MedTech Dive1d
J&J’s Monarch robot wins FDA nod for AI software update
Using Nvidia and GE Healthcare technology, the robotic surgery system is intended to help doctors detect lung cancer earlier.
STAT1d
Study reveals how often medical device makers report safety incidents late to FDA
Most medical devices in the United States come to market with limited clinical data, and device surveillance is viewed as a ...
Medical Device Network 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 ...
The BMJ2d
Late adverse event reporting from medical device manufacturers to the US Food and Drug Administration: cross sectional study
Objective To describe the extent of late adverse event reporting by manufacturers to the US Food and Drug Administration’s (FDA) Manufacturer And User Facility Device Experience (MAUDE) database as ...
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, ...
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 ...
MassDevice7d
FDA clears revision knee implant from Zimmer Biomet
Zimmer Biomet (NYSE: ZBH) announced today that it received FDA 510(k) clearance for its Persona Revision SoluTion Femur.
MassDevice14d
Johnson & Johnson MedTech resumes Varipulse sales after stroke-related pause
They cited a report of a stroke in the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database ... the first 132 procedures after FDA approval in November 2024.
National Institute for Health and Care Excellence14d
New drug approved for inherited clotting disorder, offering simpler dosing and enhanced quality of life.
Efanesoctocog alfa (also called Altuvoct and made by Swedish Orphan Biovitrum) can be given as a once-weekly injection instead of some current treatments that are given several times a week. Affecting ...
Hoodline15d
Ohio State Highway Patrol Boosts Drug Interdiction Efforts with New K-9 Member, Ragnar
As the Ohio State Highway Patrol continues to adapt its strategies against drug trafficking, the integration of K-9 members such as Ragnar into their operations is poised to push back against the ...