Business Wire

Mosaic Clinical Technologies Announces FDA Breakthrough Device Designation for Cognita’s Generative AI Model for Radiology

Mosaic Clinical Technologies™, a wholly-owned subsidiary of Radiology Partners, is pleased to announce that Cognita™, its AI business unit developing ...
The American Journal of Managed Care

FDA Will Require Only 1 Study to Approve New Drugs, Speeding Up Process

A commentary by FDA officials Vinay Prasad, MD, MPH, and Martin Makary, MD, MPH, details the new system for drug approvals in the US. FDA Commissioner Martin Makary, MD, MPH, and his top deputy Vinay ...
Penn Live

Kennedy-era FDA changes vaccine review process, blocks Moderna application

WASHINGTON (AP) — The U.S. Food and Drug Administration is refusing to consider Moderna’s application for a new flu vaccine made with Nobel Prize-winning mRNA technology, the company announced Tuesday ...
Food Safety News

FDA warns seafood and acidified food processors about serious HACCP and process filing violations

As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not posted for public view until weeks or months ...
MarketWatch

eMurmur's Open Medical AI Receives FDA Clearance, Enabling Murmur Detection Across Digital Stethoscope Models and Third-Party Software

The MarketWatch News Department was not involved in the creation of this content. eMurmur Heart AI is the intelligence layer that can power auscultation hardware and software, providing accurate heart ...
Morningstar

eMurmur's Open Medical AI Receives FDA Clearance, Enabling Murmur Detection Across Digital Stethoscope Models and Third-Party Software

eMurmur Heart AI is the intelligence layer that can power auscultation hardware and software, providing accurate heart sound analysis in seconds OTTAWA, ON, Jan. 29, 2026 /PRNewswire/ -- eMurmur® is ...
InfoQ

Virtual Panel - AI in the Trenches: How Developers Are Rewriting the Software Process

Unlock the full InfoQ experience by logging in! Stay updated with your favorite authors and topics, engage with content, and download exclusive resources. Cory Benfield discusses the evolution of ...
JD Supra

Automation Bias and Clinical Practice: FDA Makes Incremental Updates to Clinical Decision Support Software Guidance

On January 6, 2026, the US Food and Drug Administration (FDA) revised its final guidance on Clinical Decision Support Software (2026 CDS Software Guidance). 1 The 2026 guidance, which supersedes the ...
aha.org

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 certain wearable devices) and the other related to clinical decision ...
TMCnet

InstantGMP Modernizes Software Validation with FDA Computer Software Assurance-Aligned Approach

InstantGMP categorizes software functions into low, moderate, and high process-risk groups. Low-risk features, such as equipment, room, deviation, and CAPA logs, primarily collect or tabulate data.
Morningstar

Hyperfine Announces FDA Clearance of the First Optive AI™ Software Update with Advanced Diffusion Imaging Capability, Focused on Enhancing Stroke Detection with the Swoop ...

Hyperfine Announces FDA Clearance of the First Optive AI™ Software Update with Advanced Diffusion Imaging Capability, Focused on Enhancing Stroke Detection with the Swoop® System A new multi-direction ...
CNBC

Dr. Gottlieb: FDA is systemically trying to dismantle components of the vaccine approval process

Former FDA Commissioner Dr. Scott Gottlieb joins 'Squawk Box' to discuss concerns over the FDA's sweeping changes to how the U.S. handles vaccinations, impact on the public trust in vaccines, ...