Artificial Intelligence and Machine Learning (AI/ML)-Enabled Medical Devices
October 19, 2023 update: 171 Artificial Intelligence and Machine Learning (AI/ML)-Enabled Medical Devices were added to the list
FDA Updates for Week of June 26, 2023
FDA Updates for Week of June 26, 2023 unknown
FDA Approves $2.9 Million Gene Therapy for Hemophilia A
The
iHealthScreen receives FDA 510(k) for AI-enabled eye screening system
iHealthScreen receives FDA 510(k) for AI-enabled eye screening system unknown
iHealthScreen, maker of AI-enabled software for retinal imaging, received
FDA has now cleared more than 500 healthcare AI algorithms
Dave Fornell | February 06, 2023 | Artificial Intelligence
There are now more than 520 marker-cleared artificial intelligence (AI) medical algorithms available
State Legislative And Regulatory Telehealth Updates
State Legislative And Regulatory Telehealth Updates unknown
Amanda Enyeart is an associate in the law firm of McDermott Will &
FDA Roundup: March 24, 2023
FDA Roundup: March 24, 2023 FDA For Immediate Release: March 24, 2023
Today, the U.S. Food and Drug Administration
FDA updates for Week of March 6, 2023
FDA updates for Week of March 6, 2023 unknown
FDA approves novel nasal spray for migraine.
The FDA has approved
Theranica receives FDA 510(k) for migraine prevention device
Theranica receives FDA 510(k) for migraine prevention device unknown
Prescription digital therapeutic developer Theranica announced it had received FDA
FDA Updates for Week of Feb. 27, 2023
FDA Updates for Week of Feb. 27, 2023 unknown
FDA approves Kevzara for inflammatory rheumatic disease.
The FDA has approved
FDA Updates for Week of Feb. 20, 2023
FDA Updates for Week of Feb. 20, 2023 unknown
FDA approves weekly hemophilia A therapy.
The FDA has approved Altuviiio