for sharing
Ph.D. | Pharmacology & Genetics | Project Management | Clinical Research | Women Empowerment
1 个月I am especially interested in learning more about the devices and the growing trend in Anesthesiology.
Global Product Marketing Director at GE Healthcare
2 个月Really interesting look at the status of A medical device enablement. Thanks for sharing! Look forward to seeing more AI created for use in areas beyond radiology and cardiology!
Senior Life Science Advisor & Consultant; Quality Management / Organizational development / Interim Management / Clinical Trials
2 个月Interesting! Looking forward to see more areas grow as I am convinced the demand is increasing.