Canon Medical Secures FDA Clearance for Ultrasound Innovations, Advancing Image Clarity and Workflow Efficiency

Canon Medical Systems USA, Inc. recently received FDA 510(k) clearance for its Aplio i-series diagnostic ultrasound systems (Aplio i900, Aplio i800, and Aplio i700) with Software Version 9.0. This ...

Singular seeks US FDA application for cloud-based medtech platform

Singular Health Group has formally submitted a 510(k) notification to the US Food and Drug Association to sell its innovative ...
TipRanks on MSN

Singular Health Advances U.S. Market Presence with FDA Submission for 3DICOM MD™ Cloud

The latest announcement is out from Singular Health Group Ltd ( ($AU:SHG) ). Singular Health Group Ltd has submitted a 510(k) premarket ...

Canon Medical Systems USA Receives FDA 510(k) Clearance for Alphenix / Evolve Edition with αEvolve Imaging – Debuted at TCT 2025

Canon Medical Systems USA showcased the Alphenix/Evolve Edition with αEvolve Imaging at the Transcatheter Cardiovascular Therapeutics (TCT) Conference, which was held from October 25 to 28, 2025, at ...
MassDevice

EDAP wins FDA nod for robotic high-intensity focused ultrasound system workflows

EDAP TMS SA announced today that the FDA granted 510(k) clearance for new workflows for its ultrasound technology.
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 ...
HealthLeaders Media

GE HealthCare wins FDA Authorization for deep-learning mammography tech

GE HealthCare said it has received FDA Premarket Authorization for Pristina Recon DL, a deep-learning–powered 3D mammography reconstruction technology the company says improves image sharpness and ...
Becker's ASC

Vital Images Receives FDA Clearance for 3-D Viewing Through VitreaView

Vital Images, a Toshiba Medical Systems Group Co., has announced it has received FDA clearance for three-dimensional viewing through its VitreaView viewer, according to a news release (pdf). The ...
Healio

FDA clears next-generation image system to guide cardiac interventions

Please provide your email address to receive an email when new articles are posted on . The FDA granted 510(k) clearance to a new image-guided system for use during interventional CV procedures. The ...
MassDevice

Paradromics gets FDA green light for BCI study

Paradromics announced that it received FDA investigational device exemption (IDE) to begin a study of its brain-computer ...
Healio

FDA grants 510(k) clearance for software to image the brain’s white matter

Please provide your email address to receive an email when new articles are posted on . The FDA has granted 510(k) clearance to a Canadian neuroimaging company for its quantitative imaging software, ...