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Dec
10

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
2 min read
Nov
08

FDA Roundup: November 3, 2023

FDA Roundup: November 3, 2023 unknownFor Immediate Release:November 03, 2023 Today, the U.S. Food and Drug Administration is
2 min read
Oct
11

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FDA Updates for the Week of Oct. 2, 2023 unknown Oncology Drug Exkivity to be Withdrawn from U.S. Market
4 min read
Oct
11

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
3 min read
Oct
03

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
4 min read
Oct
03

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
5 min read
Sep
23

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
3 min read
Sep
05

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,
2 min read
Sep
03

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
1 min read
Sep
03

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
3 min read