JD Supra

FDA Issues Draft Predetermined Change Control Plan for Machine-Learning-Enabled Device Software Functions

On April 3, 2023, the US Food and Drug Administration (FDA) published its draft guidance, Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial ...
American Hospital Association

FDA issues guidance on wellness products, clinical decision support software

The Food and Drug Administration today released two guidance documents; one related to low-risk wellness products (including ...
JD Supra

New guidance on AI-enabled device software functions clarifies information FDA expects in marketing applications

On January 7, 2024, the U.S. Food and Drug Administration (FDA) published the draft guidance “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission ...
Healio

FDA grants fast track status to LB1148 for quicker return of postoperative bowel function

Please provide your email address to receive an email when new articles are posted on . FDA granted fast track designation to Palisade Bio’s broad-spectrum serine protease inhibitor, LB1148, for ...
Longview News-Journal

MediBeacon® Transdermal GFR System Receives FDA Approval to Assess Kidney Function

"The approval of the TGFR by the FDA demonstrates our proprietary system can provide an effective option for assessing kidney function," said Steve Hanley, CEO of MediBeacon. "According to the ...
Targeted Oncology

Key FDA Oncology Approvals in 2025: Precision Therapies and New Targets

On August 8, 2025, the FDA granted accelerated approval to zongertinib for adult patients with unresectable or metastatic ...