DrBicuspid

FDA clears 1st image review app for iPads, iPhones

The U.S. Food and Drug Administration (FDA) has issued 510(k) marketing clearance for MIM Software's Mobile MIM application, the first mobile image viewing application to receive clearance for ...
MassDevice

Elekta gets FDA nod for AI-powered linear accelerator for radiology

Elekta announced today that its Evo CT Linac received FDA 510(k) clearance, making it available to U.S. radiation oncology ...
MassDevice

Siemens Healthineers wins FDA nod for helium-free MRI system

Siemens Healthineers announced today that it received FDA clearance for its 70cm bore Magnetom Flow magnetic resonance ...
Seeking Alpha

Hyperfine Announces FDA Clearance of Optive AI™ Software, Introducing the Most Substantial Image Quality Improvement Ever for the Swoop® System

Latest Swoop® System software delivers a substantial leap in image quality for AI-powered portable MR brain imaging. GUILFORD, Conn.--(BUSINESS WIRE)-- Hyperfine, Inc. (HYPR), the groundbreaking ...
East Oregonian

Subtle Medical’s SubtleHD™ Awarded FDA Clearance, Setting a New Benchmark for MRI Image Quality and Speed

With FDA clearance of SubtleHD™, Subtle Medical launches Subtle-ELITE™, an industry-first AI package designed to achieve superior image quality, unprecedented speed, and workflow automation Compared ...
Naija Gist - Latest

FDA Issues New Images to Add to Warnings on Cigarette Packages

So are the grief-stricken woman, the man struggling to smoke despite a hole in his windpipe and the rotting teeth. Nine years after the Food and Drug Administration first proposed graphic images as ...
Morningstar

Hyperfine Announces FDA Clearance of a New Next-Generation Swoop® System Powered by Optive AI™ Software, Delivering a Transformative Leap in Image Quality

Hyperfine Announces FDA Clearance of a New Next-Generation Swoop® System Powered by Optive AI™ Software, Delivering a Transformative Leap in Image Quality This major Swoop® system scanner redesign and ...
Morningstar

Techsomed Receives FDA 510(k) Clearance Expanding BioTraceIO360 Platform to Kidney Ablation Advancing a Unified Multi-Organ Image-Guided Therapy Platform

TEL AVIV, Israel, Sept. 22, 2025 /PRNewswire/ -- Techsomed, a leader in AI-Driven Precision for Image-Guided Care, today announces U.S. FDA 510 (k) clearance expanding indications for BioTraceIO360* ...
The Daily Astorian

Subtle Medical’s SubtleHD™ Awarded FDA Clearance, Setting a New Benchmark for MRI Image Quality and Speed

Compared with other image enhancement solutions, Subtle-ELITE™ drives greater value to radiologists and imaging institutions by combining three new tools into one package that optimizes the MRI ...