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 the Week of Oct. 2, 2023
FDA Updates for the Week of Oct. 2, 2023 unknown
Oncology Drug Exkivity to be Withdrawn from U.S. Market
FDA to form advisory committee for digital health and AI
FDA to form advisory committee for digital health and AI unknown
FDA to form advisory committee for digital health and
FDA Updates for the Week of Sept. 25, 2023
FDA Updates for the Week of Sept. 25, 2023 unknown
FDA Approves New Pompe Therapy
The FDA has approved a
We know how to regulate new drugs and medical devices–but we’re about to let health care AI run amok
We know how to regulate new drugs and medical devices–but we’re about to let health care AI run
FDA Updates for the Week of Sept. 18, 2023
FDA Updates for the Week of Sept. 18, 2023 unknown
FDA Approves GSK’s Myelofibrosis Drug
The FDA has approved
Welldoc Lands 11th FDA Clearance with BlueStar
Welldoc Lands 11th FDA Clearance with BlueStar unknown
In a remarkable display of innovation and dedication to improving chronic care,
Withings wins FDA clearance for scale with AFib detection
Withings wins FDA clearance for scale with AFib detection unknown
Dive Brief:
* Withings has received 510(k) clearance for a
FDA Updates for the Week of Aug. 28, 2023
FDA Updates for the Week of Aug. 28, 2023 unknown
FDA Approves Reblozyl as First-Line Treatment in MDS-Related Anemia
The
AION Receives FDA Clearance for Its iTempShield Skin-Wearable Device and Software Platform for Professional and Retail Environments
Technology Designed for Multiple Applications, with Initial Focus on Early Infection Detection and Treatment
August 30, 2023 07:05 AM