GlobalData on MSN1d
FDA grants 510(k) clearance for J&J MedTech’s Monarch Quest
The US Food and Drug Administration (FDA) has granted 510(k) clearance for Johnson & Johnson (J&J) MedTech’s Monarch Quest ...
Medical Device Network on MSN4d
FDA grants 510(k) clearance to Zimmer’s new revision knee implant component
The US Food and Drug Administration (FDA) has granted 510(k) clearance to Zimmer Biomet's new revision knee implant component ...
JD Supra1h
FDA’s Backup LDT Enforcement Method: Specimen Collection Kits
We have written at length about the U.S. Food and Drug Administration’s (FDA’s) actions to promulgate regulations specifying the agency’s authority ...
NeuroOne® Accelerates Timeline of 510(k) Submission to FDA for the OneRF® Trigeminal Nerve Ablation System to Treat Facial Pain
Submission for New Intended Use That Leverages Company’s Patented OneRF® Technology Platform Expected in May 2025 EDEN PRAIRIE, Minn., March 11, ...
MassDevice22h
Lifeward wins FDA nod for next-gen exoskeleton
Lifeward announced today that it received FDA 510(k) clearance for its latest-generation personal exoskeleton device, ReWalk ...
F.A.S.T.® aiCockpit® CT Lung Nodule Software Receives FDA 510(k) Clearance
Provides Efficient Interaction with Consolidated AI ResultsPALO ALTO, Calif., March 03, 2025 (GLOBE NEWSWIRE) -- Fovia Ai, ...
MassDevice22h
Spineart, eCential Robotics earn FDA nod for robotic-assisted spine surgery application
Spineart and eCential Robotics today announced the receipt of FDA 510(k) clearance for the use of an application for robotic ...
Standard-Journal1d
Perfuze Receives FDA 510(k) Clearance for Zipline™ Access Catheters and Secures €22M in Additional Funding
Perfuze is a medical device company headquartered in Galway, Ireland, dedicated to developing next-generation catheter-based ...
Business Wire10d
Epredia Receives U.S. FDA 510(K) Clearance for the E1000 Dx™ Digital Pathology Solution Designed to Improve Laboratory Workflow in Cancer Diagnostics
6523), today announced U.S. Food and Drug Administration (FDA) 510(K) clearance for its E1000 Dx Digital Pathology Solution (E1000 Dx). The E1000 Dx consists of a high-speed, automated ...
Perfuze Receives FDA 510(k) Clearance for Zipline Access Catheters and Secures €22M in Additional Funding
Perfuze, a leading medical device company dedicated to advancing stroke treatment, today announced that it has received FDA ...